Sunlenca

(Lenacapavir)

ApprovedSmall molecule

Lenacapavir is used to treat HIV infection in adults who have tried multiple other HIV medications and developed resistance to them. It works by blocking a protein that HIV needs to multiply and spread in the body.[2] Sunlenca is currently approved and in use across 12 indications[4].[1]

Sunlenca is one of 235 small molecule programs targeting Viral Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

234

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Viral DiseaseActive, not recruiting

HIV-1 InfectionRecruiting

ImmunodeficiencyCompleted

Hepatitis BApproved

AdolescentRecruiting

HIV Pre-Exposure ProphylaxisActive, not recruiting

HIV InfectionsRecruiting

HIV-1Active, not recruiting

AdultActive, not recruiting

Pre-Exposure Prophylaxis of HIV InfectionActive, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionPhase 3

Recruiting

ImmunodeficiencyPhase 1

Completed

Hepatitis BApproved

Approved

AdolescentPhase 2

Recruiting

HIV Pre-Exposure ProphylaxisPhase 3

Active, not recruiting

HIV InfectionsPhase 3

Recruiting

HIV-1Phase 3

Active, not recruiting

AdultPhase 1

Active, not recruiting

Pre-Exposure Prophylaxis of HIV InfectionPhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

120 competitors in Adult

#DrugCompanyPhaseTrials

Sunlenca

Gilead

Approved

1 2

Tebrazid

AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Phase 3

1 3

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 4

Mounjaro

Eli Lilly

Phase 2

1 5

Rifampicin

Boehringer Ingelheim

Phase 3

3 6

Opzelura

DDizal Pharmaceuticals

Phase 2

1 7

Briviact

UCB

Phase 1

1 8

NM8074

NNovelMed Therapeutics

Phase 2

2 9

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 1

1 10

Hytrin

AAbbott

Phase 1

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Adolescent

NCT06749054

Post-ApprovalRecruiting

Liver

NCT07210125

Q3 2027

ApprovedRecruiting

HIV Prevention

NCT07218211

Q4 2027

Not yet recruiting

Liver

NCT07467018

Q1 2028

Phase 3Active, not recruiting

Pre-Exposure Prophylaxis of HIV Infection

NCT04994509

PreclinicalActive, not recruiting

HIV-1 Infection

NCT04150068

Clinical

Trials by Indication[1]

HIV-1 infection10 trials

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT05729568·83 enrolled

Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Completed· Gilead logo

Gilead·Phase 1·NCT04811040·32 enrolled

Phase 4, Randomized, Open-label, Non-inferiority Trial of Bictegravir/Lenacapavir Fixed-dose Combination (BIC/LEN FDC) Versus Stable Baseline Regimens (SBR) in Virologically Suppressed (VS) People With HIV (PWH)

Not yet recruiting· Gilead logo

Gilead·Approved·NCT07908446·400 enrolled

Show 7 more trials

A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1

Recruiting· Gilead logo

Gilead·Phase 2·NCT07841990·125 enrolled

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

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

Recruiting· Gilead logo

Gilead·Phase 2·NCT07645287·175 enrolled

An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

Recruiting· Gilead logo

Gilead·Preclinical·NCT07708727·700 enrolled

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance

Active, not recruiting· Gilead logo

Gilead·Preclinical·NCT04150068·72 enrolled

A Phase 2/3, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1

Active, not recruiting· Gilead logo

Gilead·Preclinical·NCT06532656·75 enrolled

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir Twice-Yearly in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens

Recruiting· Gilead logo

Gilead·Phase 3·NCT07683000·590 enrolled

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

Pre-Exposure Prophylaxis (PrEP)2 trials

ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.

Not yet recruiting·DDesmond Tutu HIV Foundation··NCT07390409·3,700 enrolled

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

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06513312·268 enrolled

Immunodeficiency2 trials

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults

Completed· Gilead logo

Gilead·Phase 1·NCT03739866·53 enrolled

Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06819176·50 enrolled

Liver2 trials

Mobile Vehicle-Based Delivery of Lenacapavir PrEP in Los Angeles County

Not yet recruiting·UUniversity of California, Los Angeles··NCT07467018·100 enrolled

Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting

Recruiting·KKelley-Ross & Associates, Inc.·Phase 4·NCT07210125·75 enrolled

8 more indications

HIV Infections2 trials

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

Recruiting· Gilead logo

Gilead··NCT07473778·3,000 enrolled

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Recruiting· Gilead logo

Gilead·Phase 3·NCT07682961·590 enrolled

Adult1 trial

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

Active, not recruiting· GSK logo

GSK·Phase 1·NCT06970223·65 enrolled

HIV-11 trial

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT06333808·577 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

NAC1 trial

Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France

Recruiting·CCentre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida··NCT06799338·80 enrolled

Adolescent1 trial

Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children

Recruiting· Gilead logo

Gilead·Phase 2·NCT06749054·12 enrolled

HIV Prevention1 trial

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

Recruiting·DDuke University·Approved·NCT07218211·100 enrolled

HIV Pre-Exposure Prophylaxis1 trial

A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT07047716·339 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 22, 2022

SUNLENCA

NDA NDA215974

Dec 22, 2022

SUNLENCA

NDA NDA215973

Dec 22, 2022

SUNLENCA

NDA NDA215974

Dec 22, 2022

SUNLENCA

NDA NDA215973

Jul 17, 2024

SUNLENCA

NDA NDA215974

Jul 17, 2024

SUNLENCA

NDA NDA215973

Nov 13, 2024

SUNLENCA

NDA NDA215974

Nov 13, 2024

SUNLENCA

NDA NDA215973

Nov 25, 2024

SUNLENCA

NDA NDA215973

Nov 25, 2024

SUNLENCA

NDA NDA215974

Jun 18, 2025

YEZTUGO

NDA NDA220018

Jun 18, 2025

YEZTUGO

NDA NDA220020

Mar 12, 2026

SUNLENCA

NDA NDA215974

Mar 12, 2026

SUNLENCA

NDA NDA215973

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Lenacapavir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Sunlenca drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lenacapavir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lenacapavir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215974). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Sunlenca. U.S. Food & Drug Administration.
[7]
PubMed — 10 publications indexed for Lenacapavir. U.S. National Library of Medicine.
[8]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: HIV Capsid Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Gilead

Patent Landscape[6]

Patent Cliff

Feb 28, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9951043Feb 28, 2034

10654827Aug 17, 2037

10071985Aug 17, 2037

11267799Aug 16, 2038

12594267Jul 15, 2039

2 more patents

11807625Nov 25, 2040

11944611Aug 28, 2041

Key Publications[7]

Sequence-structure cross-attention model integrating ESM-2 embeddings and AlphaFold cues for accurate prediction of Escherichia coli protein solubility.

Comput Biol MedJun 23, 2026DOI: 10.1016/j.compbiomed.2026.111821

Virtual Reality-Delivered Exposure for Contamination Concerns in Adults With Obsessive-Compulsive Symptoms: Single-Arm Pilot Study.

JMIR Serious GamesJun 23, 2026DOI: 10.2196/78169

Luteolin attenuates vascular-renal dysfunction and fibrosis in hypertensive rats by targeting oxidative stress, inflammation, and fibrotic pathways.

Biomed PharmacotherJun 23, 2026DOI: 10.1016/j.biopha.2026.119701

Synergistic integration of ripple filter and penumbra reduction for enhanced dose conformity and beam delivery efficiency in proton therapy.

Phys MedJun 23, 2026DOI: 10.1016/j.ejmp.2026.105865

GLP-1 receptor agonist-induced transient retinal perfusion delay and its potential mediation by intracranial pressure.

Biomed PharmacotherJun 23, 2026DOI: 10.1016/j.biopha.2026.119635

Retrospective patient-specific intravascular brachytherapy dosimetry using optical coherence tomography imaging.

Phys MedJun 23, 2026DOI: 10.1016/j.ejmp.2026.105858

Infection site modifies the prognostic impact of disseminated intravascular coagulation in sepsis.

Thromb ResJun 23, 2026DOI: 10.1016/j.thromres.2026.109761

Reducing patient-specific QA workload through statistical process control and complexity metrics.

Phys MedJun 23, 2026DOI: 10.1016/j.ejmp.2026.105863

Experimental measurement of k(Q) values for 150 MeV proton beams in the middle of SOBP using water calorimetry and comparison with TRS-398 rev.1.

Phys MedJun 23, 2026DOI: 10.1016/j.ejmp.2026.105838

Implementation and Evaluation of a Social Networking Service-Based Mobile Patient-Generated Health Data System With Direct Electronic Medical Record Integration: Prospective Observational Study.

JMIR Med InformJun 23, 2026DOI: 10.2196/81317

Sunlenca

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

HIV-1 infection10 trials

Pre-Exposure Prophylaxis of HIV Infection4 trials

Pre-Exposure Prophylaxis (PrEP)2 trials

Immunodeficiency2 trials

Liver2 trials

HIV Infections2 trials

Adult1 trial

HIV-11 trial

Safety and Efficacy1 trial

NAC1 trial

Adolescent1 trial

HIV Prevention1 trial

HIV Pre-Exposure Prophylaxis1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

Related News