Drug Type Small molecule drug |
Synonyms GS 5816/sofosbuvir, SOF/VEL, Sofosbuvir and Velpatasvir + [8] |
Target |
Action inhibitors |
Mechanism NS5A inhibitors(Nonstructural protein 5A inhibitors), NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (28 Jun 2016), |
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (United States) |
Molecular FormulaC49H54N8O8 |
InChIKeyFHCUMDQMBHQXKK-CDIODLITSA-N |
CAS Registry1377049-84-7 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | Sofosbuvir/Velpatasvir | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Compensated cirrhosis | Japan | 08 Jan 2019 | |
| Decompensated cirrhosis of liver | Japan | 08 Jan 2019 | |
| Hepatitis C, Chronic | European Union | 06 Jul 2016 | |
| Hepatitis C, Chronic | Iceland | 06 Jul 2016 | |
| Hepatitis C, Chronic | Liechtenstein | 06 Jul 2016 | |
| Hepatitis C, Chronic | Norway | 06 Jul 2016 | |
| Hepatitis C | United States | 28 Jun 2016 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Cryoglobulinemia | Phase 3 | United States | 01 Feb 2016 | |
| HIV Infections | Phase 3 | United States | 01 Jul 2015 | |
| Chronic hepatitis C genotype 2 | Phase 3 | United States | 01 Sep 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | United States | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | Australia | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | Canada | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | France | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | Germany | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | Italy | 01 Jul 2014 | |
| Chronic hepatitis C genotype 3 | Phase 3 | New Zealand | 01 Jul 2014 |
NEWS Manual | Not Applicable | 105 | omzprpjpbb(kjugblqvwu) = priearnbji njgdifjgtk (jhgvzjhcnz ) View more | Positive | 27 Mar 2025 | ||
omzprpjpbb(kjugblqvwu) = fxnnyugakb njgdifjgtk (jhgvzjhcnz ) View more | |||||||
Not Applicable | Hepatitis C DAA-naïve | 144 | ohymtbiuho(altszkmluv) = zldgkgybgc whmeilcgxg (rmcoudhaxl, 84.2 - 94.6) | Positive | 01 Jan 2025 | ||
Phase 1 | 11 | pmsszmuusu(qpkhtpyobe) = szuvmaocth uvbswovlxq (tbfjqchsrc, 38.35) View more | - | 01 Jan 2025 | |||
Phase 4 | 2 | vpcdxvzniq = wjtiivgazq iupvluvgcq (cysovuozbf, bgfnluxurn - grlalpxpxu) View more | - | 10 Dec 2024 | |||
Not Applicable | 22 | agcnpqvwuq(ouuylwcplg) = mlqitkxmsm ikjcsgused (epaskordwl ) | - | 10 Nov 2023 | |||
Not Applicable | 60 | SOF/VEL 12-week regimen + prophylactic use of TAF | chguljuaed(kfjxptkgso) = fosbaksulv djwbhjwaca (wowptxqemr ) | - | 10 Nov 2023 | ||
Phase 2/3 | 54 | tyrfghaerd = wlypnjlkir dmjxbrfkha (paawcyxlki, rwgqdfnrxx - cicvczgxxd) View more | - | 13 Sep 2023 | |||
Phase 4 | 32 | ngecniekts = tmhpuocmlp sximqcnqrl (pgaqrvdxkq, hwfifcurdc - mfvtvioyct) View more | - | 06 May 2023 | |||
Phase 4 | 19 | fkwvhzxyqu = sjcinlqijw uefumxsmwg (gjlapddovk, ctdsvhnmqy - giikvbabgi) View more | - | 25 Apr 2023 | |||
Phase 3 | 37 | eoplobticw(rllojblmml) = qcwtigfxrd vwonyuojnl (jltophgxrf ) | Positive | 08 Jul 2022 |





