Overview
Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 .
Indication
Tenofovir disoproxil is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients ≥2 years old and weighing ≥10 kg. It is also indicated for the treatment of chronic hepatitis B in patients ≥2 years old and weighing ≥10 kg. Tenofovir disoproxil is also an ingredient in several combination products, all of which are indicated either alone or in combination with other antiretrovirals for the treatment of HIV-1 infection. In addition, tenofovir disoproxil is available in combination with emtricitabine (under the brand name Truvada) for use as pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing ≥ 35kg to reduce the risk of sexually-acquired HIV-1 infection.
Associated Conditions
- Chronic Hepatitis B Infection
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/09 | Phase 2 | Not yet recruiting | |||
2024/10/22 | Phase 4 | Recruiting | Oslo University Hospital | ||
2024/09/19 | N/A | Not yet recruiting | Mohamed Nasr | ||
2024/09/06 | N/A | Recruiting | Oslo University Hospital | ||
2024/08/27 | N/A | Completed | Yaşar Bayındır, MD | ||
2024/04/10 | Phase 1 | Recruiting | The Fourth Affiliated Hospital of Zhejiang University School of Medicine | ||
2023/01/27 | N/A | Recruiting | |||
2023/01/13 | N/A | NO_LONGER_AVAILABLE | |||
2024/10/15 | Phase 2 | Active, not recruiting | |||
2022/06/27 | Phase 2 | Not yet recruiting | Sun Yat-sen University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6821 | ORAL | 300 mg in 1 1 | 8/16/2019 | |
| Strides Pharma Science Limited | 64380-714 | ORAL | 300 mg in 1 1 | 12/1/2019 | |
| A-S Medication Solutions | 50090-0870 | ORAL | 300 mg in 1 1 | 6/30/2020 | |
| DOH CENTRAL PHARMACY | 53808-1128 | ORAL | 300 mg in 1 1 | 1/24/2019 | |
| AvKARE | 42291-439 | ORAL | 300 mg in 1 1 | 1/9/2024 | |
| A-S Medication Solutions | 50090-6494 | ORAL | 300 mg in 1 1 | 12/31/2020 | |
| Aurobindo Pharma Limited | 59651-167 | ORAL | 250 mg in 1 1 | 1/3/2024 | |
| Chartwell RX, LLC. | 62135-466 | ORAL | 300 mg in 1 1 | 12/12/2022 | |
| RPK Pharmaceuticals, Inc. | 53002-1653 | ORAL | 300 mg in 1 1 | 7/5/2023 | |
| Camber Pharmaceuticals, Inc. | 31722-560 | ORAL | 300 mg in 1 1 | 2/14/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 2/20/2005 | ||
Authorised | 5/24/2013 | ||
Authorised | 11/27/2011 | ||
Authorised | 11/22/2018 | ||
Authorised | 2/4/2002 | ||
Authorised | 12/8/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| TENOF TENOFOVIR DISOPROXIL FUMARATE FILM-COATED TABLETS 300 MG | SIN15564P | TABLET, FILM COATED | 300mg | 10/19/2018 | |
| COMPLERA FILM-COATED TABLET 200MG/25MG/300MG | SIN14965P | TABLET, FILM COATED | 300 mg | 2/29/2016 | |
| VIRCLEAN F.C. TABLETS 300MG | SIN16078P | TABLET, FILM COATED | 300 mg | 1/6/2021 | |
| Truvada Tablet 200mg/300mg | SIN14147P | TABLET, FILM COATED | 300mg | 5/14/2012 | |
| Viread Tablets 300mg | SIN13938P | TABLET, FILM COATED | 300 mg | 3/28/2011 | |
| VIRKIL FILM-COATED TABLETS 300 MG | SIN15936P | TABLET, FILM COATED | 300 mg | 5/8/2020 | |
| HOVID TENOFOVIR DISOPROXIL FUMARATE FILM COATED TABLET 300MG | SIN16566P | TABLET, FILM COATED | 300mg | 8/5/2022 | |
| DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG | SIN15909P | TABLET, FILM COATED | 300.0mg | 3/13/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate Capsules | 国药准字H20170005 | 化学药品 | 胶囊剂 | 5/5/2022 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20203705 | 化学药品 | 片剂 | 12/25/2020 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20213261 | 化学药品 | 片剂 | 4/7/2021 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20173185 | 化学药品 | 片剂 | 12/24/2021 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20223081 | 化学药品 | 片剂 | 2/23/2022 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20203390 | 化学药品 | 片剂 | 8/5/2020 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20203461 | 化学药品 | 片剂 | 9/2/2020 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20193087 | 化学药品 | 片剂 | 11/30/2023 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20193020 | 化学药品 | 片剂 | 12/20/2023 | |
| Tenofovir Disoproxil Fumarate Tablets | 国药准字H20193042 | 化学药品 | 片剂 | 9/1/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APO-TENOFOVIR TABLETS 300MG | N/A | N/A | N/A | 3/26/2025 |
TGA Drug Approvals
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