Drugs / Deleobuvir
Deleobuvir
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials · 1 missed | ||||||
| Phase 1 | NCT01941615 | Nov 2013 → Jan 2014 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT01983566 | Nov 2013 → Jan 2014 | — | Boehringer Ingelheim | Terminated | Missed primary |
| 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 | NCT01737996 | Nov 2012 → Mar 2013 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01605461 | May → Jun 2012 | — | 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 | NCT01347086 | May → Jun 2011 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182401 | Jul → Aug 2009 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT00905632 | May 2009 → Mar 2011 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182414 | May → Sep 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02176525 | Dec 2007 → Dec 2009 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02182388 | Jan → May 2007 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| 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 33 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| Phase 3 | NCT01858961 | May 2013 → Jul 2016 | chronic hepatitis C virus infection | Boehringer Ingelheim | Withdrawn | No outcome recorded |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 | Mixed |
| Phase 3 | NCT01728324 | Nov 2012 → Feb 2014 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | Mixed |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT01535638 Comparator | Feb → Mar 2012 | — | 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 · 9
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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. |
| 2012-10-01 | Boehringer Ingelheim | Results New Hepatitis C Data from Boehringer Ingelheim to be Presented at AASLD Annual Meeting prnewswire.com ↗
Addition of the NS5B polymerase inhibitor BI 207127 to pegylated interferon and ribavirin (PegIFN/RBV) for 4 weeks followed by PegIFN/RBV for 44 weeks improves SVR24 rates in treatment-naive patients with HCV genotype (GT) 1 and is well tolerated |
| 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 ↗ |
| 2011-11-07 | 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. |
| 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 9 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | deleobuvir | “HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection.” PMID 27920566 ↗ Nov 20163“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 with deleobuvir (BI 207127) and ribavirin” PMID 27920566 ↗ Nov 2016 “BI 207127 (Deleobuvir)” NCT01965431 ↗ |
| Known as | BI 207127 | “Faldaprevir (BI 201335) and deleobuvir (BI 207127) are direct-acting antiviral agents under development for the treatment of chronic HCV infection.” PMID 23558093 ↗ Apr 201316“faldaprevir with deleobuvir (BI 207127) and ribavirin” PMID 27920566 ↗ Nov 2016 |
| Known as | BI 207127 NA | “Single oral solution dose of BI 207127 NA combined with \[14C\]-BI 207127 NA” NCT01605461 ↗ |
| Known as | BI-207127 SODIUM SALT | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403318 ↗ |
| Known as | DELEOBUVIR SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL2403318 ↗ |
| Action | Inhibit | “BI 207127 is a potent non-nucleoside hepatitis C virus (HCV) NS5B polymerase inhibitor in vitro.” PMID 22414766 ↗ Mar 2012 |
| Modality | Small molecule | “BI 207127 is a potent non-nucleoside hepatitis C virus (HCV) NS5B polymerase inhibitor in vitro.” PMID 22414766 ↗ Mar 2012 |
| Route | Oral | “Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1” PMID 23558093 ↗ Apr 2013 |