Details
Stereochemistry | ACHIRAL |
Molecular Formula | C26H26F3N3O3.2H3O4P |
Molecular Weight | 681.4885 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
OP(O)(O)=O.OP(O)(O)=O.C[C@H]1CN(C[C@@H](C)O1)C2=CC=C(NC(=O)C3=CC=CC(C4=CC=C(OC(F)(F)F)C=C4)=C3C)C=N2
InChI
InChIKey=RWIVSVMMGFFZIJ-VWDRLOGHSA-N
InChI=1S/C26H26F3N3O3.2H3O4P/c1-16-14-32(15-17(2)34-16)24-12-9-20(13-30-24)31-25(33)23-6-4-5-22(18(23)3)19-7-10-21(11-8-19)35-26(27,28)29;2*1-5(2,3)4/h4-13,16-17H,14-15H2,1-3H3,(H,31,33);2*(H3,1,2,3,4)/t16-,17+;;
DescriptionCurator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB09143
Curator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB09143
Sonidegib, also known as LDE225 and marketed as Odomzo, is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was approved by the FDA for treating basal cell carcinoma in July 2015 and is awaiting approval in the EU. The hedgehog pathway is involved in many human cancers. Sonidegib effectively inhibits the regulator called smoothened (Smo), preventing the hedgehog pathway from functioning. As a result, tumours that depend on the hedgehog pathway are unable to grow. Sonidegib is approved for use in the US and EU for treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred post surgery or radiation therapy. It is also approved for adult patients with BCC who are not eligible for surgery or radiation therapy.
Originator
Sources: http://adisinsight.springer.com/drugs/800029270
Curator's Comment: # Novartis
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: Q99835 Gene ID: 6608.0 Gene Symbol: SMO Target Organism: Homo sapiens (Human) Sources: https://www.ncbi.nlm.nih.gov/pubmed/24900187 |
2.5 nM [IC50] | ||
Target ID: CHEMBL5971 Sources: https://www.drugbank.ca/drugs/DB09143 |
2.5 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | ODOMZO Approved UseODOMZO is a hedgehog pathway inhibitor indicated for the treatment of
adult patients with locally advanced basal cell carcinoma (BCC) that has
recurred following surgery or radiation therapy, or those who are not
candidates for surgery or radiation therapy. Launch Date2015 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1030 ng/mL |
200 mg 1 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
SONIDEGIB unknown | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
22 μg × h/mL |
200 mg 1 times / day steady-state, oral dose: 200 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
SONIDEGIB unknown | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1% |
SONIDEGIB plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
3000 mg 1 times / day multiple, oral Highest studied dose Dose: 3000 mg, 1 times / day Route: oral Route: multiple Dose: 3000 mg, 1 times / day Sources: |
unhealthy n = 10 Health Status: unhealthy Population Size: 10 Sources: |
Other AEs: Creatine kinase increased, Rhabdomyolysis... Other AEs: Creatine kinase increased (grade 3-4, 1 patient) Sources: Rhabdomyolysis (3 patients) |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
DLT: Creatine kinase increased... Disc. AE: Muscle spasms, Alopecia... Dose limiting toxicities: Creatine kinase increased (2%) AEs leading todiscontinuation/dose reduction: Muscle spasms (9%) Sources: Page: 104Alopecia (6%) Dysgeusia (5%) Weight decreased (5%) Fatigue (2%) Asthenia (1%) Nausea (4%) Decreased appetite (5%) Arthralgia (1%) Dysphagia (1%) General physical health deterioration (1%) Ageusia (2%) Dehydration (2%) |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 105 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 105 |
Disc. AE: Anemia, Constipation... AEs leading to discontinuation/dose reduction: Anemia (1%) Sources: Page: 105Constipation (1%) Hypertension (1%) Hypogeusia (1%) |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Disc. AE: Diarrhea, Gastroenteritis viral... AEs leading to discontinuation/dose reduction: Diarrhea (5%) Sources: Page: 106Gastroenteritis viral (1%) Rhabdomyolysis (1%) Alanine aminotransferase increased (2%) Aspartate aminotransferase increased (2%) Dizziness (1%) Myalgia (3%) Muscular weakness (1%) Blood uric acid increased (1%) Vomiting (7%) Dyspnea (1%) Myoglobin blood increased (1%) Hypogeusia (1%) Amylase increased (1%) Malaise (1%) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Disc. AE: Amylase increased... AEs leading to discontinuation/dose reduction: Amylase increased (grade 3-4, 1%) Sources: |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Disc. AE: Alanine aminotransferase increased, Aspartate aminotransferase increased... AEs leading to discontinuation/dose reduction: Alanine aminotransferase increased (grade 3-4, 4%) Sources: Aspartate aminotransferase increased (all grades, 19%) Asthenia (4%) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Disc. AE: Muscle spasms, Myalgia... Other AEs: Muscle spasms, Musculoskeletal pain... AEs leading to discontinuation/dose reduction: Muscle spasms (grade 3, 3%) Other AEs:Myalgia (all grades, 19%) Alopecia (all grades, 53%) Diarrhea (grade 3, 1%) Weight decreased (grade 3, 3%) Decreased appetite (grade 3, 1%) Muscle spasms (all grades, 54%) Sources: Musculoskeletal pain (all grades, 32%) Musculoskeletal pain (grade 3, 1%) Pruritus (all grades, 10%) Headache (all grades, 15%) Headache (grade 3, 1%) Fatigue (all grades, 41%) Pain (all grades, 14%) Pain (grade 3, 1%) Nausea (all grades, 39%) Diarrhea (all grades, 32%) Abdominal pain (all grades, 18%) Vomiting (all grades, 11%) Weight decreased (all grades, 30%) Decreased appetite (all grades, 23%) Increased serum creatinine (all grades, 92%) Creatine kinase increased (all grades, 61%) Hyperglycemia (all grades, 51%) Hyperglycemia (grade 3-4, 4%) Lipase increased (all grades, 43%) Alanine aminotransferase increased (all grades, 19%) Aspartate aminotransferase increased (grade 3-4, 4%) Amylase increased (all grades, 16%) Anemia (all grades, 32%) Lymphopenia (all grades, 28%) Lymphopenia (grade 3-4, 3%) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Disc. AE: Dysgeusia, Fatigue... AEs leading to discontinuation/dose reduction: Dysgeusia (all grades, 46%) Sources: Fatigue (grade 3, 4%) Nausea (grade 3, 1%) Vomiting (grade 3, 1%) Creatine kinase increased (grade 3-4, 8%) Lipase increased (grade 3-4, 13%) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Disc. AE: Arthralgia, Dysphagia... AEs leading to discontinuation/dose reduction: Arthralgia (1 patient) Sources: Page: 104Dysphagia (1 patient) General physical health deterioration (1 patient) Abdominal pain upper (1 patient) Agitation (1 patient) Depression (1 patient) Dry mouth (1 patient) Lumbar vertebral fracture (1 patient) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 106 |
Disc. AE: Rhabdomyolysis, Dizziness... AEs leading to discontinuation/dose reduction: Rhabdomyolysis (1%) Sources: Page: 106Dizziness (1%) Pneumonia (1%) Muscular weakness (1%) |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Disc. AE: Blood uric acid increased, Angina pectoris... AEs leading to discontinuation/dose reduction: Blood uric acid increased (1%) Sources: Page: 107Angina pectoris (1%) Anorectal infection (1%) Back pain (1%) Bile duct stone (1%) Cough (1%) Disturbance in attention (1%) Femoral neck fracture (1%) Gastric ulcer (1%) Influenza (1%) Sleep disorder (1%) Spinal compression fracture (1%) Upper respiratory tract infection (1%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Rhabdomyolysis | 3 patients | 3000 mg 1 times / day multiple, oral Highest studied dose Dose: 3000 mg, 1 times / day Route: oral Route: multiple Dose: 3000 mg, 1 times / day Sources: |
unhealthy n = 10 Health Status: unhealthy Population Size: 10 Sources: |
Creatine kinase increased | grade 3-4, 1 patient | 3000 mg 1 times / day multiple, oral Highest studied dose Dose: 3000 mg, 1 times / day Route: oral Route: multiple Dose: 3000 mg, 1 times / day Sources: |
unhealthy n = 10 Health Status: unhealthy Population Size: 10 Sources: |
Arthralgia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Asthenia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Dysphagia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
General physical health deterioration | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Creatine kinase increased | 2% DLT, Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Ageusia | 2% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Dehydration | 2% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Fatigue | 2% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Nausea | 4% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Decreased appetite | 5% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Dysgeusia | 5% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Weight decreased | 5% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Alopecia | 6% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Muscle spasms | 9% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 104 |
Anemia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 105 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 105 |
Constipation | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 105 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 105 |
Hypertension | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 105 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 105 |
Hypogeusia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 105 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 105 |
Amylase increased | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Blood uric acid increased | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Dizziness | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Dyspnea | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Gastroenteritis viral | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Hypogeusia | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Malaise | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Muscular weakness | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Myoglobin blood increased | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Rhabdomyolysis | 1% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Alanine aminotransferase increased | 2% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Aspartate aminotransferase increased | 2% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Myalgia | 3% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Diarrhea | 5% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Vomiting | 7% Disc. AE |
800 mg 1 times / day steady, oral MTD Dose: 800 mg, 1 times / day Route: oral Route: steady Dose: 800 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 150 Health Status: unhealthy Population Size: 150 Sources: Page: 106 |
Amylase increased | grade 3-4, 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Asthenia | 4% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Aspartate aminotransferase increased | all grades, 19% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Alanine aminotransferase increased | grade 3-4, 4% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Pruritus | all grades, 10% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Vomiting | all grades, 11% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Pain | all grades, 14% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Headache | all grades, 15% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Amylase increased | all grades, 16% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Abdominal pain | all grades, 18% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Alanine aminotransferase increased | all grades, 19% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Myalgia | all grades, 19% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Decreased appetite | all grades, 23% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Lymphopenia | all grades, 28% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Weight decreased | all grades, 30% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Anemia | all grades, 32% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Diarrhea | all grades, 32% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Musculoskeletal pain | all grades, 32% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Nausea | all grades, 39% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Fatigue | all grades, 41% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Lipase increased | all grades, 43% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Hyperglycemia | all grades, 51% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Alopecia | all grades, 53% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Muscle spasms | all grades, 54% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Creatine kinase increased | all grades, 61% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Increased serum creatinine | all grades, 92% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Headache | grade 3, 1% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Musculoskeletal pain | grade 3, 1% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Pain | grade 3, 1% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Decreased appetite | grade 3, 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Diarrhea | grade 3, 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Muscle spasms | grade 3, 3% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Weight decreased | grade 3, 3% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Lymphopenia | grade 3-4, 3% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Aspartate aminotransferase increased | grade 3-4, 4% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Hyperglycemia | grade 3-4, 4% | 200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Dysgeusia | all grades, 46% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Nausea | grade 3, 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Vomiting | grade 3, 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Fatigue | grade 3, 4% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Lipase increased | grade 3-4, 13% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Creatine kinase increased | grade 3-4, 8% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: |
Abdominal pain upper | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Agitation | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Arthralgia | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Depression | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Dry mouth | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Dysphagia | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
General physical health deterioration | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Lumbar vertebral fracture | 1 patient Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 104 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 104 |
Dizziness | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 106 |
Muscular weakness | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 106 |
Pneumonia | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 106 |
Rhabdomyolysis | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 106 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 106 |
Angina pectoris | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Anorectal infection | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Back pain | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Bile duct stone | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Blood uric acid increased | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Cough | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Disturbance in attention | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Femoral neck fracture | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Gastric ulcer | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Influenza | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Sleep disorder | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Spinal compression fracture | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Upper respiratory tract infection | 1% Disc. AE |
200 mg 1 times / day steady, oral Recommended Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: Page: 107 |
unhealthy n = 79 Health Status: unhealthy Condition: locally advanced BCC Population Size: 79 Sources: Page: 107 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
yes [IC50 1.5 uM] | ||||
yes [Ki 0.045 uM] | unknown (co-administration study) Comment: study to assess the effects of sonidegib on the PK of a CYP2B6 and a CYP2C9 probe substrate is ongoing Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205266Orig1s000ClinPharmR.pdf#page=7 Page: - |
|||
yes [Ki 1.7 uM] | unknown (co-administration study) Comment: study to assess the effects of sonidegib on the PK of a CYP2B6 and a CYP2C9 probe substrate is ongoing Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205266Orig1s000ClinPharmR.pdf#page=7 Page: - |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major | yes (co-administration study) Comment: Sonidegib is metabolized by CYP3A4 to several inactive metabolites. Ketoconazole increased sonidegib AUC0-10d by 2.2-fold and rifampicin decreased sonidegib AUC0-10d by 72% following a single 800 mg dose in healthy subjects. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205266Orig1s000ClinPharmR.pdf#page=7 Page: - |
|||
no | ||||
no | ||||
no |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
PubMed
Title | Date | PubMed |
---|---|---|
Discovery of NVP-LDE225, a Potent and Selective Smoothened Antagonist. | 2010 Jun 10 |
|
Identification of a novel Smoothened antagonist that potently suppresses Hedgehog signaling. | 2012 Nov 15 |
|
Epigenetic targeting of Hedgehog pathway transcriptional output through BET bromodomain inhibition. | 2014 Jul |
Patents
Sample Use Guides
Recommended dose: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/24900187
Sonidegib inhibits TM3 luciferized cell line with 0.6 nM and 8 nM, at the presence of 1 nM and 25 nM Hh agonist Ag1.5, respectively.
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Classification Tree | Code System | Code | ||
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EMA ASSESSMENT REPORTS |
ODOMZO (AUTHORISED: CARCINOMA, BASAL CELL)
Created by
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NCI_THESAURUS |
C2189
Created by
admin on Sat Dec 16 11:00:30 GMT 2023 , Edited by admin on Sat Dec 16 11:00:30 GMT 2023
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Code System | Code | Type | Description | ||
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1659192
Created by
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PRIMARY | RxNorm | ||
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W421AI34UW
Created by
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PRIMARY | |||
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C152405
Created by
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PRIMARY | |||
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BC-13
Created by
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PRIMARY | |||
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DBSALT001253
Created by
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PRIMARY | |||
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W421AI34UW
Created by
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PRIMARY | |||
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EU/3/09/697 (POSITIVE)
Created by
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PRIMARY | |||
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1218778-77-8
Created by
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PRIMARY | |||
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100000157774
Created by
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PRIMARY | |||
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45138699
Created by
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PRIMARY | |||
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90864
Created by
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PRIMARY | |||
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CHEMBL2105737
Created by
admin on Sat Dec 16 11:00:30 GMT 2023 , Edited by admin on Sat Dec 16 11:00:30 GMT 2023
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PRIMARY | |||
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DTXSID90669468
Created by
admin on Sat Dec 16 11:00:30 GMT 2023 , Edited by admin on Sat Dec 16 11:00:30 GMT 2023
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PRIMARY | |||
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m11843
Created by
admin on Sat Dec 16 11:00:30 GMT 2023 , Edited by admin on Sat Dec 16 11:00:30 GMT 2023
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PRIMARY | |||
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SUB166283
Created by
admin on Sat Dec 16 11:00:30 GMT 2023 , Edited by admin on Sat Dec 16 11:00:30 GMT 2023
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PRIMARY |
ACTIVE MOIETY
SUBSTANCE RECORD