Velpatasvir
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2016
- First approval year
- 2016
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Velpatasvir
- Molecular weight
- 883.02
- 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
- velpatasvir component of epclusa
- Velpatasvir component of epclusa
- velpatasvir component of vosevi
- Velpatasvir component of vosevi
- 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.
- CAS registry numbers
- 1377049-84-7
- ChEMBL ID
- CHEMBL3545062
- InChIKey
- FHCUMDQMBHQXKK-CDIODLITSA-N
- PubChem compound IDs
- 67683363
- RxNorm IDs (RxCUI)
- 1799206
- FDA ingredient codes (UNII)
- KCU0C7RS7Z
- Applicant
- GILEAD SCIENCES INC
- Approval date
- 28 Jun 2016
- Application number
- NDA208341
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- 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
- 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)
- 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
- 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
- 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
- NCT01740791
- NCT01817985
- NCT02468648
- NCT02745535
- NCT03057847
- NCT03888729
- NCT04382404
- NCT04695769
- NCT05895448
- NCT02002767
- NCT03222531
- NCT03801707
- NCT03809533
- NCT03818308
- NCT03819322
- 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
- 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
- 61958-2201
- 61958-2203
- 61958-2204
- 61958-2205
- 61958-2401
- 72626-2701
- Recorded assays
- 90
- Active assays
- 35
Active assay types
- Confirmatory
- Antiviral Agents
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
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
- 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)
In development for (6)
- Chronic kidney disease Phase 2
- Chronic renal failure syndrome Phase 2
- Cirrhosis of liver Phase 3
- Hepatitis C virus infection Phase 2
- HIV infectious disease Phase 3
- Lymphoma Phase 2