Lenacapavir

Summary

Lenacapavir (CHEMBL4594438) is an approved small molecule (ATC J05AX31); indicated across 3 conditions including viral infectious disease and hiv infectious disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: J05AX31
• Indications: 3 conditions
• Clinical trials: 26
• Chemistry: 968.3 Da · C39H32ClF10N7O5S2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4594438
Name	Lenacapavir
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	133082658
ATC	J05AX31
Molecular formula	C39H32ClF10N7O5S2
Molecular weight	968.3
InChIKey	BRYXUCLEHAUSDY-WEWMWRJBSA-N

SMILES: CC(C)(C#CC1=NC(=C(C=C1)C2=C3C(=C(C=C2)Cl)C(=NN3CC(F)(F)F)NS(=O)(=O)C)[C@H](CC4=CC(=CC(=C4)F)F)NC(=O)CN5C6=C([C@H]7C[C@H]7C6(F)F)C(=N5)C(F)(F)F)S(=O)(=O)C

IUPAC name: N-[(1S)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)-2-pyridinyl]-2-(3,5-difluorophenyl)ethyl]-2-[(2S,4R)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetamide

Also known as: GS-6207, GS-714207, GS-CA-2, GS-CA1, GS-CA2, GS-HIV, GS6207, Lenacapavir, LENACAPAVIR

Parent form; salt/anhydrous children: CHEMBL4802249

Patent coverage: 183 distinct patent families (549 SureChEMBL compound mentions), from 4 matched compound structure(s). One matched structure accounts for 367 (67%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

3 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
viral infectious disease	4	MONDO:0005108	EFO:0000763
HIV infectious disease	3	MONDO:0005109	EFO:0000180

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 26.

Phase distribution

Phase	Trials
PHASE2	6
PHASE2/PHASE3	5
Not specified	5
PHASE3	4
PHASE1	4
PHASE4	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07210125	PHASE4	ACTIVE_NOT_RECRUITING	Implementation and Deliver of Lenacapavir for PrEP in a Community Pharmacy Setting
NCT07218211	PHASE4	RECRUITING	Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
NCT04150068	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
NCT04925752	PHASE3	ACTIVE_NOT_RECRUITING	Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection
NCT04994509	PHASE3	ACTIVE_NOT_RECRUITING	Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
NCT05502341	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
NCT06333808	PHASE3	ACTIVE_NOT_RECRUITING	Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
NCT06532656	PHASE2/PHASE3	RECRUITING	Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1
NCT06544733	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
NCT07047716	PHASE3	RECRUITING	Study of Lenacapavir as a Once-Yearly Injection for HIV Pre-exposure Prophylaxis (PrEP)
NCT06613685	PHASE2/PHASE3	TERMINATED	Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
NCT05729568	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
NCT06101329	PHASE2	ACTIVE_NOT_RECRUITING	Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)
NCT06101342	PHASE2	ACTIVE_NOT_RECRUITING	Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)
NCT06513312	PHASE2	ACTIVE_NOT_RECRUITING	Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP)
NCT06749054	PHASE2	RECRUITING	Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children
NCT04143594	PHASE2	COMPLETED	Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV
NCT06819176	PHASE1	RECRUITING	Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
NCT06970223	PHASE1	ACTIVE_NOT_RECRUITING	A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
NCT03739866	PHASE1	COMPLETED	Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
NCT04811040	PHASE1	COMPLETED	Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
NCT06799338	Not specified	RECRUITING	Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France
NCT07390409	Not specified	NOT_YET_RECRUITING	ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.
NCT07467018	Not specified	RECRUITING	Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County
NCT07473778	Not specified	RECRUITING	Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
NCT07497594	Not specified	RECRUITING	ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).