F/TDF

Phase 3Small molecule

Gilead

F/TDF is one of 7 small molecule programs targeting HIV Prevention. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HIV PreventionNot yet recruiting

Pre-Exposure Prophylaxis of HIV InfectionActive, not recruiting

HIV PreventionPhase 3

Not yet recruiting

Pre-Exposure Prophylaxis of HIV InfectionPhase 3

Active, not recruiting

Competition

Competitive Landscape

6 competitors in HIV Prevention

#DrugCompanyPhaseTrials

F/TDF

Gilead

Phase 3

1 2

Alhydrogel Adjuvant

NNational Institute of Allergy and Infectious Diseases (NIAID)

Phase 2

1 3

GLA-SE Adjuvant

NNational Institute of Allergy and Infectious Diseases (NIAID)

Phase 2

1 4

Pre-Exposure Prophylaxis (prep)

NNew York University

Preclinical

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

Timeline

Expected Milestones

Q1 2028

Phase 3Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT04994509

Phase 2Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT06101329

Phase 2Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT06101342

Q2 2028

ApprovedNot yet recruiting

HIV Prevention

NCT07901101

Q3 2028

Phase 3Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT04925752

Q2 2029

Recruiting

HIV Infections

NCT07473778

Clinical

Trials by Indication[1]

Pre-Exposure Prophylaxis of HIV Infection4 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

A Phase 2, Open-label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Acceptability of Twice Yearly Long-acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in Cisgender Women in the United States

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06101329·253 enrolled

Show 1 more trial

A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate the Pharmacokinetics and Safety of Twice Yearly Long-Acting Subcutaneous Lenacapavir for Pre-Exposure Prophylaxis in People Who Inject Drugs

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06101342·181 enrolled

Hepatitis B1 trial

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Completed· Gilead logo

Gilead·Phase 3·NCT03547908·244 enrolled

HIV Prevention1 trial

RAPID Response (Revolutionary Access to PrEP In the ED): A Pilot Implementation Study of Peer Navigator-Facilitated, Same-Visit Initiation of Oral HIV Pre-Exposure Prophylaxis in the Emergency Department

Not yet recruiting·UUniversity of South Florida·Approved·NCT07901101·50 enrolled

HIV Infections1 trial

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)

Recruiting· Gilead logo

Gilead··NCT07473778·3,000 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 — 8 trial records for F/TDF. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — F/TDF compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for F/TDF. 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/TDF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q2 2028

Q3 2028

Q2 2029

Trials by Indication[1]

Pre-Exposure Prophylaxis of HIV Infection4 trials

Hepatitis B1 trial

HIV Prevention1 trial

HIV Infections1 trial

Pre-Exposure Prophylaxis of HIV-1 Infection1 trial

References

Drug Info

Quick Facts

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