Ledipasvir
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hepatitis C virus infection 1 milestone | |||||
| Filed | Japan (PMDA) | — | hepatitis C virus infection | 2014-09-24 | “Submitted a New Drug Application (NDA) to Japan's Pharmaceutical and Medical Devices Agency for approval of a once-daily fixed-dose combination of ledipasvir” gilead.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Harvoni | — | 2014-11-17 | europa.eu ↗ |
| Approved | US (FDA) | HARVONI | — | 2014-10-10 | fda.gov ↗ |
Trials 50
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data on Viral Hepatitis at the International Liver Congress™ 2019 gilead.com ↗ |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis (poster #0138) |
| 2018-12-04 | Gilead Sciences | Regulatory China’s National Medical Products Administration Approves Harvoni® (Ledipasvir/Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Genotype 1-6 gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the National Medical Products Administration (NMPA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years. |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Latest Data from Viral Hepatitis Research Programs at The Liver Meeting® 2018 gilead.com ↗
These results, along with data from Gilead’s hepatitis B virus (HBV) cure development program, are being presented at The Liver Meeting ® 2018 in San Francisco this week. |
| 2017-04-07 | Gilead Sciences | Regulatory U.S. FDA Approves New Indications for Harvoni® and Sovaldi® in Pediatric Patients 12 Years and Older with Chronic Hepatitis C Infection gilead.com ↗
Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. |
| 2016-04-16 | Gilead Sciences | Results Gilead Announces Multiple Scientific Presentations Demonstrating Broad Utility of Sofosbuvir-Based Hepatitis C Therapies gilead.com ↗
new data highlighting the potential use of Harvoni ® (ledipasvir/sofosbuvir) in adolescents aged 12 to 17. |
| 2016-02-16 | Gilead Sciences | Regulatory U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease gilead.com ↗
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration ( FDA ) has approved additional indications for Harvoni ® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. |
| 2015-07-03 | Gilead Sciences | Regulatory Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Harvoni®, the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. |
| 2015-04-25 | Gilead Sciences | Results Gilead Announces Results From Studies Evaluating Sofosbuvir-Based Regimens in Chronic Hepatitis C Patients With Genotypes 2-5 gilead.com ↗
Separately, results from a Phase 2 study demonstrate the safety and efficacy of Harvoni ® (ledipasvir 90 mg/sofosbuvir 400 mg) in patients with genotypes 4 or 5 infection. |
| 2015-04-23 | Gilead Sciences | Results Gilead’s Harvoni and Sovaldi Demonstrate Efficacy and Safety among Chronic Hepatitis C Patients with Advanced Liver Disease gilead.com ↗ |
| 2015-02-26 | Gilead Sciences | Results Gilead Announces SVR12 Rates From Phase 3 Study Evaluating Harvoni® for the Treatment of Chronic Hepatitis C in Patients Co-Infected With HIV gilead.com ↗
In the trial, 96 percent (n=321/335) of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). |
| 2014-11-11 | Gilead Sciences | Results Gilead Announces Harvoni Study Results in Chronic Hepatitis C Patients with Advanced Liver Disease and Those Who Failed Prior Treatment gilead.com ↗
Ninety-six percent (n=74/77) of those receiving Harvoni plus RBV for 12 weeks and 97 percent (n=75/77) of those receiving Harvoni for 24 weeks achieved SVR12. |
| 2014-10-16 | Gilead Sciences | Regulatory 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 ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has issued a Notice of Compliance for Harvoni™ (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. |
| 2014-10-10 | Gilead Sciences | Regulatory 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 | Regulatory European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults gilead.com ↗
The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest. |
| 2014-04-07 | Gilead Sciences | Regulatory Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection gilead.com ↗
The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. |
| 2014-02-10 | Gilead Sciences | Regulatory Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C gilead.com ↗ |
| 2013-01-07 | Gilead Sciences | Results Gilead Provides Update on Hepatitis C Development Programs gilead.com ↗
Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients |
| 2012-11-10 | Gilead Sciences | Results 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 ↗
Among treatment-naïve patients receiving this combination, 100 percent (n=25/25) remained HCV RNA undetectable four weeks after completing therapy (SVR4). |
All press releases naming this drug 27 releases
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 ↗ |
| 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 ↗ |