BIC/LEN FDC

Phase 3Small molecule

Gilead

BIC/LEN FDC is one of 78 small molecule programs targeting HIV-1 infection. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HIV-1 InfectionActive, not recruiting

AdolescentRecruiting

HIV-1 InfectionPreclinical

Active, not recruiting

AdolescentPhase 3

Recruiting

Competition

Competitive Landscape

66 competitors in HIV-1 Infection

#DrugCompanyPhaseTrials

Tybost

Gilead

Approved

1 2

Emtriva

Vemlidy

Renvela

Epidiolex

Cabenuva

Oncovin

Crestor

Bayer Aspirin

Niacor

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

Timeline

Expected Milestones

Q3 2028

PreclinicalActive, not recruiting

HIV-1 Infection

NCT05502341

Phase 2/3Recruiting

Adolescent

NCT06532656

Clinical

Trials by Indication[1]

Adolescent1 trial

Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Recruiting· Gilead logo

Gilead·Phase 2/3·NCT06532656·75 enrolled

HIV-1 infection1 trial

An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens

Active, not recruiting· Gilead logo

Gilead·Preclinical·NCT05502341·689 enrolled

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for BIC/LEN FDC. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BIC/LEN FDC compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BIC/LEN FDC. 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

BIC/LEN FDC

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Trials by Indication[1]

Adolescent1 trial

HIV-1 infection1 trial

References

Drug Info

Quick Facts

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