U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Description

Semaglutide (trade name Ozempic) is a pharmaceutical drug in development by a Danish company Novo Nordisk for the treatment of type 2 diabetes. Semaglutide is a once-daily glucagon-like peptide-1 analog that differs to others by the presence of an acyl group with a steric diacid at Lys26 and a large synthetic spacer and modified by the presence of a α-aminobutyric acid in position 8 which gives stability against the dipeptidylpeptidase-4. Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological hormone that has multiple actions on glucose, mediated by the GLP-1 receptors. The principal mechanism of protraction resulting in the long half-life of semaglutide is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilized against degradation by the DPP-4 enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose-dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase.

Originator

Approval Year

2017
411
Targets

Targets

Primary TargetPharmacologyConditionPotency
Agonist
2752
 6.2 pM [EC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8583
OZEMPIC

Approved Use

OZEMPIC is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Launch Date

2017
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
9.5 nM
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
9.7 nM
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
3026 nM × h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
3080 nM × h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
150 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
151 h
EXPERIMENT
https://pubmed.ncbi.nlm.nih.gov/29205786
0.5 mg single, subcutaneous
dose: 0.5 mg
route of administration: Subcutaneous
experiment type: SINGLE
co-administered:
SEMAGLUTIDE plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
1%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
unknown, unknown
 SEMAGLUTIDE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Other AEs: Nausea, Vomiting...
Other AEs:
Nausea
Vomiting
Dyspepsia
Headache
Decreased appetite
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Other AEs: Nausea, Vomiting...
Other AEs:
Nausea
Vomiting
Dyspepsia
Headache
Decreased appetite
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Disc. AE: Nausea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Nausea (2.9%)
Vomiting (1.7%)
Diarrhea (0.9%)
Abdominal pain (0.6%)
Abdominal pain upper (0.5%)
Abdominal discomfort (0.4%)
Dyspepsia (0.3%)
Constipation (0.3%)
Abdominal distension (0.3%)
Gastritis (0.2%)
GERD (0.2%)
Pancreatitis acute (0.2%)
Decreased appetite (0.7%)
Weight decreased (0.3%)
Lipase increased (0.2%)
Asthenia (0.2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
20 mg 1 times / day single, oral
Highest studied dose
Dose: 20 mg, 1 times / day
Route: oral
Route: single
Dose: 20 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 34.8 years
Health Status: healthy
Age Group: mean age 34.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
1.5 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.5 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.5 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/29799100/
healthy, mean age 37.7 years
Health Status: healthy
Age Group: mean age 37.7 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/29799100/
Sources:
https://pubmed.ncbi.nlm.nih.gov/29799100/
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Disc. AE: Lipase increased, Decreased appetite...
Other AEs: Nausea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Lipase increased (12.5%)
Decreased appetite (6.25%)
Nausea (6.25%)
Vomiting (3.1%)
Other AEs:
Nausea (46.9%)
Vomiting (40.6%)
Eructation (43.8%)
Abdominal pain (28.1%)
Diarrhoea (12.5%)
Abdominal distension (21.9%)
Dyspepsia (31.3%)
Abdominal discomfort (15.6%)
Flatulence (12.5%)
Abdominal pain upper (9.4%)
Infrequent bowel movements (9.4%)
Toothache (12.5%)
Decreased appetite (78.1%)
Nasopharyngitis (31.3%)
Headache (37.5%)
Fatigue (25%)
Asthenia (9.4%)
Lipase increased (21.9%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Disc. AE: Lipase increased, Vomiting...
Other AEs: Nausea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Lipase increased (9.1%)
Vomiting (9.1%)
Aortic aneurysm (9.1%)
Other AEs:
Nausea (54.5%)
Vomiting (45.5%)
Eructation (27.3%)
Diarrhoea (18.2%)
Abdominal distension (9.1%)
Dyspepsia (36.4%)
Abdominal discomfort (27.3%)
Flatulence (9.1%)
Abdominal pain upper (9.1%)
Decreased appetite (90.9%)
Nasopharyngitis (18.2%)
Headache (36.4%)
Fatigue (18.2%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Disc. AE: Gastrointestinal disorder (NOS)...
Other AEs: Nausea, Vomiting...
AEs leading to
discontinuation/dose reduction:
Gastrointestinal disorder (NOS)
Other AEs:
Nausea (57.4%)
Vomiting (27.7%)
Diarrhea (23.4%)
Dyspepsia (12.8%)
Constipation (6.4%)
Nasopharyngitis (6.4%)
Gastroenteritis (4.3%)
Urinary tract infection (4.3%)
Fatigue (12.8%)
Asthenia (10.6%)
Anorexia (31.9%)
Decreased appetite (17%)
Musculoskeletal and connective tissue disorders (8.5%)
Hypertension (2.1%)
Injury, poisoning and procedural complications (8.5%)
Skin and subcutaneous tissue disorders (2.1%)
Respiratory, thoracic and mediastinal disorders (2.1%)
Cardiac disorders (2.1%)
Psychiatric disorders (2.1%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Disc. AE: Nausea, Diarrhea...
AEs leading to
discontinuation/dose reduction:
Nausea
Diarrhea
Vomiting
Constipation
Abdominal pain
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
unknown
Health Status: unknown
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
Other AEs: Thyroid tumor...
Other AEs:
Thyroid tumor
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
AEs

AEs

AESignificanceDosePopulation
Decreased appetite
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Dyspepsia
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Headache
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Nausea
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Vomiting
20 ug/kg 1 times / day single, subcutaneous
Highest studied dose
Dose: 20 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 20 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Decreased appetite
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Dyspepsia
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Headache
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Nausea
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Vomiting
15 ug/kg 1 times / day single, subcutaneous
MTD
Dose: 15 ug/kg, 1 times / day
Route: subcutaneous
Route: single
Dose: 15 ug/kg, 1 times / day
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://distribute.m-anage.com/check.pic?path=events%5C176%5Cabstract%5C25575%5C343995_826.pdf
Asthenia 0.2%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
GERD 0.2%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Gastritis 0.2%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Lipase increased 0.2%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Pancreatitis acute 0.2%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Abdominal distension 0.3%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Constipation 0.3%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Dyspepsia 0.3%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Weight decreased 0.3%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Abdominal discomfort 0.4%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Abdominal pain upper 0.5%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Abdominal pain 0.6%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Decreased appetite 0.7%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Diarrhea 0.9%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Vomiting 1.7%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Nausea 2.9%
Disc. AE
8 mg 1 times / day multiple, oral
Recommended
Dose: 8 mg, 1 times / day
Route: oral
Route: multiple
Dose: 8 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
unhealthy, adult
Health Status: unhealthy
Age Group: adult
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000MedR.pdf
Diarrhoea 12.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Flatulence 12.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Toothache 12.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Lipase increased 12.5%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal discomfort 15.6%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal distension 21.9%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Lipase increased 21.9%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Fatigue 25%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal pain 28.1%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Vomiting 3.1%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Dyspepsia 31.3%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Nasopharyngitis 31.3%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Headache 37.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Vomiting 40.6%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Eructation 43.8%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Nausea 46.9%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Decreased appetite 6.25%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Nausea 6.25%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Decreased appetite 78.1%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal pain upper 9.4%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Asthenia 9.4%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Infrequent bowel movements 9.4%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
healthy, mean age 40.8 years
Health Status: healthy
Age Group: mean age 40.8 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Diarrhoea 18.2%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Fatigue 18.2%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Nasopharyngitis 18.2%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal discomfort 27.3%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Eructation 27.3%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Dyspepsia 36.4%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Headache 36.4%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Vomiting 45.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Nausea 54.5%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal distension 9.1%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Abdominal pain upper 9.1%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Flatulence 9.1%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Aortic aneurysm 9.1%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Lipase increased 9.1%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Vomiting 9.1%
Disc. AE
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Decreased appetite 90.9%
40 mg 1 times / day multiple, oral
Highest studied dose
Dose: 40 mg, 1 times / day
Route: oral
Route: multiple
Dose: 40 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
unhealthy, mean age 55.3 years
Health Status: unhealthy
Age Group: mean age 55.3 years
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/30565096/
Asthenia 10.6%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Dyspepsia 12.8%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Fatigue 12.8%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Decreased appetite 17%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Cardiac disorders 2.1%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Hypertension 2.1%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Psychiatric disorders 2.1%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Respiratory, thoracic and mediastinal disorders 2.1%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Skin and subcutaneous tissue disorders 2.1%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Diarrhea 23.4%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Vomiting 27.7%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Anorexia 31.9%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Gastroenteritis 4.3%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Urinary tract infection 4.3%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Nausea 57.4%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Constipation 6.4%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Nasopharyngitis 6.4%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Injury, poisoning and procedural complications 8.5%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Musculoskeletal and connective tissue disorders 8.5%
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Gastrointestinal disorder (NOS) Disc. AE
1.6 mg 1 times / week multiple, subcutaneous
Highest studied dose
Dose: 1.6 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1.6 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
unhealthy, mean age 56.4 years
Health Status: unhealthy
Age Group: mean age 56.4 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/26358288/
Abdominal pain Disc. AE
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Constipation Disc. AE
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Diarrhea Disc. AE
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Nausea Disc. AE
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Vomiting Disc. AE
1 mg 1 times / week multiple, subcutaneous
Recommended
Dose: 1 mg, 1 times / week
Route: subcutaneous
Route: multiple
Dose: 1 mg, 1 times / week
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
unhealthy, mean age 59.5 years
Health Status: unhealthy
Age Group: mean age 59.5 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/31539622/
Thyroid tumor
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
unknown
Health Status: unknown
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
2438
inhibitor
2507
inhibitor
2217

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
2153

CYP2B6
926

CYP2C8
1057

CYP2C19
2057

CYP3A4/5
296

OATP1B1
1079

OATP1B3
961

OAT1
725

OAT3
747

OCT2
779

P-gp
1741

BCRP
910
CYP1A2
832

CYP2B6
669

CYP3A4/5
133
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
985
 no
CYP1A2
2333
 no
CYP2B6
1160
 no
CYP3A4/5
357
 no
OAT1
730
 no
OAT3
749
 no
OCT2
782
 no
P-gp
1932
 no
OATP1B3
970
 yes [IC50 2.95 uM]
OATP1B1
1095
 yes [IC50 3.5 uM]
CYP3A4/5
357
 yes [IC50 >40 uM]
CYP1A2
2333
 yes [IC50 >5 uM]
CYP2B6
1160
 yes [IC50 >5 uM]
CYP2C19
2141
 yes [IC50 >5 uM]
CYP2C8
1117
 yes [IC50 >5 uM]
CYP2C9
2497
 yes [IC50 >5 uM]
CYP2D6
2546
 yes [IC50 >5 uM]
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
2263
PubMed

PubMed

TitleDatePubMed
Safety and efficacy of once-weekly semaglutide vs additional oral antidiabetic drugs in Japanese people with inadequately controlled type 2 diabetes: A randomized trial.
2018-05
Semaglutide: First Global Approval.
2018-02
Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial.
2018-02
Semaglutide seems to be more effective the other GLP-1Ras.
2017-12
Semaglutide-the "new kid on the block" in the field of glucagon-like peptide-1 receptor agonists?
2017-12
Patents

Patents

CN104356224A
1
EP2512518A1
1
WO2014005858A1
1
WO2017186896A1
1

Sample Use Guides

In Vivo Use Guide
Start at 0.25 mg once weekly. After 4 weeks, increase the dose to 0.5 mg once weekly. If after at least 4 weeks additional glycemic control is needed, increase to 1 mg once weekly (2.1).  Administer once weekly at any time of day, with or without meals (2.1).  If a dose is missed administer within 5 days of missed dose (2.1).  Inject subcutaneously in the abdomen, thigh, or upper arm (2.2).
Route of Administration: Other
In Vitro Use Guide
Semaglutide displaced [125I]-GLP1 from human GLP1 receptor expressed in BHK cells after 2 hrs in absence of human serum albumin with the IC50 value of 0.38 nM.
Substance Class Protein
Created
by admin
on Wed Apr 02 05:28:43 GMT 2025
Edited
by admin
on Wed Apr 02 05:28:43 GMT 2025
Protein Type PEPTIDE
Protein Sub Type
Sequence Type COMPLETE
Record UNII
53AXN4NNHX
Record Status FAILED
Record Version
  • Download
Name Type Language
semaglutide [INN]
Preferred Name English
SEMAGLUTIDE
INN   USAN   WHO-DD  
INN   USAN  
Official Name English
NN-9535
Code English
SEMAGLUTIDE [ORANGE BOOK]
Common Name English
NN1535 LAISEMA COMPONENT SEMAGLUTIDE
Common Name English
NN9535
Code English
NNC-0113-0217
Code English
SEMAGLUTIDE [MI]
Common Name English
SEMAGLUTIDE [JAN]
Common Name English
NN1535 ICOSEMA COMPONENT SEMAGLUTIDE
Common Name English
OZEMPIC
Brand Name English
CagriSema component semaglutide
Common Name English
WEGOVY
Brand Name English
Semaglutide [WHO-DD]
Common Name English
NNC 0113-0217
Code English
SEMAGLUTIDE [USAN]
Common Name English
RYBELSUS
Brand Name English
Classification Tree Code System Code
WHO-ATC A10BJ06
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
NCI_THESAURUS C98085
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
NDF-RT N0000178480
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
Code System Code Type Description
DAILYMED
53AXN4NNHX
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
MERCK INDEX
m12052
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
PUBCHEM
56843331
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
SMS_ID
100000124419
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
CAS
910463-68-2
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
RXCUI
1991302
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
DRUG CENTRAL
5267
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
USAN
XX-142
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
EPA CompTox
DTXSID101027903
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
ChEMBL
CHEMBL2108724
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
LACTMED
Semaglutide
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
FDA UNII
53AXN4NNHX
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
DRUG BANK
DB13928
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
EVMPD
SUB32188
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
CHEBI
167574
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
INN
9113
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
WIKIPEDIA
Semaglutide
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
NCI_THESAURUS
C152328
Created by admin on Wed Apr 02 05:28:43 GMT 2025 , Edited by admin on Wed Apr 02 05:28:43 GMT 2025
PRIMARY
Related Record Type Details
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
SEMAGLUTIDE
EXCRETED UNCHANGED
AMOUNT EXCRETED
URINE
Related Record Type Details
SEMAGLUTIDE
ACTIVE MOIETY

Structural Modifications

Modification Type Location Site Location Type Residue Modified Extent Fragment Name Fragment Approval
AMINO_ACID_SUBSTITUTION [1_20] SITE_SPECIFIC LYSINE, SEMAGLUTIDE- 2BRP4PMI4U
AMINO_ACID_SUBSTITUTION [1_2] SITE_SPECIFIC .ALPHA.-AMINOISOBUTYRIC ACID 1E7ZW41IQU
Name Property Type Amount Referenced Substance Defining Parameters References
Molecular Formula CHEMICAL
MOL_WEIGHT:NUMBER(CALCULATED) CHEMICAL
NIH
NCATS
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