Emtricitabine/tenofovir alafenamide

Phase 2Small molecule

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Emtricitabine/tenofovir alafenamide is one of 41 small molecule programs targeting Pre-Exposure Prophylaxis (PrEP). It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pre-Exposure Prophylaxis (prep)Active, not recruiting

AdultCompleted

Pre-Exposure Prophylaxis of HIV InfectionActive, not recruiting

Pre-Exposure Prophylaxis (prep)Phase 2

Active, not recruiting

AdultPreclinical

Completed

Pre-Exposure Prophylaxis of HIV InfectionPhase 2

Active, not recruiting

Competition

Competitive Landscape

127 competitors in Adult

#DrugCompanyPhaseTrials

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 2

Tebrazid

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

1 3

Mounjaro

Eli Lilly

Phase 2

1 4

Rifampicin

Boehringer Ingelheim

Phase 3

3 5

Myqorzo

CCytokinetics

Phase 3

1 6

Opzelura

DDizal Pharmaceuticals

Phase 2

1 7

NM8074

NNovelMed Therapeutics

Phase 2

2 8

EB-1020

Otsuka

Phase 3

1 9

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 1

1 10

Ansaid

PPharmacia and Upjohn

Phase 1

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

Timeline

Expected Milestones

Q1 2028

Phase 2Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT06101329

Phase 2Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT06101342

Q4 2028

Phase 2Active, not recruiting

Pre-Exposure Prophylaxis (prep)

NCT06513312

Q2 2029

Recruiting

HIV Infections

NCT07473778

Clinical

Trials by Indication[1]

Tenofovir Disoproxil Fumarate4 trials

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Completed·AAbbott·Phase 3·NCT00711009·206 enrolled

Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00118898·1,864 enrolled

Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00660972·40 enrolled

Show 1 more trial

Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00076791·66 enrolled

Tenofovir3 trials

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04661397·37 enrolled

Relative Bioavailability and Food Effect for Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02475135·72 enrolled

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat When Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04236453·16 enrolled

COVID-192 trials

TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)

Terminated·HHospital Italiano de Buenos Aires·Phase 3·NCT04405271·1,378 enrolled

Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19

Completed·IInstituto de Investigación Hospital Universitario La Paz·Phase 3·NCT04890626·356 enrolled

Drug2 trials

Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs

Completed·RRhonda Brand·Phase 1·NCT04302896·30 enrolled

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00074581·3,526 enrolled

Treatment2 trials

Rapid HIV Treatment Initiation, Access and Engagement in Care

Completed·JJohns Hopkins University·N/A·NCT03512964·32 enrolled

HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT00442962·54 enrolled

22 more indications

Prophylaxis2 trials

Post-Exposure Prophylaxis in Health Care Workers

Completed·HHenry Ford Health System·Phase 4·NCT01234116·16 enrolled

Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples

Completed·UUniversity of Washington·Phase 3·NCT00557245·4,758 enrolled

Recruiting· Gilead logo

Gilead··NCT07473778·3,000 enrolled

Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03048422·643 enrolled

Pre-Exposure Prophylaxis of HIV Infection2 trials

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

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

Infections1 trial

When to Start Anti-HIV Drugs in Patients With Opportunistic Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00055120·283 enrolled

Cardiovascular1 trial

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections··NCT00851799·334 enrolled

Prevention1 trial

A Key Link for Transmission Prevention

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01450189·46 enrolled

Bone1 trial

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00729573·518 enrolled

ART1 trial

Comparative Study of Three NNRTI-Sparing HAART Regimens

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00811954·1,814 enrolled

Liver Disease1 trial

Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.

Completed· Gilead logo

Gilead·Phase 2·NCT00298363·112 enrolled

Prospective1 trial

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT00084136·1,571 enrolled

Plasmodium Falciparum1 trial

Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 1/2·NCT01632891·52 enrolled

PrEP1 trial

PrEP Demonstration Project (PRELUDE Study)

Completed·KKirby Institute·Phase 4·NCT02206555·327 enrolled

HIV-1 infection1 trial

GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection

Completed· Roche logo

Roche·Phase 3·NCT00105079·337 enrolled

Women1 trial

NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00089505·745 enrolled

Hepatitis C1 trial

Effects of Anti-HIV Drugs on the Hepatitis C Virus (HCV) in Adults Infected With Both HCV and HIV

Completed·UUniversity of Cincinnati·Phase 1·NCT00545558·18 enrolled

HIV Prevention1 trial

Comprehensive HIV Prevention Package for MSM in Port Elizabeth

Completed·EEmory University·N/A·NCT02449733·101 enrolled

Pre-Exposure Prophylaxis (PrEP)1 trial

Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06513312·268 enrolled

Adult1 trial

Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·N/A·NCT00608569·529 enrolled

Acceptability1 trial

Project Engage: Oral PrEP Acceptability

Completed·—·Phase 2·NCT05458765·330 enrolled

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Emtricitabine/tenofovir alafenamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Emtricitabine/tenofovir alafenamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Emtricitabine/tenofovir alafenamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Emtricitabine/tenofovir alafenamide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q4 2028

Q2 2029

Trials by Indication[1]

Tenofovir Disoproxil Fumarate4 trials

Tenofovir3 trials

COVID-192 trials

Drug2 trials

Treatment2 trials

Prophylaxis2 trials

Pregnancy2 trials

Effectiveness2 trials

Combination Therapy2 trials

HIV Infections2 trials

Pre-Exposure Prophylaxis of HIV Infection2 trials

Infections1 trial

Cardiovascular1 trial

Prevention1 trial

Bone1 trial

ART1 trial

Liver Disease1 trial

Prospective1 trial

Plasmodium Falciparum1 trial

PrEP1 trial

HIV-1 infection1 trial

Women1 trial

Hepatitis C1 trial

HIV Prevention1 trial

Pre-Exposure Prophylaxis (PrEP)1 trial

Adult1 trial

Acceptability1 trial

References

Drug Info

Quick Facts

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