Product Description
Sofosbuvir is in a class of antiviral medications called nucleotide polymerase inhibitors. It works by decreasing the amount of hepatitis C virus (HCV) in the body. Sofosbuvir may not prevent the spread of hepatitis C to other people. (Sourced from: https://medlineplus.gov/druginfo/meds/a614014.html)
Mechanisms of Action: HCV-NS5B Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Hepatitis | Hepatitis, Chronic | Hepatocellular Carcinoma | Oncology Unspecified | Liver Transplant | Hepatitis C | Hepatitis C, Chronic | HIV Infections | Liver Cirrhosis | Liver Cirrhosis | Hepatitis | Hepatitis, Chronic | Hepatitis C | Hepatitis C, Chronic | Hepatitis | Hepatitis, Chronic | Hepatitis C | Hepatitis C, Chronic | Liver Cirrhosis | Hepatitis | Hepatitis, Chronic | Liver Transplant | Hepatitis C | Hepatitis C, Chronic | Liver Cirrhosis | Hepatitis | Hepatitis, Chronic | Hepatitis C | Hepatitis C, Chronic
Known Adverse Events: Headache | Insomnia | Anemia | Liver Cirrhosis | Diarrhea | Asthenia
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States, Unknown Location
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Arthritis|Hepatitis C, Chronic
Phase 2: Hepatitis A|Hepatitis C|Kidney Failure, Chronic|Porphyria Cutanea Tarda|Porphyria, Erythropoietic|Porphyrias, Hepatic|beta-Thalassemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| THINKER-NEXT | P2 |
Recruiting |
Kidney Failure, Chronic|Hepatitis C, Chronic |
2025-05-18 |
|
| STUDY19100377 | P1 |
Completed |
Hepatitis A|Hepatitis C, Chronic |
2023-10-16 |
|
| IRB00043341 | P2 |
Completed |
Porphyria Cutanea Tarda|Porphyrias, Hepatic|Porphyria, Erythropoietic|Hepatitis A|Hepatitis C |
2022-03-04 |
|
| HCV-art | P3 |
Active, not recruiting |
Arthritis |
2018-10-16 |