Overview
A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. [PubChem]
Background
A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. [PubChem]
Indication
Indinavir is an antiretroviral drug for the treatment of HIV infection.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/02/11 | Phase 2 | Completed | Barbara Ensoli, MD, PhD | ||
2008/03/18 | Phase 2 | UNKNOWN | Oncology Institute of Southern Switzerland | ||
2006/08/10 | Phase 2 | Completed | |||
2005/09/20 | N/A | Completed | Harvard School of Public Health (HSPH) | ||
2005/09/19 | Phase 4 | Completed | |||
2005/09/12 | Phase 3 | Completed | French National Agency for Research on AIDS and Viral Hepatitis | ||
2005/07/22 | Not Applicable | Terminated | French National Agency for Research on AIDS and Viral Hepatitis | ||
2005/07/19 | Phase 2 | Terminated | French National Agency for Research on AIDS and Viral Hepatitis | ||
2003/07/11 | Phase 2 | Completed | |||
2002/12/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| STAT Rx USA LLC | 16590-064 | ORAL | 400 mg in 1 1 | 6/14/2012 | |
| Rebel Distributors Corp | 21695-366 | ORAL | 400 mg in 1 1 | 11/4/2008 | |
| State of Florida DOH Central Pharmacy | 53808-0661 | ORAL | 400 mg in 1 1 | 8/18/2010 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Indinavir Sulfate Capsules | 国药准字H20046715 | 化学药品 | 胶囊剂 | 6/4/2020 | |
| Indinavir Sulfate Capsules | 国药准字H20040970 | 化学药品 | 胶囊剂 | 4/7/2020 | |
| Indinavir sulfate Tablets | 国药准字H20050447 | 化学药品 | 片剂 | 4/9/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||