Overview
Tenofovir is an acyclic nucleotide diester analog of adenosine monophosphate. In the most strict sense and due to the fact that it presents a phosphate group bound to the nitrogenous base, it is determined as an actual nucleotide analog. The antiviral activities of tenofovir were first reported in 1993 and this agent was commercially available since 2008 in the form of tenofovir disoproxil and tenofovir alafenamide in order to obtain oral bioavailability.
Background
Tenofovir is an acyclic nucleotide diester analog of adenosine monophosphate. In the most strict sense and due to the fact that it presents a phosphate group bound to the nitrogenous base, it is determined as an actual nucleotide analog. The antiviral activities of tenofovir were first reported in 1993 and this agent was commercially available since 2008 in the form of tenofovir disoproxil and tenofovir alafenamide in order to obtain oral bioavailability.
Indication
Tenofovir has been shown to be effective against HIV, herpes simplex virus-2, and hepatitis B virus. To know more about the specific product indications, please visit the information in the orally available forms of tenofovir, tenofovir alafenamide and tenofovir disoproxil.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/26 | N/A | Not yet recruiting | |||
2024/12/19 | Phase 4 | Active, not recruiting | Jiangsu Hansoh Pharmaceutical Co., Ltd. | ||
2024/11/27 | Not Applicable | ENROLLING_BY_INVITATION | |||
2024/09/19 | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | ||
2024/09/19 | Phase 2 | Not yet recruiting | Jongman Kim | ||
2024/07/19 | Phase 2 | Recruiting | |||
2024/03/06 | Phase 1 | Recruiting | |||
2024/09/24 | Phase III and phase IV (Integrated) | Recruiting | |||
2024/02/09 | Phase 3 | Recruiting | |||
2024/01/24 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Gilead Sciences, Inc. | 61958-2505 | ORAL | 15 mg in 1 1 | 2/28/2024 | |
| Gilead Sciences, Inc. | 61958-1901 | ORAL | 10 mg in 1 1 | 1/13/2022 | |
| Gilead Sciences, Inc. | 61958-2501 | ORAL | 25 mg in 1 1 | 2/28/2024 | |
| Gilead Sciences, Inc. | 61958-2101 | ORAL | 25 mg in 1 1 | 9/17/2021 | |
| Gilead Sciences, Inc. | 61958-2005 | ORAL | 15 mg in 1 1 | 1/20/2022 | |
| Gilead Sciences, Inc. | 61958-2506 | ORAL | 15 mg in 1 1 | 2/28/2024 | |
| A-S Medication Solutions | 50090-6247 | ORAL | 25 mg in 1 1 | 10/21/2022 | |
| Gilead Sciences, Inc. | 61958-2002 | ORAL | 25 mg in 1 1 | 1/20/2022 | |
| Gilead Sciences, Inc. | 61958-2301 | ORAL | 25 mg in 1 1 | 10/20/2022 | |
| A-S Medication Solutions | 50090-2340 | ORAL | 25 mg in 1 1 | 8/28/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/9/2017 | ||
Authorised | 1/9/2017 |
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||