Data updated: Jun 28, 2026
TENOFOVIR ALAFENAMIDE (tenofovir alafenamide fumarate)
Trial Activity: Stable 6 active trials
Infectious Disease
Approved 2023-03-30
Development Insights
Janssen Research & Development, LLC conducting 2 trials (11%)
18 indications explored (Broad Platform)
→ hiv (3 trials)
→ chronic hepatitis b (3 trials)
→ hepatitis b, chronic (3 trials)
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-03-30
- Routes
- ORAL
- Dosage Forms
- TABLET
TENOFOVIR ALAFENAMIDE Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
What TENOFOVIR ALAFENAMIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2023)Letter
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Clinical Trial Registry
18 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 |
| NCT05979311 VOGUE | 219816 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy |
| NCT04891770 results posted | GS-US-465-4439 2021-000672-11 | Ph 2 | completed | Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB) |
| NCT04439539 results posted | CR108815 73763989PAHPB2005, 2019-004978-26 | Ph 2 | completed | A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection |
| NCT05275023 OCTOPUS-1 results posted | CR109161 73763989PAHPB2008, 2021-005132-33 | Ph 2 | completed | An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants |
| NCT03804372 CLL1818 | CLL1818 | Ph 2 | terminated | The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide |
| NCT03933384 | CF18341A 106DHA0500150 | Ph 4 | recruiting | Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B |
| NCT03753074 ATTENTION | IN-KR-320-5358 | Ph 4 | active not recruiting | Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines |
| NCT04619082 | IRB2020091 | Ph 4 | active not recruiting | TAF to Prevent HBV Reactivation in Cancer Patients |
| 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 |
| NCT03510468 results posted | 180087 18-CC-0087 | Ph 1 | completed | Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA) |
| 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 |
| NCT03471624 results posted | 45054 | Ph 4 | completed | Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF) |
| NCT03122262 ADVANCE | WRHI060 | Ph 3 | completed | ADVANCE Study of DTG + TAF + FTC vs DTG + TDF + FTC and EFV + TDF+FTC in First-line Antiretroviral Therapy |
| 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. |
| NCT03489239 | 11729 | Ph 3 | active not recruiting | Entecavir to TAF Switch |
| NCT03115736 | INSEL-HINF-2017-1 | Ph 2 | completed | TAF for HIV-HBV With Renal Dysfunction |
| NCT02904369 | A15-137 | Ph 1 | completed | PK and PD Study of Oral F/TAF for HIV Prevention |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 ALAFENAMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment