Drugs / ADAFOSBUVIR
ADAFOSBUVIR
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 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| Phase 1 | NCT03277755 | Sep → Dec 2017 | — | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |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 | NCT02894905 | Sep 2016 → Aug 2017 | impaired renal function disease | 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 | NCT02339207 | Dec 2014 → May 2016 | chronic hepatitis C virus infection | Alios Biopharma 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 therapy1 trial | ||||||
| Phase 1 | NCT02512562 Comparator | Jul → Aug 2015 | chronic hepatitis C virus infection | Alios Biopharma Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| 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 ↗ |
| 2016-09-09 | Medivir | Results Interim results from phase IIa trial evaluating triple combination including simeprevir demonstrates high level of efficacy in HCV patients medivir.com ↗
Interim results from cohorts 1-4, summarized in the table below, showed that the triple combination regimen, including simeprevir, was highly effective and well tolerated in non-cirrhotic patients with GT1 HCV. |
All press releases naming this drug 8 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADAFOSBUVIR | ChEMBL registry synonym — accepted as the source's own label CHEMBL4129286 ↗ |
| Known as | AL-335 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02824315 ↗ |
| Known as | JNJ-335 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4129286 ↗ |
| Action | Inhibit | “The nucleotide analog AL-335 is a pangenotypic hepatitis C virus (HCV) nonstructural protein (NS)5B inhibitor being evaluated as treatment for chronic HCV infection.” PMID 30325939 ↗ Oct 2018 |
| Modality | Small molecule | “The nucleotide analog AL-335 is a pangenotypic hepatitis C virus (HCV) nonstructural protein (NS)5B inhibitor being evaluated as treatment for chronic HCV infection.” PMID 30325939 ↗ Oct 2018 |
| Route | Oral | “This three-part randomized, double-blind study evaluated the safety and pharmacokinetics of single and multiple ascending oral doses of AL-335.” PMID 30325939 ↗ Oct 2018 |