Overview
A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia. [PubChem]
Background
A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia. [PubChem]
Indication
Used in combination with other antiretroviral agents for the treatment of human immunovirus (HIV) infections.
Associated Conditions
- HIV Transmission
- Human Immunodeficiency Virus (HIV) Infections
- Perinatal HIV transmission
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/10/24 | Not Applicable | Completed | |||
2008/10/24 | Not Applicable | Completed | |||
2008/07/21 | Early Phase 1 | Completed | International Maternal Pediatric Adolescent AIDS Clinical Trials Group | ||
2008/05/06 | Phase 1 | Completed | |||
2008/02/18 | Phase 4 | Completed | Peking Union Medical College | ||
2008/02/06 | Not Applicable | Completed | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | ||
2008/01/28 | Not Applicable | Completed | |||
2008/01/28 | Not Applicable | Completed | |||
2007/09/14 | Phase 3 | Completed | |||
2007/03/20 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Direct Rx | 61919-061 | ORAL | 300 mg in 1 1 | 6/22/2016 | |
| Rebel Distributors Corp | 21695-846 | ORAL | 300 mg in 1 1 | 5/12/2009 | |
| ViiV Healthcare Company | 49702-211 | ORAL | 100 mg in 1 1 | 11/5/2020 | |
| State of Florida DOH Central Pharmacy | 53808-0895 | ORAL | 300 mg in 1 1 | 2/27/2014 | |
| Aurobindo Pharma Limited | 65862-024 | ORAL | 300 mg in 1 1 | 1/25/2024 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||