Ledipasvir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Harvoni | — | 2014-11-17 | europa.eu ↗ |
| Approved | US (FDA) | HARVONI | — | 2014-10-10 | fda.gov ↗ |
Trials 50 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03188276 Comparator | Feb 2016 → May 2017 | chronic hepatitis C virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT03005210 Comparator | Nov 2016 | — | Genuine Research Center, Egypt | Completed | No outcome recorded |
| Phase 1 | NCT01193478 Comparator | Aug 2010 → Jan 2011 | hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01435226 Comparator | Sep 2011 → Jan 2013 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01434498 Comparator | Sep 2011 → Jan 2013 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01356160 Comparator | Jul 2011 → Jun 2013 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01353248 Comparator | May 2011 → Oct 2012 | chronic hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03343444 Comparator | Apr 2017 → Nov 2018 | chronic hepatitis C virus infection | Egyptian Liver Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02363517 Comparator | Feb 2015 → Dec 2018 | hepatitis C virus infection, substance abuse | Macfarlane Burnet Institute for Medical Research and Public Health Ltd | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02347345 Comparator | Nov 2016 | hepatitis C virus infection | Rockefeller University | Completed | No outcome recorded |
| Phase 4 | NCT02992457 Comparator | Jan 2015 → Dec 2018 | hepatitis C virus infection | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT03133065 Comparator | Sep 2014 → Dec 2016 | — | Ain Shams University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03481036 Comparator | Jun 2016 → Dec 2020 | chronic hepatitis C virus infection | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
Press releases naming this drug 15 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-12-04 | Gilead Sciences | China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com ↗ |
| 2018-09-24 | Gilead Sciences | Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C gilead.com ↗ |
| 2017-04-21 | Gilead Sciences | Gilead Announces Scientific Presentations Demonstrating Efficacy of Harvoni® (Ledipasvir/Sofosbuvir) in Special Patient Populations With HCV Infection gilead.com ↗ |
| 2014-11-18 | Gilead Sciences | European Commission Grants Marketing Authorization for Gilead’s Harvoni®▼ (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4 gilead.com ↗ |
| 2014-10-16 | Gilead Sciences | Health Canada Issues Notice of Compliance for Gilead’s Harvoni™ (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗ |
| 2014-10-10 | Gilead Sciences | U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗ |
| 2014-09-26 | Gilead Sciences | European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults gilead.com ↗ |
| 2014-09-24 | Gilead Sciences | Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗ |
| 2014-06-15 | Gilead Sciences | Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained Virologic Response (SVR12) Among Patients with Chronic Hepatitis C in Japan gilead.com ↗ |
| 2014-04-07 | Gilead Sciences | Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗ |
| 2014-03-27 | Gilead Sciences | European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Chronic Hepatitis C Infection gilead.com ↗ |
| 2014-02-10 | Gilead Sciences | Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗ |
| 2013-12-18 | Gilead Sciences | Gilead Announces SVR12 Rates From Three Phase 3 Studies Evaluating a Once-Daily Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients gilead.com ↗ |
| 2013-03-26 | Gilead Sciences | Gilead Announces Update on Phase 3 Study of Oral Fixed-Dose Combination of Sofosbuvir and Ledipasvir for Genotype 1 Hepatitis C Patients gilead.com ↗ |
| 2012-11-10 | Gilead Sciences | Gilead Announces 100 Percent Sustained Virologic Response Rate (SVR4) for an Interferon-Free Regimen of Sofosbuvir (GS-7977), GS-5885 and Ribavirin in Treatment-Naïve Genotype 1 Hepatitis C Infected Patients gilead.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ledipasvir | “This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide...” NCT02707601 ↗54“This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549 ↗ “Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 2016 “After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the...” NCT03126370 ↗ “Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease” NCT02691728 ↗ “Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.” PMID 27198664 ↗ May 2016 “For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection” NCT03764345 ↗ “One hundred patients aged 12-17 years received a combination tablet of 90 mg ledipasvir and 400 mg sofosbuvir once daily for 12 weeks.” PMID 27997679 ↗ Jun 2017 “Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)” NCT02405013 ↗ “Patients were given ledipasvir (90 mg) plus sofosbuvir (400 mg) as a fixed-dose combination tablet once daily for 6 weeks.” PMID 28029529 ↗ Oct 2016 “Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks.” NCT02480166 ↗ “One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks” NCT03118674 ↗ “the hepatitis C virus NS5A inhibitor ledipasvir and the NS5B nucleotide polymerase inhibitor sofosbuvir” PMID 25863559 ↗ Apr 2015 “Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg).” NCT03743727 ↗ “Fixed dose combination of sofosbuvir 400 mg plus ledipasvir 90 mg once daily plus ribavirin 1000 mg” NCT03483987 ↗ “sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV)” NCT03488485 ↗ “Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir” NCT04039958 ↗ “2 recipient are treated with sofosbuvir 400mg + ledipasvir 90mg for 24 weeks” NCT03133065 ↗ “Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR\>30” NCT03702218 ↗ “Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1” NCT02705534 ↗ “Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1.” PMID 26196665 ↗ Jul 2015 “1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir” NCT03005210 ↗ “Ledipasvir (LDV) tablets administered orally once daily” NCT01260350 ↗ “Sofosbuvir and Ledipasvir with weight based Ribavirin” NCT03481036 ↗ “combination of sofosbuvir plus ledipasvir (SOF + LDP)” NCT02363517 ↗ “Sofosbuvir + Ledipasvir” NCT02469012 ↗ |
| Known as | GS-5885 | “a fixed dose combination of GS-7977 and GS-5885 in HIV/HCV Genotype 1 (GT-1) subjects” NCT01878799 ↗8“Ledipasvir is also known as GS-5885.” NCT02125500 ↗ |
| Known as | LDP | “combination of sofosbuvir plus ledipasvir (SOF + LDP)” NCT02363517 ↗ |
| Known as | LDV | “This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) +...” NCT02226549 ↗10“containing the NS5B polymerase inhibitor sofosbuvir (SOF) 90 mg and the NS5A inhibitor ledipasvir (LDV) 400mg, marked a new era of IFN and ribavirin free, directly acting...” NCT02683005 ↗ “In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]).” NCT03483987 ↗ “Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily” NCT02309918 ↗ “combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4” NCT03743727 ↗ “G1, 4, 5, and 6 patients were treated with SOF+ledipasvir (LDV)+RBV for 12 weeks” PMID 30211847 ↗ Jan 2019 “sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV)” NCT03488485 ↗ “Includes 400 mg sofosbuvir (SOF) and 90 mg ledipasvir (LDV)” NCT02858180 ↗ “Ledipasvir (LDV) tablets administered orally once daily” NCT01260350 ↗ “sofosbuvir (SOF)/ledipasvir (LDV)” NCT01975675 ↗ “Ledipasvir (LDV)” NCT02421211 ↗ |
| Known as | Ledipasvir (GS-5885) | “Ledipasvir (GS-5885)” NCT01805882 ↗ |
| Known as | Ledipasvir acetonate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2374220 ↗ |
| Known as | Ledipasvir component of harvoni | ChEMBL registry synonym — accepted as the source's own label CHEMBL2374220 ↗ |
| Action | Inhibit | “GS-5885 is a novel hepatitis C virus (HCV) NS5A inhibitor.” PMID 23877691 ↗ Jul 2013 |
| Modality | Small molecule | “NS5A inhibitor ledipasvir” PMID 24262278 ↗ Nov 2013 |
| Route | Oral | “tablet, oral, 3 mg once daily for 3 days” NCT01193478 ↗ |