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
Trials 43 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 125 trials | ||||||
| Phase 1 | NCT02114671 | Apr → Oct 2014 | — | Boehringer Ingelheim | Withdrawn | No outcome recorded |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 | NCT01965431 | Oct 2013 → Jan 2014 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01957657 | Oct → Dec 2013 | impaired renal function disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01821937 | Mar → May 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01795937 | Feb → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01785160 | 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 | NCT01580306 | Apr → Jun 2012 | hepatitis C virus infection | 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 | 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 | NCT02182310 | Jun → Oct 2008 | — | 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 | 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT00984620 | Sep 2009 → Apr 2011 | hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 310 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT01728324 | Nov 2012 → Feb 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT01297270 | Apr 2011 → Apr 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01343888 | Apr 2011 → Mar 2014 | hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 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 21 trial | ||||||
| Phase 2 | NCT01859962 Comparator | May 2013 → May 2014 | chronic hepatitis C virus infection | Presidio Pharmaceuticals, Inc. | Completed | No outcome recorded |
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 NCT02182401 ↗ |
| 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 ↗ |