Details
| Stereochemistry | ABSOLUTE |
| Molecular Formula | C49H54N8O8 |
| Molecular Weight | 883.0019 |
| Optical Activity | UNSPECIFIED |
| Defined Stereocenters | 6 / 6 |
| E/Z Centers | 0 |
| Charge | 0 |
SHOW SMILES / InChI
SMILES
COC[C@H]1C[C@H](N(C1)C(=O)[C@H](NC(=O)OC)C2=CC=CC=C2)C3=NC=C(N3)C4=CC=C5C(COC6=CC7=C(C=CC8=C7NC(=N8)[C@@H]9CC[C@H](C)N9C(=O)[C@@H](NC(=O)OC)C(C)C)C=C56)=C4
InChI
InChIKey=FHCUMDQMBHQXKK-CDIODLITSA-N
InChI=1S/C49H54N8O8/c1-26(2)41(54-48(60)63-5)47(59)57-27(3)12-17-38(57)45-51-36-16-14-30-20-35-33-15-13-31(19-32(33)25-65-40(35)21-34(30)43(36)53-45)37-22-50-44(52-37)39-18-28(24-62-4)23-56(39)46(58)42(55-49(61)64-6)29-10-8-7-9-11-29/h7-11,13-16,19-22,26-28,38-39,41-42H,12,17-18,23-25H2,1-6H3,(H,50,52)(H,51,53)(H,54,60)(H,55,61)/t27-,28-,38-,39-,41-,42+/m0/s1
Velpatasvir (VEL; GS-5816) is an inhibitor of HCV NS5A protein, it demonstrated favourable in vitro and in vivo properties, including potent antiviral activity against hepatitis C virus genotypes 1 to 6 replicon, good metabolic stability, low systemic clearance, and adequate bioavailability and physicochemical properties to warrant clinical evaluation. Velpatasvir is used together with sofosbuvir in the treatment of hepatitis C infection of all six major genotypes. A once-daily, single-tablet, pangenotypic regimen comprising
the HCV NS5B polymerase inhibitor sofosbuvir and
the HCV NS5A inhibitor velpatasvir (sofosbuvir/
velpatasvir; Epclusa) has recently been approved for the
treatment of adults with chronic HCV genotype 1, 2, 3, 4, 5
or 6 infection in the USA, EU and Canada.
Originator
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
| 0.014 nM [EC50] |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Primary | Epclusa Approved UseEPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C
virus (HCV) nucleotide analog NS5B polymerase inhibitor, and
velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment
of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection. Launch Date2016 |
Cmax
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
28.3 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
411 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg 1 times / day multiple, oral dose: 50 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
669 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
1200 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg 1 times / day multiple, oral dose: 450 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
22.4 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
371 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
398 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
|
608 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
575 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
800 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: LOW-FAT |
|
1120 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg single, oral dose: 450 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
AUC
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
172 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
3030 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg 1 times / day multiple, oral dose: 50 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
4890 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
9510 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg 1 times / day multiple, oral dose: 450 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
159 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
3020 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
3620 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
|
4980 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
5060 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
7120 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: LOW-FAT |
|
9580 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg single, oral dose: 450 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
T1/2
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
13.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
13 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg 1 times / day multiple, oral dose: 50 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
15.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
11.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg 1 times / day multiple, oral dose: 450 mg route of administration: Oral experiment type: MULTIPLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
11.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
13.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
14.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
|
16.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
15.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
16.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: LOW-FAT |
|
15 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
450 mg single, oral dose: 450 mg route of administration: Oral experiment type: SINGLE co-administered: |
VELPATASVIR plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
Funbound
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
0.3% EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28193657 |
unknown, unknown |
VELPATASVIR plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
| Dose | Population | Adverse events |
|---|---|---|
150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
Disc. AE: Nausea... Other AEs: Headache, Nausea... AEs leading to discontinuation/dose reduction: Nausea (3.2%) Other AEs:Headache (12.9%) Sources: Nausea (6.5%) Vomiting (6.5%) Cough (3.2%) Hypertension (3.2%) |
AEs
| AE | Significance | Dose | Population |
|---|---|---|---|
| Headache | 12.9% | 150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
| Cough | 3.2% | 150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
| Hypertension | 3.2% | 150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
| Nausea | 3.2% Disc. AE |
150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
| Nausea | 6.5% | 150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
| Vomiting | 6.5% | 150 mg 1 times / day multiple, oral Highest studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy, 49 years (range: 28–63 years) n = 31 Health Status: unhealthy Condition: genotype 1–4 hepatitis C virus Age Group: 49 years (range: 28–63 years) Sex: M+F Population Size: 31 Sources: |
Sample Use Guides
Recommended dosage: One tablet (400 mg of sofosbuvir and
100 mg of velpatasvir) taken orally once daily with or without food
Route of Administration:
Oral
Velpatasvir had mean EC50
values of 0.014, 0.016, 0.005–0.016, 0.002–0.006, 0.004,
0.009, 0.004, 0.021–0.054, 0.006–0.009 and 0.130 nmol/L
against laboratory replicons with HCV genotypes 1a, 1b,
2a, 2b, 3a, 4a, 4d, 5a, 6a and 6e, respectively, and median
EC50 values of 0.002–0.024 nmol/L against replicons
containing NS5A from clinical isolates with HCV genotypes
1a, 1b, 2a, 2b, 3a, 4a, 4d, 4r, 5a, 6a and 6e.
| Name | Type | Language | ||
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Common Name | English | ||
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Code | English |
| Classification Tree | Code System | Code | ||
|---|---|---|---|---|
|
NCI_THESAURUS |
C281
Created by
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WHO-ATC |
J05AP56
Created by
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NDF-RT |
N0000191256
Created by
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FDA ORPHAN DRUG |
554816
Created by
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NCI_THESAURUS |
C783
Created by
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WHO-ATC |
J05AP55
Created by
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| Code System | Code | Type | Description | ||
|---|---|---|---|---|---|
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Velpatasvir
Created by
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PRIMARY | |||
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100000166177
Created by
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PRIMARY | |||
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N0000190107
Created by
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PRIMARY | Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA] | ||
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5154
Created by
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PRIMARY | |||
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KCU0C7RS7Z
Created by
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PRIMARY | |||
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N0000190108
Created by
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PRIMARY | Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA] | ||
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1377049-84-7
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PRIMARY | |||
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CHEMBL3545062
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PRIMARY | |||
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N0000190113
Created by
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PRIMARY | Breast Cancer Resistance Protein Inhibitors [MoA] | ||
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1799206
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PRIMARY | |||
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N0000190109
Created by
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PRIMARY | Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA] | ||
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Velpatasvir
Created by
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PRIMARY | |||
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133009
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PRIMARY | |||
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N0000185503
Created by
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PRIMARY | P-Glycoprotein Inhibitors [MoA] | ||
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CD-110
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m11941
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PRIMARY | |||
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67683363
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PRIMARY | |||
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KCU0C7RS7Z
Created by
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PRIMARY | |||
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C152851
Created by
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PRIMARY | |||
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9960
Created by
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PRIMARY | |||
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DB11613
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PRIMARY | |||
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SUB180213
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DTXSID70722565
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PRIMARY |
ACTIVE MOIETY
METABOLITE (PARENT)
