Drugs / Odalasvir
Odalasvir
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT03277755 | Sep → Dec 2017 | — | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT03155893 | May → Oct 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03059303 | Feb → Apr 2017 | — | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02945020 | Nov 2016 → Jan 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02961660 | Nov 2016 → Apr 2018 | impaired renal function disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02889367 | Sep 2016 → Mar 2017 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02885454 | Aug → Dec 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02821858 | Jun → Sep 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02824315 | May → Oct 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01700179 | Sep 2012 → Sep 2013 | chronic hepatitis C virus infection | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02993250 | Dec 2016 → May 2018 | chronic hepatitis C virus infection | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT02765490 | Nov 2016 → Aug 2017 | chronic hepatitis C virus infection | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02569710 | Oct 2015 → May 2018 | chronic hepatitis C virus infection | Alios Biopharma Inc. | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT02512562 Comparator | Jul → Aug 2015 | chronic hepatitis C virus infection | Alios Biopharma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01849562 Comparator | Apr → Nov 2013 | chronic hepatitis C virus infection | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-10-23 | Medivir | Results Data on the clinical activity of simeprevir in combination with AL-335 and odalasvir (JNJ-4178) presented at the 2017 Liver Meeting™ medivir.com ↗
The triple combination was generally well-tolerated in both arms of the study, with the most frequent adverse events being headache and fatigue. |
| 2017-04-24 | Medivir | Results Update on the development of simeprevir as part of the triple combination with AL-335 and odalasvir (JNJ-4178) medivir.com ↗
The three-drug regimen achieved 100% SVR12 for 6- and 8-week treatment duration in treatment-naïve, GT1, non-cirrhotic patients. |
| 2016-09-23 | Medivir | Results Updated interim phase IIa data demonstrate that the combination of simeprevir, odalasvir and AL-335 has a high level of efficacy in HCV patients medivir.com ↗ |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | odalasvir | “A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone...” NCT03155893 ↗11“The purpose of this study is to evaluate the pharmacokinetics (PK) of AL-335, odalasvir (ODV) and its metabolites ALS-022399 and ALS-022227” NCT03277755 ↗ |
| Known as | ACH-0143102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01700179 ↗ |
| Known as | ACH-3102 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02512562 ↗ |
| Known as | ODV | “The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV)...” NCT03155893 ↗8“Part 1: Odalasvir (ODV) 25 mg taken orally as a component of FDC tablet in Treatment A, D and E and as a single agent tablet in Treatment C.” NCT03059303 ↗ “ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.” NCT02885454 ↗ “following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1)” NCT02821858 ↗ “Odalasvir (ODV)” NCT02824315 ↗ “Odalasvir (ODV)” NCT02993250 ↗ “Odalasvir (ODV)” NCT02569710 ↗ “odalasvir (ODV)” NCT02765490 ↗ |
| Action | Inhibit | “Nonstructural protein 5A inhibitor.” NCT01849562 ↗ |
| Modality | Small molecule | — CHEMBL3544977 ↗ |
| Route | Oral | “oral ACH-0143102 administered” NCT01700179 ↗ |