Drugs / Faldaprevir
Faldaprevir
also known as
BI 201335 · BI 201335 NA · FDV · BI-201335 NA SALT · BI-201335 SODIUM SALT · FALDAPREVIR SODIUM · Faldaprevir, sodium salt
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | chronic hepatitis C virus infection | 2014-03-06 | “The New Drug Application (NDA) for faldaprevir has been accepted for filing by the U.S. Food and Drug Administration (FDA).” prnewswire.com ↗ |
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | — | “the faldaprevir application for marketing authorization is under review by the European Medicines Agency (EMA).” prnewswire.com ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 125 trials · 1 missed | ||||||
| Phase 1 | NCT02114671 | Apr → Oct 2014 | — | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 1 | NCT02016625 | Dec 2013 → Apr 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01941615 | Nov 2013 → Jan 2014 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01957657 | Oct → Dec 2013 | impaired renal function disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01965431 | Oct 2013 → Jan 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01821937 | Mar → May 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01785160 | Feb → Mar 2013 | — | Boehringer Ingelheim | Completed | Missed primary |
| Phase 1 | NCT01795937 | Feb → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01764945 | Jan → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01737996 | Nov 2012 → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01525628 | Apr 2012 → Dec 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01580306 | Apr → Jun 2012 | hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01374802 | Jun → Jul 2011 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01340196 | Apr → Jun 2011 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182375 | Jan → Mar 2010 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182401 | Jul → Aug 2009 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT02182349 | Jun → Jul 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01909778 | Jun → Oct 2008 | cirrhosis of liver, hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182336 | Jun → Sep 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182310 | Jun → Oct 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182297 | Apr → Dec 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182284 | Jan → Feb 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00793793 | Sep 2007 → Jan 2011 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182362 | May 2007 → Feb 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182323 | Sep → Dec 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 28 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT02716428 | May 2016 → Sep 2017 | chronic hepatitis C virus infection | Trek Therapeutics, PBC | Completed | No outcome recorded |
| Phase 2 | NCT02593162 | Oct 2015 → Dec 2016 | chronic hepatitis C virus infection | Trek Therapeutics, PBC | Completed | No outcome recorded |
| Phase 2 | NCT01830127 | Apr 2013 → Oct 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01528735 | Feb 2012 → Aug 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01132313 | May 2010 → Oct 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Phase 2 | NCT00984620 | Sep 2009 → Apr 2011 | hepatitis C virus infection | Boehringer Ingelheim | Completed | Missed primary |
| Phase 2 | NCT00947349 | Jul 2009 → Aug 2011 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00774397 | Oct 2008 → Nov 2011 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Phase 310 trials · 4 met primary | ||||||
| Phase 3 | NCT01858961 | May 2013 → Jul 2016 | chronic hepatitis C virus infection | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 3 | NCT01732796 | Dec 2012 → Jan 2015 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Mixed |
| Phase 3 | NCT01728324 | Nov 2012 → Feb 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Mixed |
| Phase 3 | NCT01608737 | Sep 2012 → Oct 2015 | chronic hepatitis C virus infection | Boehringer Ingelheim | Withdrawn | No outcome recorded |
| Phase 3 | NCT01579474 | Apr 2012 → Dec 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01399619 | Sep 2011 → Sep 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01330316 | Jul 2011 → Jun 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01358864 | Jun 2011 → Feb 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01343888 | Apr 2011 → Mar 2014 | hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT01297270 | Apr 2011 → Apr 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT01694706 Comparator | Sep → Dec 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01637922 Comparator | Aug → Nov 2012 | hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01570244 Comparator | Apr → Aug 2012 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01859962 Comparator | May 2013 → May 2014 | chronic hepatitis C virus infection | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2014-03-06 | Boehringer Ingelheim | Results Boehringer Ingelheim Announces Phase 3 SVR12 Results in HCV/HIV Co-Infected Patients Treated with Faldaprevir prnewswire.com ↗
Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. |
| 2013-11-02 | Boehringer Ingelheim | Results Phase 3 data show viral cure rates achieved in a broad range of patients with genotype-1 hepatitis C taking investigational compound faldaprevir plus PegIFN/RBV prnewswire.com ↗
Also in the pooled analysis, 84% (436/521) of patients who received a regimen including 120mg of faldaprevir once-daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. |
| 2013-11-02 | Boehringer Ingelheim | Results Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising interim Phase 2a data prnewswire.com ↗
all patients (13/13) who reached the 4-week post-treatment follow-up had undetectable levels of hepatitis C virus (SVR4) with an investigational, 12-week, all-oral regimen of faldaprevir and deleobuvir |
| 2013-10-08 | Boehringer Ingelheim | Results Investigational interferon-free regimen demonstrates undetectable hepatitis C virus in all patients reaching end of treatment in ongoing Phase 2 trial prnewswire.com ↗
Additionally, 100 percent of patients who have completed treatment (13/13) achieved non-detectable levels of virus at the end of treatment. |
| 2013-04-23 | Boehringer Ingelheim | Results Boehringer Ingelheim's Faldaprevir-Based Treatment Regimen Achieved Viral Cure in up to 80 Percent of Patients with Hepatitis C in Phase 3 Pivotal Trial prnewswire.com ↗
In previously untreated patients with genotype-1 hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed (SVR12). |
| 2013-04-23 | Boehringer Ingelheim | Results Boehringer Ingelheim's Faldaprevir-Based Treatment Regimen Achieved Viral Cure in up to 80 per cent of Patients with Hepatitis C in Phase 3 Pivotal Trial(1) prnewswire.com ↗
In previously untreated patients with genotype-1 hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed (SVR12). |
| 2012-11-10 | Boehringer Ingelheim | Results Phase 2b Data of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Show Viral Cure Achieved in Up to 85% of Treatment-Naive Patients prnewswire.com ↗
A viral cure was achieved for 69 percent of all patients included in the study (both GT1a and GT1b HCV infections), and includes patients with advanced liver disease that are more challenging to cure. |
| 2012-04-19 | Boehringer Ingelheim | Results Phase 2b Study of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Shows Undetectable Virus in HCV Genotype-1 Patients 12 Weeks After Treatment Ended (SVR12) prnewswire.com ↗
Furthermore, a separate arm of the SOUND-C2 study showed that after 16 weeks of interferon-free treatment, SVR12 was achieved in 59 percent of patients. |
| 2012-04-19 | Boehringer Ingelheim | Results Phase 2b Data Show SVR12 in Cirrhotic HCV Patients Treated with Interferon-Free Regimen prnewswire.com ↗ |
| 2011-11-08 | Boehringer Ingelheim | Results Sustained Viral Response from Phase 2 Studies of BI 201335, Including Difficult-to-Treat HCV Patient Types prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from two Phase 2 studies evaluating the combination of the company's protease inhibitor, BI 201335, with pegylated interferon (PegIFN) and ribavirin (RBV) in treatment-naive genotype-1 (GT1) hepatitis C virus (HCV) patients. |
| 2011-11-07 | Boehringer Ingelheim | Results Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD prnewswire.com ↗
They show that BI 201335 plus BI 207127 with ribavirin suppressed the hepatitis C virus to undetectable levels in the majority of patients in this study. |
| 2011-04-02 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim's Lead Hepatitis C Compound Moves into Phase 3 - the First Within the BI HCV Portfolio prnewswire.com ↗
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development programs for BI 201335 in combination with pegylated interferon and ribavirin and as part of an interferon-free combination with the polymerase inhibitor, BI 207127, in chronic genotype-1 HCV patients. |
| 2011-04-01 | Boehringer Ingelheim | Results Positive Phase 2 Results Reported with Boehringer Ingelheim's Investigational HCV Protease Inhibitor in Both Previously Treated and Untreated Patients prnewswire.com ↗
Results from SILEN-C1 show a sustained viral response (SVR) in 71 to 83 percent of treatment-naive patients who received BI 201335 once-daily plus the current standard-of-care (SOC) [pegylated interferon (PegIFN) and ribavirin (RBV)]. |
| 2010-10-30 | Boehringer Ingelheim | Results Results of Boehringer Ingelheim Oral Hepatitis C Protease Inhibitor and Polymerase Inhibitor Combination Phase Ib Trial Shows Rapid Viral Response Without Use of Pegylated Interferon prnewswire.com ↗
In the lower and higher dose groups, 73 and 100% of patients achieved a rapid virological response (i.e. HCV RNA below lower limit of quantification after 4 weeks of treatment). |
All press releases naming this drug 14 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 48 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Faldaprevir | “Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)” NCT01343888 ↗21“Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)” NCT01297270 ↗ “Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)” NCT01399619 ↗ “Faldaprevir (BI 201335) and deleobuvir (BI 207127) are direct-acting antiviral agents under development for the treatment of chronic HCV infection.” PMID 23558093 ↗ Apr 2013 “Faldaprevir (BI 201335) is a selective NS3/4A protease inhibitor under development for the treatment of chronic hepatitis C virus (HCV) infection.” PMID 23877706 ↗ Jul 2013 “BI 201335 (Faldaprevir)” NCT01358864 ↗ |
| Known as | BI 201335 | “Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)” NCT01297270 ↗29“Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)” NCT01399619 ↗ “Faldaprevir (BI 201335) and deleobuvir (BI 207127) are direct-acting antiviral agents under development for the treatment of chronic HCV infection.” PMID 23558093 ↗ Apr 2013 “Faldaprevir (BI 201335) is a selective NS3/4A protease inhibitor under development for the treatment of chronic hepatitis C virus (HCV) infection.” PMID 23877706 ↗ Jul 2013 “Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers” NCT01821937 ↗ “BI 201335 (Faldaprevir)” NCT01732796 ↗ |
| Known as | BI 201335 NA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01528735 ↗ |
| Known as | BI-201335 NA SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL1241348 ↗ |
| Known as | BI-201335 SODIUM SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL1241348 ↗ |
| Known as | FALDAPREVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1241348 ↗ |
| Known as | Faldaprevir, sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1241348 ↗ |
| Known as | FDV | “Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in...” NCT01941615 ↗1“The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus” NCT02016625 ↗ |
| Action | Inhibit | “Faldaprevir (BI 201335) is a selective NS3/4A protease inhibitor” PMID 23877706 ↗ Jul 2013 |
| Modality | Small molecule | — CHEMBL1241348 ↗ |
| Route | Oral | “Multiple Rising Oral Doses of BI 201335” NCT00947349 ↗ |