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

Details

Stereochemistry ABSOLUTE
Molecular Formula C15H28N4O4.3H2O
Molecular Weight 382.4531
Optical Activity UNSPECIFIED
Defined Stereocenters 5 / 5
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of PERAMIVIR

SMILES

O.O.O.[H][C@@]1([C@@H](NC(C)=O)C(CC)CC)[C@H](O)[C@H](C[C@H]1NC(N)=N)C(O)=O

InChI

InChIKey=RFUCJKFZFXNIGB-ZBBHRWOZSA-N
InChI=1S/C15H28N4O4.3H2O/c1-4-8(5-2)12(18-7(3)20)11-10(19-15(16)17)6-9(13(11)21)14(22)23;;;/h8-13,21H,4-6H2,1-3H3,(H,18,20)(H,22,23)(H4,16,17,19);3*1H2/t9-,10+,11+,12-,13+;;;/m0.../s1

HIDE SMILES / InChI
Molecular Formula H2O
Molecular Weight 18.0153
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE
Molecular Formula C15H28N4O4
Molecular Weight 328.4072
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 4 / 5
E/Z Centers 0
Optical Activity UNSPECIFIED

Description
Curator's Comment: description was created based on several sources, including https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fdedaec-9e53-4a37-a4e4-a301c8a251b8; http://www.rxlist.com/script/main/art.asp?articlekey=185939

Peramivir is a transition-state analogue and a potent, specific influenza viral neuraminidase inhibitor. Rapivab (peramivir injection) is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days. Efficacy of Rapivab is based on clinical trials in which the predominant influenza virus type was influenza A and a limited number of subjects infected with influenza B virus were enrolled. Since influenza viruses change over time emergence of resistance substitutions could decrease drug effectiveness. Other factors such as changes in viral virulence might also diminish clinical benefit of antiviral drug. Efficacy could not be established in patients with serious influenza requiring hospitalization.

Originator

Approval Year

2014
494
Targets

Targets

Primary TargetPharmacologyConditionPotency
UNIPROT: O91745 (Neuraminidase)
3
Target ID: UNIPROT: O91745 (Neuraminidase)
Inhibitor
8297
 0.08 nM [IC50]
Inhibitor
8297
 0.22 nM [EC50]
Inhibitor
8297
 0.045 nM [EC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
RAPIVAB

Approved Use

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than 2 days.

Launch Date

2014
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
46800 ng/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
600 mg single, intravenous
dose: 600 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PERAMIVIR ANHYDROUS serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
102700 ng × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
600 mg single, intravenous
dose: 600 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PERAMIVIR ANHYDROUS serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
20 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
600 mg single, intravenous
dose: 600 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PERAMIVIR ANHYDROUS serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
70%
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
600 mg single, intravenous
dose: 600 mg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PERAMIVIR ANHYDROUS serum
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Other AEs: Leukopenia, Neutropenia...
Other AEs:
Leukopenia (42.9%)
Neutropenia (14.3%)
Hyperglycemia (42.9%)
Hypertension (28.6%)
AST increased (14.3%)
ALT increased (14.3%)
Diarrhea (14.3%)
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
400 mg 2 times / day multiple, intravenous
Highest studied dose
Dose: 400 mg, 2 times / day
Route: intravenous
Route: multiple
Dose: 400 mg, 2 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
400 mg 2 times / day multiple, intravenous
Highest studied dose
Dose: 400 mg, 2 times / day
Route: intravenous
Route: multiple
Dose: 400 mg, 2 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
600 mg 1 times / day multiple, intramuscular
Highest studied dose
Dose: 600 mg, 1 times / day
Route: intramuscular
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 60
healthy, adult
Health Status: healthy
Age Group: adult
Sex: unknown
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 60
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 60
800 mg 1 times / day multiple, intravenous
Highest studied dose
Dose: 800 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 800 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
Sources:
https://pubmed.ncbi.nlm.nih.gov/27805571/
800 mg 1 times / day multiple, intravenous
Highest studied dose
Dose: 800 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 800 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
healthy, adult
Health Status: healthy
Age Group: adult
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
Sources:
https://pubmed.ncbi.nlm.nih.gov/27317305/
300 mg 1 times / day multiple, intravenous
Minumum effective dose
Dose: 300 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 363
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 363
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Disc. AE: Lymphadenopathy, Gingival pain...
AEs leading to
discontinuation/dose reduction:
Lymphadenopathy (<1%)
Gingival pain (<1%)
Salivary gland pain (<1%)
Rash (<1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 654
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 654
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Other AEs: Alanine aminotransferase, Creatine phosphokinase...
Other AEs:
Alanine aminotransferase (grade 2-4, 3%)
Creatine phosphokinase (grade 2-4, 4%)
Neutrophils (grade 2-4, 8%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 660
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 660
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Other AEs: Serum glucose...
Other AEs:
Serum glucose (grade 2-4, 5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Disc. AE: Abdominal pain upper, Arthralgia...
AEs leading to
discontinuation/dose reduction:
Abdominal pain upper (<1%)
Arthralgia (<1%)
Drug eruption (<1%)
Eczema (<1%)
Rash (<1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
AEs

AEs

AESignificanceDosePopulation
ALT increased 14.3%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
AST increased 14.3%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Diarrhea 14.3%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Neutropenia 14.3%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Hypertension 28.6%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Hyperglycemia 42.9%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Leukopenia 42.9%
11.4 mg/kg 1 times / day steady, intravenous (median)
Dose: 11.4 mg/kg, 1 times / day
Route: intravenous
Route: steady
Dose: 11.4 mg/kg, 1 times / day
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
unhealthy, 2.4-9.8 years
n = 7
Health Status: unhealthy
Condition: H1N1
Age Group: 2.4-9.8 years
Sex: M+F
Population Size: 7
Sources:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6836703/
Page: 500
Gingival pain <1%
Disc. AE
300 mg 1 times / day multiple, intravenous
Minumum effective dose
Dose: 300 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 363
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 363
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Lymphadenopathy <1%
Disc. AE
300 mg 1 times / day multiple, intravenous
Minumum effective dose
Dose: 300 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 363
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 363
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Rash <1%
Disc. AE
300 mg 1 times / day multiple, intravenous
Minumum effective dose
Dose: 300 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 363
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 363
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Salivary gland pain <1%
Disc. AE
300 mg 1 times / day multiple, intravenous
Minumum effective dose
Dose: 300 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 300 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 363
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 363
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Alanine aminotransferase grade 2-4, 3%
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 654
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 654
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Creatine phosphokinase grade 2-4, 4%
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 654
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 654
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Neutrophils grade 2-4, 8%
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 654
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 654
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Serum glucose grade 2-4, 5%
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
unhealthy, adult
n = 660
Health Status: unhealthy
Condition: H1N1
Age Group: adult
Sex: unknown
Population Size: 660
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206426lbl.pdf
Page: 4
Abdominal pain upper <1%
Disc. AE
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Arthralgia <1%
Disc. AE
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Drug eruption <1%
Disc. AE
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Eczema <1%
Disc. AE
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Rash <1%
Disc. AE
600 mg 1 times / day multiple, intravenous
Recommended
Dose: 600 mg, 1 times / day
Route: intravenous
Route: multiple
Dose: 600 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
unhealthy, adult
n = 365
Health Status: unhealthy
Condition: acute uncomplicated influenza
Age Group: adult
Sex: unknown
Population Size: 365
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206426Orig1s000ClinPharmR.pdf
Page: 98
Sourcing

Sourcing

Vendor/AggregatorIDURL
AA Blocks
AA00C6EE
https://www.aablocks.com/goods/Goods/detail?id=AA00C6EE
AK Scientific, Inc. (AKSCI)
66630
http://www.aksci.com/item_detail.php?cat=66630
Achemtek
0102-014544
http://www.achemtek.com/330600-85-6
Acorn PharmaTech
ACN-028788
http://www.acornpharmatech.com/
Active Biopharma
ABP000969
http://www.activebiopharma.com/229614-55-5
Adooq BioScience
A11124
https://www.adooq.com/peramivir.html
Alsachim
2957
http://www.alsachim.com/product-C4029-glo.bal-view.html
ApexBio Technology
A3709
http://www.apexbt.com/peramivir-20402.html
AstaTech, Inc.
67953
http://www.astatechinc.com/CPSResult.php?CRNO=14007
Aurora Fine Chemicals LLC
A13.110.340
http://online.aurorafinechemicals.com/info?ID=A13.110.340
AvaChem Scientific
3036
http://www.avachem.com/productSearch.asp?3036
BLD Pharm
BD147150
http://www.bldpharm.com/products/330600-85-6.html
BioCrick
BCC1846
http://www.biocrick.com/Peramivir-BCC1846.html
Chem Scene
CS-0638
http://www.chemscene.com/330600-85-6.html
ChemMol
30115938
http://www.chemmol.com/chemmol/30115938.html
ChemMol
99063194
http://www.chemmol.com/chemmol/99063194.html
Chemspace
CSSB00016988245
https://chem-space.com/CSSB00016988245
DC Chemicals
DCAPI1121
http://www.dcchemicals.com//product_show-Peramivir.html
Hairui
HR118227
http://www.hairuichem.com/en/product/229614-55-5.html
Lab Network
LN00199254
https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN00199254
Matrix Scientific
97285
https://www.matrixscientific.com/097285.html
MedChem Express
HY-17015A
https://www.medchemexpress.com/peramivir.html
MuseChem
I012304
https://www.musechem.com/product/I012304.html
OChem
26458
http://www.ocheminc.com/index.php?act=psearch&pid=600P856
Oakwood
234978
http://www.oakwoodchemical.com/ProductsList.aspx?CategoryID=-2&txtSearch=115977&ExtHyperLink=1
Renno Tech
RL02720
http://www.rennotech.com/product_show.asp?id=2969
Renno Tech
RL03191
http://www.rennotech.com/product_show.asp?id=3440
Smolecule
S006020
http://www.smolecule.com/products/s006020
Smolecule
S539024
http://www.smolecule.com/products/s539024
Smolecule
S794776
https://www.smolecule.com/products/s794776
THE BioTek
bt-255076
https://www.thebiotek.com/product/inhibitors/bt-255076
THE BioTek
bt-279105
https://www.thebiotek.com/product/inhibitors/bt-279105
THE BioTek
bt-429681
https://www.thebiotek.com/product/others/bt-429681
THE BioTek
bt-459453
https://www.thebiotek.com/product/others/bt-459453
TripleBond
CP0131
http://www.triplebond-canada.com/prod/1542/
abcr GmbH
AB459983
http://www.abcr.com/shop/en/AB459983
eNovation Chemicals
D486401
https://www.enovationchem.com/ProductDetails.asp?ProductID=D486401
eNovation Chemicals
D514547
https://www.enovationchem.com/ProductDetails.asp?ProductID=D514547
eNovation Chemicals
D679637
https://www.enovationchem.com/ProductDetails.asp?ProductID=D679637
eNovation Chemicals
Y0974045
https://www.enovationchem.com/ProductDetails.asp?ProductID=Y0974045
eNovation Chemicals
Y0986882
https://www.enovationchem.com/ProductDetails.asp?ProductID=Y0986882
PubMed

PubMed

TitleDatePubMed
BCX-1812 (RWJ-270201): discovery of a novel, highly potent, orally active, and selective influenza neuraminidase inhibitor through structure-based drug design.
2000 Sep 21
Comparison of the anti-influenza virus activity of RWJ-270201 with those of oseltamivir and zanamivir.
2001 Apr
Primary immune system effects of the orally administered cyclopentane neuraminidase inhibitor RWJ-270201 in influenza virus-infected mice.
2001 Jun
In vitro characterization of A-315675, a highly potent inhibitor of A and B strain influenza virus neuraminidases and influenza virus replication.
2002 Apr
Peramivir (BCX-1812, RWJ-270201): potential new therapy for influenza.
2002 Jun
Combination treatment of influenza A virus infections in cell culture and in mice with the cyclopentane neuraminidase inhibitor RWJ-270201 and ribavirin.
2002 May
Structural studies of the resistance of influenza virus neuramindase to inhibitors.
2002 May 23
Comparison of colorimetric, fluorometric, and visual methods for determining anti-influenza (H1N1 and H3N2) virus activities and toxicities of compounds.
2002 Oct
Inhibition of influenza virus infections in immunosuppressed mice with orally administered peramivir (BCX-1812).
2003 Sep
A QSAR study on influenza neuraminidase inhibitors.
2006 Feb 15
Patents

Patents

20130165400
6
US2007244193
3
US2011065795
3

Sample Use Guides

In Vivo Use Guide
The recommended dose of RAPIVAB in adult patients 18 years of age or older with acute uncomplicated influenza is a single 600 mg dose, administered via intravenous infusion for 15 to 30 minutes. The dose should be reduced for patients with baseline creatinine clearance below 50 mL/min to 200 mg dose (at 30-49 mL/min creatinine clearance), and 100 mg dose (at 10-29 mL/min creatinine clearance).
Route of Administration: Intravenous
In Vitro Use Guide
The concentrations of peramivir required for inhibition of influenza virus in cell culture varied with the virus strain tested. The effect of antiviral compounds on the replication of influenza viruses in MDCK cells was determined by flow cytometric analysis of virus-infected cells. The mean 50% effective concentrations (EC50 values) of peramivir were in the range of 0.045-0.071 nM), 0.065-0.07 nM and 0.215-33.58 nM for influenza A/H1N1 virus, A/H3N2 virus, and B virus strains, respectively.
Substance Class Chemical
Created
by admin
on Fri Dec 15 15:30:36 GMT 2023
Edited
by admin
on Fri Dec 15 15:30:36 GMT 2023
Record UNII
QW7Y7ZR15U
Record Status Validated (UNII)
Record Version
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Name Type Language
PERAMIVIR
DASH   MART.   USAN   VANDF   WHO-DD  
USAN  
Official Name English
Peramivir [WHO-DD]
Common Name English
PERAMIVIR [MART.]
Common Name English
RAPIVAB
Brand Name English
BCX-1812
Code English
PERAMIVIR [USAN]
Common Name English
PERAMIVIR TRIHYDRATE [MI]
Common Name English
RAPIACTA
Brand Name English
Peramivir trihydrate [WHO-DD]
Common Name English
CYCLOPENTANECARBOXYLIC ACID, 3-((1S)-1-(ACETYLAMINO)-2-ETHYLBUTYL)-4-((AMINOIMINOMETHYL)AMINO)-2-HYDROXY-, (1S,2S,3R,4R)-
Common Name English
PERAMIVIR TRIHYDRATE
MI  
Common Name English
(1S,2S,3R,4R)-3-((1S)-1-ACETYLAMINO-2-ETHYLBUTYL)-4-((AMINOIMINOMETHYL)AMINO)-2-HYDROXYCYCLOPENTANECARBOXYLIC ACID, TRIHYDRATE
Common Name English
PERAMIVIR HYDRATE
JAN  
Common Name English
CYCLOPENTANECARBOXYLIC ACID, 3-((1S)-1-(ACETYLAMINO)-2-ETHYLBUTYL)-4-((AMINOIMINOMETHYL)AMINO)-2-HYDROXY-, HYDRATE (1:3), (1S,2S,3R,4R)-
Common Name English
(1S,2S,3R,4R)-3-((1S)-1-ACETAMIDO-2-ETHYLBUTYL)-4-((AMINO(IMINO)METHYL)AMINO)-2-HYDROXYCYCLOPENTANECARBOXYLIC ACID TRIHYDRATE
Systematic Name English
PERAMIVIR [ORANGE BOOK]
Common Name English
PERAMIVIR [VANDF]
Common Name English
PERAMIVIR HYDRATE [JAN]
Common Name English
Classification Tree Code System Code
WHO-ATC J05AH03
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
NCI_THESAURUS C281
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
NDF-RT N0000175524
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
Code System Code Type Description
FDA UNII
QW7Y7ZR15U
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
RXCUI
619693
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY RxNorm
DAILYMED
QW7Y7ZR15U
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
CAS
1041434-82-5
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
LACTMED
Peramivir
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
PUBCHEM
11954371
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
EPA CompTox
DTXSID60146317
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
CHEBI
85196
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
ChEMBL
CHEMBL139367
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
USAN
WW-64
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
DRUG BANK
DB06614
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
DRUG CENTRAL
4823
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
MESH
C414210
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
CHEBI
85202
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
JAPANESE REVIEW
RAPIACTA
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY APPROVED JANUARY 2010
NCI_THESAURUS
C81611
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
SMS_ID
100000124542
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY
MERCK INDEX
m8534
Created by admin on Fri Dec 15 15:30:36 GMT 2023 , Edited by admin on Fri Dec 15 15:30:36 GMT 2023
PRIMARY Merck Index
Related Record Type Details
INFLUENZA B VIRUS WHOLE
TARGET ORGANISM->INHIBITOR
Structure of PERAMIVIR ANHYDROUS
ANHYDROUS->SOLVATE
INFLUENZA A VIRUS WHOLE
TARGET ORGANISM->INHIBITOR
Structure of PERAMIVIR ANHYDROUS
PARENT -> SALT/SOLVATE
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
Related Record Type Details
Structure of PERAMIVIR ANHYDROUS
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Biological Half-life PHARMACOKINETIC
Volume of Distribution PHARMACOKINETIC
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
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