F/TAF

Phase 3Small molecule

Gilead

F/TAF is one of 9 small molecule programs targeting Tenofovir. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

TenofovirActive, not recruiting

TenofovirPhase 3

Active, not recruiting

Competition

Competitive Landscape

9 competitors in Tenofovir

#DrugCompanyPhaseTrials

Tybost

Gilead

Phase 3

6 2

B/F/TAF

Gilead

Phase 3

2 3

ISL/LEN

Gilead

Phase 3

1 4

PTM SEMA

Gilead

Phase 3

1 5

Cobicistat TOS

Gilead

Phase 3

1 6

Third Agent

Gilead

Phase 3

2 7

Lpv/r

Gilead

Phase 3

1 8

F/TAF

Gilead

Phase 3

1 9

Truvada

Gilead

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2/3Active, not recruiting

Tenofovir

NCT02016924

Q1 2028

Phase 3Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT04994509

Q3 2028

Phase 3Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT04925752

Q1 2034

ApprovedRecruiting

HIV-1 Infection

NCT06337032

Clinical

Trials by Indication[1]

Immunodeficiency3 trials

Switching to a Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Adults Who Are Virologically Suppressed

Completed· Gilead logo

Gilead·Phase 3·NCT03110380·567 enrolled

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Completed· Gilead logo

Gilead·Phase 3·NCT02607956·657 enrolled

Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen

Completed· Gilead logo

Gilead·Phase 2/3·NCT02285114·41 enrolled

HIV-12 trials

Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC

Completed· Gilead logo

Gilead·Phase 3·NCT02469246·567 enrolled

Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF

Completed· Gilead logo

Gilead·Phase 3·NCT02121795·668 enrolled

Pre-Exposure Prophylaxis of HIV Infection2 trials

A Phase 3, Double-Blinded, Multicenter, Randomized Study to Evaluate Safety and Efficacy of Twice Yearly Long-Acting Subcutaneous Lenacapavir, and Daily Oral Emtricitabine/Tenofovir Alafenamide for Pre-Exposure Prophylaxis in Adolescent Girls and Young Women at Risk of HIV Infection

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT04994509·5,368 enrolled

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT04925752·3,292 enrolled

Insulin Sensitivity1 trial

Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication

Completed·TTechnical University of Munich·Phase 1·NCT03092206·30 enrolled

Tenofovir1 trial

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Active, not recruiting· Gilead logo

Gilead·Phase 2/3·NCT02016924·133 enrolled

5 more indications

Interaction1 trial

Relative Bioavailability Study to Investigate a Potential Interaction Between DTG DT and F/TAF TOS.

Completed·RRadboud University Medical Center·Phase 1·NCT05489406·16 enrolled

Antiretroviral Treatment1 trial

Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Completed· Gilead logo

Gilead·Phase 2·NCT02397694·98 enrolled

Safety and Efficacy1 trial

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

Completed· Gilead logo

Gilead·Phase 2·NCT04143594·183 enrolled

HIV-1 infection1 trial

An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments

Recruiting· Gilead logo

Gilead·Approved·NCT06337032·350 enrolled

Pre-Exposure Prophylaxis of HIV-1 Infection1 trial

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

Terminated· Gilead logo

Gilead·Phase 3·NCT02842086·5,399 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for F/TAF. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — F/TAF compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for F/TAF. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Gilead

F/TAF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Q3 2028

Q1 2034

Trials by Indication[1]

Immunodeficiency3 trials

HIV-12 trials

Pre-Exposure Prophylaxis of HIV Infection2 trials

Insulin Sensitivity1 trial

Tenofovir1 trial

Interaction1 trial

Antiretroviral Treatment1 trial

Safety and Efficacy1 trial

HIV-1 infection1 trial

Pre-Exposure Prophylaxis of HIV-1 Infection1 trial

References

Drug Info

Quick Facts

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