Sofosbuvir
drugOn this page
Also known as GS-7977GS7977PSI-7977Sofosbuvir component of epclusaSofosbuvir component of harvoniSofosbuvir component of voseviSovaldi
Summary
Sofosbuvir (CHEMBL1259059) is an approved small-molecule prodrug (ATC J05AP08); indicated across 8 conditions including hepatitis c virus infection and chronic hepatitis c virus infection.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: J05AP08
- Indications: 8 conditions
- Clinical trials: 184
- Chemistry: 529.5 Da · C22H29FN3O9P
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1259059 |
| Name | Sofosbuvir |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 45375808 |
| ChEBI | CHEBI:85083 |
| ATC | J05AP08 |
| Molecular formula | C22H29FN3O9P |
| Molecular weight | 529.5 |
| InChIKey | TTZHDVOVKQGIBA-IQWMDFIBSA-N |
SMILES: C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3
IUPAC name: propan-2-yl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate
ChEBI definition: A nucleotide conjugate that is used in combination with ledipasvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection.
Pharmacological roles (ChEBI): prodrug, antiviral drug, hepatitis C protease inhibitor.
Also known as: GS-7977, GS7977, PSI-7977, Psi-7977, gs-7977, Sofosbuvir, Sofosbuvir component of epclusa, Sofosbuvir component of harvoni, Sofosbuvir component of vosevi, Sovaldi, SOFOSBUVIR, sofosbuvir
Patent coverage: 1,376 distinct patent families (3,111 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Cytochrome P450 2C9, Cytochrome P450 3A4.
Bioactivity
ChEMBL activities: 1 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):
| Target | pChembl | Type | Value | Unit | Activity ID |
|---|---|---|---|---|---|
| CYP3A4 | 5.08 | IC50 | 8400 | nM | CHEMBL_ACT_18080259 |
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
8 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| hepatitis C virus infection | 4 | MONDO:0005231 | EFO:0003047 |
| chronic hepatitis C virus infection | 4 | MONDO:0005354 | EFO:0004220 |
| viral infectious disease | 4 | MONDO:0005108 | EFO:0000763 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | EFO:0000694 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| hepatitis B virus infection | 2 | MONDO:0005344 | EFO:0004197 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 184.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 47 |
| PHASE4 | 46 |
| PHASE3 | 34 |
| Not specified | 33 |
| PHASE2/PHASE3 | 13 |
| PHASE1 | 7 |
| PHASE1/PHASE2 | 2 |
| EARLY_PHASE1 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06953479 | PHASE4 | RECRUITING | Implementing Low-Barrier HCV Treatment in a Jail Setting |
| NCT07560046 | PHASE4 | NOT_YET_RECRUITING | Combating Related Epidemics in HCV |
| NCT02064049 | PHASE4 | COMPLETED | Surveillance and Treatment of Prisoners With Hepatitis C |
| NCT02128542 | PHASE4 | COMPLETED | Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis |
| NCT02156570 | PHASE4 | COMPLETED | DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral) |
| NCT02168361 | PHASE4 | COMPLETED | The SIM-SOF Trial for Hepatitis C |
| NCT02206932 | PHASE4 | WITHDRAWN | A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C |
| NCT02214420 | PHASE4 | COMPLETED | SMV + SOF With/Without RBV for IFN-II Patients With CHC |
| NCT02304159 | PHASE4 | COMPLETED | Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics |
| NCT02485080 | PHASE4 | WITHDRAWN | Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1 |
| NCT02624063 | PHASE4 | COMPLETED | Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT) |
| NCT02631772 | PHASE4 | COMPLETED | LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients |
| NCT02702739 | PHASE4 | COMPLETED | Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients |
| NCT02717949 | PHASE4 | TERMINATED | Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study |
| NCT02768961 | PHASE4 | COMPLETED | Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C) |
| NCT02781649 | PHASE4 | COMPLETED | Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients |
| NCT02804386 | PHASE4 | COMPLETED | Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon |
| NCT02858180 | PHASE4 | COMPLETED | Hepatitis C Virus(HCV) Heart and Lung Study |
| NCT02938013 | PHASE4 | COMPLETED | deLIVER: Direct Acting Antiviral Effects on the Liver |
| NCT02964091 | PHASE4 | COMPLETED | Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World |
| NCT02992457 | PHASE4 | COMPLETED | Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection |
| 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 |
| NCT03105349 | PHASE4 | WITHDRAWN | A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A |
| NCT03200184 | PHASE4 | COMPLETED | Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients |
| 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 |
| NCT03313414 | PHASE4 | WITHDRAWN | HCV Post-Exposure Prophylaxis for Health Care Workers |
| NCT03389061 | PHASE4 | WITHDRAWN | Bioequivalence Study of Crushed Sofosbuvir/Velpatasvir Compared to the Whole Tablet |
| NCT03402165 | PHASE4 | UNKNOWN | Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C |
| NCT03512210 | PHASE4 | COMPLETED | Monitoring SOF/VEL in Treatment Naïve, HCV Participants With Active Infection |
| NCT03537196 | PHASE4 | COMPLETED | DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) |
| NCT03619837 | PHASE4 | COMPLETED | Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant |
| NCT03721627 | PHASE4 | UNKNOWN | Chronic Hepatitis C Treatment in Egyptian Children With Gaucher Disease. |
| NCT03949764 | PHASE4 | COMPLETED | The Kentucky Viral Hepatitis Treatment Study |
| NCT04169464 | PHASE4 | UNKNOWN | The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy |
| NCT04457050 | PHASE4 | COMPLETED | Effect of Hepatitis C Clearance on Insulin Resistance |
| NCT04498936 | PHASE4 | COMPLETED | Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19 |
| NCT04653818 | PHASE4 | COMPLETED | HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline, but PharmGKB curates 6 clinical and 21 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).