BIC/FTC/TAF

Phase 3Small molecule

Merck & Co.

BIC/FTC/TAF is one of 44 small molecule programs targeting Immunodeficiency. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

ImmunodeficiencyActive, not recruiting

Human Immunodeficiency Virus Type 1 (HIV-1) InfectionRecruiting

ImmunodeficiencyPhase 3

Active, not recruiting

Human Immunodeficiency Virus Type 1 (HIV-1) InfectionPreclinical

Recruiting

Competition

Competitive Landscape

296 competitors in Immunodeficiency

#DrugCompanyPhaseTrials

Repatha

Amgen

Phase 3

1 2

Farxiga

AstraZeneca

Phase 3

1 3

Emtriva

Gilead

Phase 3

1 4

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

8 5

Edurant Ped

WWim Janssens

Phase 3

8 6

Vemlidy

Livalo

1 8

Immunoglobulin

Sanofi

Phase 3

2 9

Atripla

Gilead

Phase 3

3 10

PPSV23

Merck & Co.

Phase 3

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

Timeline

Expected Milestones

Q3 2028

Phase 3Recruiting

Overweight

NCT07075146

Phase 3Active, not recruiting

Immunodeficiency

NCT05630755

Q3 2029

Phase 3Active, not recruiting

Antiretroviral Treatment

NCT05705349

Q2 2030

PreclinicalRecruiting

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

NCT07266831

Q3 2031

Phase 2Active, not recruiting

Immunodeficiency

NCT06891066

Clinical

Trials by Indication[1]

Immunodeficiency5 trials

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04564547·161 enrolled

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06891066·150 enrolled

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04223791·643 enrolled

Show 2 more trials

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT05630755·514 enrolled

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04233879·599 enrolled

Clinical Trial1 trial

Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)

Completed·CCarmen Hidalgo Tenorio·Phase 4·NCT06177574·208 enrolled

Antiretroviral Treatment1 trial

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT05705349·537 enrolled

Weight Gain1 trial

Doravirine and Weight Gain in Antiretroviral Naive

Withdrawn·PPrism Health North Texas·Phase 3·NCT05457530

Overweight1 trial

DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or Obesity

Recruiting·JJosé Antonio Mata Marín·Phase 3·NCT07075146·306 enrolled

1 more indication

Human Immunodeficiency Virus Type 1 (HIV-1) Infection1 trial

A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07266831·570 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for BIC/FTC/TAF. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BIC/FTC/TAF compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BIC/FTC/TAF. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Merck & Co.

BIC/FTC/TAF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q3 2029

Q2 2030

Q3 2031

Trials by Indication[1]

Immunodeficiency5 trials

Clinical Trial1 trial

Antiretroviral Treatment1 trial

Weight Gain1 trial

Overweight1 trial

Human Immunodeficiency Virus Type 1 (HIV-1) Infection1 trial

References

Drug Info

Quick Facts

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