TENOFOVIR DISOPROXIL FUMARATE
TENOFOVIR DISOPROXIL FUMARATE is indicated for the treatment of HIV-1 Infection; Chronic Hepatitis B.
How TENOFOVIR DISOPROXIL FUMARATE Works
Tenofovir disoproxil fumarate is a nucleotide analog reverse transcriptase inhibitor. It functions as an antiviral agent by inhibiting the activity of HIV-1 reverse transcriptase and HBV reverse transcriptase. By competing with natural substrates and causing DNA chain termination after incorporation into viral DNA, it blocks viral replication.
Details
- Status
- Prescription
- First Approved
- 2015-03-18
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TENOFOVIR DISOPROXIL FUMARATE Approval History
What TENOFOVIR DISOPROXIL FUMARATE Treats
2 indicationsTENOFOVIR DISOPROXIL FUMARATE is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
- Chronic Hepatitis B
TENOFOVIR DISOPROXIL FUMARATE Boxed Warning
BOXED WARNING WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. If appropriate, resumption of anti-h...
BOXED WARNING WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. If appropriate, resumption of anti-hepatitis B therapy may be warranted [See Warnings and Precautions ( 5.1 )]. WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely in these patients. If appropriate, resumption of anti-hepatitis B therapy may be warranted. (5.1)
TENOFOVIR DISOPROXIL FUMARATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to TENOFOVIR DISOPROXIL FUMARATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
36 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05652478 | 10000906 000906-I | Ph 2 | recruiting | Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study |
| NCT04704024 REVERT-B | IRB-300006586 5R01HD101545 | Ph 3 | active not recruiting | Reducing Vertical Transmission of Hepatitis B in Africa |
| NCT06356662 | KY-2023-198 | Ph 1 | recruiting | Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT04937881 PrEP-PP PK results posted | CO-US-412-6091 | Ph 3 | completed | PK of TAF and TDF for PrEP in Pregnant and Postpartum Women |
| NCT00799864 results posted | CR002677 TMC278-TiDP38-C213, 2008-001696-30 | Ph 2 | completed | A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years |
| NCT03887702 results posted | S1614 NCI-2018-00592, S1614 | Ph 3 | terminated | Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors |
| NCT04114890 PK-TDF | VIR19001 | Ph 2 | completed | Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B. |
| NCT02600117 | 15-8950 IN-CA-174-1708 | Ph 3 | completed | Use of TDF in Patients With Inactive Chronic Hepatitis B Infection |
| NCT02995005 | JHSPH-TDF | Ph 1, Ph 2 | completed | Tenofovir in Early Pregnancy to Prevent Mother-to-child Transmission of Hepatitis B Virus |
| NCT03485534 HBV | DW_TEN001 | Ph 4 | completed | Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients |
| NCT05355467 | Mylan-Ricovir-TW-01 | Ph 4 | completed | Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum |
| NCT02224456 results posted | 201213 | Ph 4 | completed | Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis |
| NCT01505114 results posted | HPTN 069/A5305 (NEXT Prep) 11789, HPTN 069/A5305 | Ph 2 | completed | Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women |
| NCT00705679 results posted | MTN-003 (VOICE) 10622, MTN-003 | Ph 2 | completed | Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women |
| NCT00592124 results posted | MTN-001 10617, 1U01AI068633-01 | Ph 2 | completed | Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women |
| NCT03241641 | IN-US-320-4390 | Ph 4 | completed | Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir. |
| NCT01745822 iTAP results posted | U01HD071889 U01HD071889 | Ph 3 | completed | Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand |
| NCT03567382 AVERT-HBV results posted | 17-2090 IGHID 11720 | Ph 4 | completed | Arresting Vertical Transmission of Hepatitis B Virus |
| NCT01709084 SALIF results posted | CR100875 TMC278IFD3002 | Ph 3 | completed | A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment |
| NCT03258710 results posted | 205883 | Ph 4 | completed | A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B |
| NCT02935075 OAT | 2016-M-1 | Ph 4 | completed | Optimization of Antiretroviral Therapy |
| NCT02195518 results posted | 201215 | Ph 4 | completed | Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study |
| NCT02174276 results posted | GS-US-330-1401 2014-001011-39 | Ph 2 | completed | Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment |
| NCT02908191 | ABI-H0731-101 | Ph 1 | completed | A Study in Healthy Volunteers and Patients With Chronic Hepatitis B |
| NCT03537404 results posted | CJ05013019 | Ph 1 | completed | A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs |
| NCT01379508 results posted | CLDT600A2409 2007-000180-13 | Ph 4 | completed | Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap Concept |
| NCT01671787 | GS-US-320-0101 | Ph 1 | completed | A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B |
| NCT03109730 | ABI-H0731-101B | Ph 1, Ph 2 | completed | Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B |
| NCT03032536 | AL-3778-1002 U1111-1187-4391 | Ph 1 | terminated | Study of the Relative Oral Bioavailability of AL-3778 Tablets and Drug Interaction With Entecavir or Tenofovir Disoproxil Fumarate in Healthy Volunteers |
| NCT01592305 | NP28104 | Ph 1 | completed | A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir |
| NCT01528865 | UMCC 2010 097 HUM 33361 | Ph 1, Ph 2 | withdrawn | Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma |
| NCT02670772 D4T | WRHI001 BMGF | Ph 3 | completed | Dose Optimisation of Stavudine for the Treatment of HIV Infection |
| NCT00903084 | R21MH085598 R21MH085598, DAHBR 9A-ASPQ | Ph 1 | completed | Examining Hair to Determine Tenofovir Exposure |
| NCT00736190 results posted | GS-US-174-0123 | Ph 4 | completed | A Study to Evaluate Tenofovir Disoproxil Fumarate (DF) in Asian-American Adults With Chronic Hepatitis B Infection |
| NCT00647244 SWAP | SKS-HIV-002 EudraCT2007-004372-39 | Ph 4 | completed | Efficacy and Safety of Switching From Retrovir to Tenofovir or Abacavir in HIV-infected Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TENOFOVIR DISOPROXIL FUMARATE FDA Label Details
Indications & Usage
FDA Label (PDF)TENOFOVIR DISOPROXIL FUMARATE is indicated for the treatment of HIV-1 Infection; Chronic Hepatitis B.
BOXED WARNING WARNING: POSTTREATMENT EXACERBATION OF HEPATITIS Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both c...
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Full clinical data, patents, trials, and competitive landscape for tenofovir disoproxil fumarate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.