Product Description
Adafosbuvir (AL 335), a monophosphate prodrug, is being developed by Alios BioPharma (a subsidiary of Johnson & Johnson) for the treatment of hepatitis C virus (HCV) infections. Adafosbuvir acts a uridine-based nucleotide analogue polymerase inhibitor. (Sourced from: https://newdrugapprovals.org/tag/alios-biopharma/)
Mechanisms of Action: HCV-NS5B Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Hepatitis C, Chronic|Hepatitis A
Phase 1: Healthy Volunteers|Kidney Diseases|Other|Hepatitis C, Chronic|Hepatitis A
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| JapicCTI-163468 | P2 |
Completed |
Hepatitis C, Chronic |
2018-06-30 |
|
| 2016-002845-46 | P2 |
Completed |
Hepatitis C, Chronic |
2018-05-11 |
|
| AL-335-604 | P2 |
Completed |
Hepatitis C, Chronic |
2018-05-11 |
44% |
| CR108264 | P2 |
Completed |
Hepatitis C, Chronic|Hepatitis A |
2018-05-07 |
54% |
| CR108294 | P1 |
Withdrawn |
Other |
2017-12-22 |
|
| 2015-004200-38 | P2 |
Completed |
Hepatitis C, Chronic |
2017-11-16 |
|
| CR108332 | P1 |
Completed |
Healthy Volunteers |
2017-10-27 |
|
| CR108070 | P2 |
Completed |
Hepatitis C, Chronic|Hepatitis A |
2017-08-09 |
|
| CR108225 | P1 |
Completed |
Kidney Diseases |
2017-08-08 |
|
| CR108273 | P1 |
Terminated |
Healthy Volunteers |
2017-04-24 |
|
| CR108177 | P1 |
Completed |
Healthy Volunteers |
2016-12-01 |
|
| CR108179 | P1 |
Completed |
Healthy Volunteers |
2016-10-01 |
|
| CR108178 | P1 |
Completed |
Healthy Volunteers |
2016-09-09 |
|
| AL-335-601 | P1 |
Completed |
Hepatitis C, Chronic|Hepatitis A |
2016-05-31 |
|
| AL-335-602 | P1 |
Completed |
Hepatitis C, Chronic |
2015-08-31 |