Velpatasvir

Summary

Velpatasvir (CHEMBL3545062) is an approved small-molecule antiviral drug; indicated across 2 conditions including chronic hepatitis c virus infection and hepatitis c virus infection.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• Indications: 2 conditions
• Clinical trials: 33
• Chemistry: 883 Da · C49H54N8O8

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3545062
Name	Velpatasvir
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	67683363
ChEBI	CHEBI:133009
Molecular formula	C49H54N8O8
Molecular weight	883
InChIKey	FHCUMDQMBHQXKK-CDIODLITSA-N

SMILES: C[C@H]1CC[C@H](N1C(=O)[C@H](C(C)C)NC(=O)OC)C2=NC3=C(N2)C=CC4=CC5=C(C=C43)OCC6=C5C=CC(=C6)C7=CN=C(N7)[C@@H]8C[C@@H](CN8C(=O)[C@@H](C9=CC=CC=C9)NC(=O)OC)COC

IUPAC name: methyl N-[(1R)-2-[(2S,4S)-2-[5-[6-[(2S,5S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.04,8.014,19]henicosa-1(13),2,4(8),5,9,11,14(19),15,17-nonaen-17-yl]-1H-imidazol-2-yl]-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

ChEBI definition: A complex organic heteropentacyclic compound that is a hepatitis C virus nonstructural protein 5A inhibitor used in combination with sofosbuvir (under the brand name Epclusa) for treatment of patients with chronic hepatitis C of all six major genotypes.

Pharmacological roles (ChEBI): antiviral drug, hepatitis C virus nonstructural protein 5A inhibitor.

Also known as: GS-5816, Velpatasvir, Velpatasvir component of epclusa, Velpatasvir component of vosevi, VELPATASVIR

Patent coverage: 373 distinct patent families (940 SureChEMBL compound mentions), from 6 matched compound structure(s). One matched structure accounts for 802 (85%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
chronic hepatitis C virus infection	4	MONDO:0005354	EFO:0004220

1 disease in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
hepatitis C virus infection	2	MONDO:0005231	EFO:0003047

Clinical trials

Total trials: 33.

Phase distribution

Phase	Trials
PHASE4	15
PHASE2	7
Not specified	7
PHASE1	4

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02064049	PHASE4	COMPLETED	Surveillance and Treatment of Prisoners With Hepatitis C
NCT02938013	PHASE4	COMPLETED	deLIVER: Direct Acting Antiviral Effects on the Liver
NCT03032666	PHASE4	COMPLETED	Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial
NCT03057847	PHASE4	COMPLETED	Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
NCT03086044	PHASE4	UNKNOWN	Transplanting Hepatitis C Positive Organs
NCT03235154	PHASE4	COMPLETED	A Pilot Study of Treating HCV at a Psychiatrist-staffed Outpatient Addiction Clinic
NCT03250910	PHASE4	COMPLETED	Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients
NCT03619837	PHASE4	COMPLETED	Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant
NCT03888729	PHASE4	UNKNOWN	Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)
NCT04653818	PHASE4	COMPLETED	HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial
NCT04695769	PHASE4	COMPLETED	Combined Ribavirin With Sofosbuvir/Velpatasvir/Voxilaprevir in Retreatment of Chronic Hepatitis C Non-responders
NCT04997564	PHASE4	UNKNOWN	The Efficacy and Safety of 12-week SOF/VEL Regimen Combined With Prophylactic Use of TAF for Treatment-naïve Genotype 1-6 HCV/HBV Co-infection Adult Patients With or Without Compensated Cirrhosis in China
NCT05467826	PHASE4	UNKNOWN	Efficacy and Safety of SOF/VEL + RBV and SOF/VEL/VOX for 12 Weeks in HCV Subjects With GT3b and Compensated Cirrhosis
NCT05717400	PHASE4	TERMINATED	Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy
NCT05895448	PHASE4	UNKNOWN	Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics
NCT03222531	PHASE2	ACTIVE_NOT_RECRUITING	Expanding the Pool in Orthotopic Heart Transplantation
NCT03809533	PHASE2	ACTIVE_NOT_RECRUITING	The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
NCT02468648	PHASE2	COMPLETED	Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
NCT02745535	PHASE2	COMPLETED	Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
NCT02836925	PHASE2	COMPLETED	Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection
NCT03818308	PHASE2	COMPLETED	Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
NCT03819322	PHASE2	COMPLETED	The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
NCT01740791	PHASE1	COMPLETED	Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
NCT01817985	PHASE1	COMPLETED	A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
NCT02002767	PHASE1	COMPLETED	Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
NCT03513393	PHASE1	COMPLETED	Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.
NCT06180590	Not specified	RECRUITING	The Efficacy of Vosevi in Treating DAA-experienced Patients
NCT06533319	Not specified	NOT_YET_RECRUITING	Hepatitis C Treatment in Idaho County Jails
NCT02333292	Not specified	COMPLETED	Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
NCT02510300	Not specified	TERMINATED	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
NCT02657694	Not specified	UNKNOWN	Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods
NCT03492112	Not specified	COMPLETED	A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
NCT04039698	Not specified	UNKNOWN	Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline, but PharmGKB curates 1 clinical and 1 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).