> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/velpatasvir-356a56b3-13b5-463b-83d6-6418568ca39a
> Record changed: 2026-11-04

# Velpatasvir

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

First approval year

2016

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

## Development status

**First approval year**

2016

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**Drug name**

Velpatasvir

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**Molecular weight**

883.02

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**Structure (SMILES)**

COC\[C@H\]1C\[C@@H\](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc(\[C@@H\]7CC\[C@H\](C)N7C(=O)\[C@@H\](NC(=O)OC)C(C)C)\[nH\]c65)cc3-4)c\[nH\]2)N(C(=O)\[C@H\](NC(=O)OC)c2ccccc2)C1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

### Brand names (4)

- velpatasvir component of epclusa
- Velpatasvir component of epclusa
- velpatasvir component of vosevi
- Velpatasvir component of vosevi

### Other names (32)

- epclusa component velpatasvir
- EPCLUSA COMPONENT VELPATASVIR
- gs 5816
- GS-5816
- sofosbuvir and velpatasvir
- sofosbuvir sof gs 5816
- sofosbuvir velpatasvir
- sofosbuvir velpatasvir 400 mg 100 mg oral tablet
- sofosbuvir velpatasvir epclusa
- sofosbuvir velpatasvir gilead
- sofosbuvir velpatasvir oral tablet
- sofosbuvir velpatasvir ribavirin
- sofosbuvir velpatasvir tablet
- sofosbuvir velpatasvir voxilaprevir
- velpatasvir
- Velpatasvir
- velpatasvir \[INN\]
- VELPATASVIR \[JAN\]
- VELPATASVIR \[MI\]
- VELPATASVIR \[ORANGE BOOK\]
- VELPATASVIR \[USAN\]
- Velpatasvir \[WHO-DD\]
- velpatasvir 100mg
- velpatasvir inn
- velpatasvir jan

And 7 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 1377049-84-7

**ChEMBL ID**

CHEMBL3545062

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**InChIKey**

FHCUMDQMBHQXKK-CDIODLITSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3545062)

**PubChem compound IDs**

- 67683363

**RxNorm IDs (RxCUI)**

- 1799206

**FDA ingredient codes (UNII)**

- KCU0C7RS7Z

## Regulatory information

### United States

**Applicant**

GILEAD SCIENCES INC

**Approval date**

28 Jun 2016

**Application number**

NDA208341

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**Pharmacology name**

velpatasvir

**Type**

Synthetic organic

**Drug name stem**

\-vir

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action

- **Mechanism**  
Nonstructural protein 5A inhibitor

**Action type**  
Inhibitor

**Target**  
Nonstructural protein 5A

**Protein identifier**  
Q5L478

### Open Targets mechanisms

- **Mechanism**  
Nonstructural protein 5A inhibitor

**Action type**  
Inhibitor

**Target**  
Nonstructural protein 5A

### DrugCentral mechanisms (8)

- **Action type**  
Inhibitor

**Protein identifier**  
O39929

**Organism**  
Hepatitis C virus genotype 4a (isolate ED43)
- **Action type**  
Inhibitor

**Protein identifier**  
O91936

**Organism**  
Hepatitis C virus genotype 5a (isolate SA13) (HCV)
- **Action type**  
Inhibitor

**Protein identifier**  
P26663

**Organism**  
Hepatitis C virus genotype 1b (isolate BK)
- **Action type**  
Inhibitor

**Protein identifier**  
P27958

**Organism**  
Hepatitis C virus genotype 1a (isolate H)
- **Action type**  
Inhibitor

**Protein identifier**  
Q5I2N3

**Organism**  
Hepatitis C virus genotype 6a (isolate 6a33) (HCV)
- **Action type**  
Inhibitor

**Protein identifier**  
Q81495

**Organism**  
Hepatitis C virus genotype 3a (isolate k3a) (HCV)
- **Action type**  
Inhibitor

**Protein identifier**  
Q99IB8

**Organism**  
Hepatitis C virus genotype 2a (isolate JFH-1)
- **Action type**  
Inhibitor

**Protein identifier**  
Q9DHD6

**Organism**  
Hepatitis C virus genotype 2b (isolate JPUT971017) (HCV)

### Investigated indications (2)

- **Condition**  
Hepatitis C

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003047

**Subject identifier**  
D006526
- **Condition**  
Hepatitis C, Chronic

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0004220

**Subject identifier**  
D019698

### Open Targets indications (14)

- **Condition identifier**  
EFO\_0003047
- **Condition identifier**  
EFO\_0004220
- **Condition identifier**  
EFO\_0009909

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0010721

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0001394

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005062

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005109

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005155

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005231

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005300

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005354

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0007256
- **Condition identifier**  
MONDO\_0008383
- **Condition identifier**  
MONDO\_0024327

**Highest recorded phase**  
2

### Reported adverse events (12)

- **Event**  
drug hypersensitivity

**Reports**  
7

**Reporting signal score**

86.4427
- **Event**  
dyspepsia

**Reports**  
143

**Reporting signal score**

128.937
- **Event**  
fatigue

**Reports**  
1,611

**Reporting signal score**  
1,792.25
- **Event**  
genotype drug resistance test positive

**Reports**  
64

**Reporting signal score**

202.725
- **Event**  
headache

**Reports**  
1,360

**Reporting signal score**  
1,523.8
- **Event**  
hepatic cirrhosis

**Reports**  
58

**Reporting signal score**

71.909
- **Event**  
hepatitis c

**Reports**  
275

**Reporting signal score**

716.497
- **Event**  
hepatitis c virus test positive

**Reports**  
29

**Reporting signal score**

98.7197
- **Event**  
hepatocellular carcinoma

**Reports**  
86

**Reporting signal score**

177.243
- **Event**  
insomnia

**Reports**  
326

**Reporting signal score**

231.03
- **Event**  
nausea

**Reports**  
769

**Reporting signal score**

298.226
- **Event**  
treatment failure

**Reports**  
257

**Reporting signal score**

297.649

### Trial references (15)

- NCT01740791  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01740791)
- NCT01817985  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01817985)
- NCT02468648  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02468648)
- NCT02745535  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02745535)
- NCT03057847  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03057847)
- NCT03888729  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03888729)
- NCT04382404  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04382404)
- NCT04695769  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04695769)
- NCT05895448  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05895448)
- NCT02002767  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02002767)
- NCT03222531  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03222531)
- NCT03801707  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03801707)
- NCT03809533  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03809533)
- NCT03818308  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03818308)
- NCT03819322  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03819322)

## Dosing

**Dose**

400 mg of sofosbuvir, 100 mg of velpatasvir, and 100 mg of voxilaprevir

**Route**

Oral

**How often**

Once daily

### Conditions of use

- Take with food

## Chemical properties

**Hydrogen bond acceptors**

10

**Hydrogen bond donors**

4

**Polar surface area**

193.1

**Calculated partition coefficient (ALogP)**

7.73

**Calculated partition coefficient (XLogP)**

6.2

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

11

**Heavy atoms**

65

**Molecular formula**

C49H54N8O8

**Monoisotopic mass**

882.40646071

**Natural product**

Yes

## National Drug Codes

- 61958-2201
- 61958-2203
- 61958-2204
- 61958-2205
- 61958-2401
- 72626-2701

## Evidence counts

**Recorded assays**

90

**Active assays**

35

### Active assay types

- Confirmatory

## Pharmacologic actions

- Antiviral Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000998.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

29

**Mean**

33.25

**Minimum**

25

**Maximum**

50

**Unit**

%

**Assays**

4

**Standard deviation**

11.3541

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (67)

- A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
- A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use
- A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
- A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
- A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
- A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
- AI-Powered Hepatitis C Single-Encounter Test-and-Treat
- Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet
- [C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV](https://trialight.com/data/trial/c-beyond-efficacy-and-safety-of-bem-rzr-vs-sof-vel-in-8852864b-1999-4a8c-bfdc-0866785761e6.md)
- [C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV](https://trialight.com/data/trial/c-forward-efficacy-and-safety-of-bem-rzr-vs-sof-vel-in-05ca8258-c0ba-4ce4-a169-221ec9d64e20.md)
- Combating Related Epidemics in HCV
- Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
- deLIVER: Direct Acting Antiviral Effects on the Liver
- Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis
- Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
- eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs
- Eliminating HCV Infection Among PWUD
- Elimination of Hepatitis C Virus Among Users of Substances
- Expanding the Pool in Lung Transplantation

### Approved for (1)

- [Chronic hepatitis C virus infection](https://trialight.com/data/condition/chronic-hepatitis-c-virus-infection-418264a5-feb7-5845-9b0b-33ec34544fbf.md)

### In development for (6)

- Chronic kidney disease Phase 2
- [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) Phase 2
- [Cirrhosis of liver](https://trialight.com/data/condition/cirrhosis-of-liver-d90e4a84-9e82-54fc-a553-1e42086e8382.md) Phase 3
- [Hepatitis C virus infection](https://trialight.com/data/condition/hepatitis-c-virus-infection-b3fd810d-71d3-57f9-8a11-71138c904f4d.md) Phase 2
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 3
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 2

### Other linked conditions (2)

- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md)
- [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md)

---

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