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Cabenuva

(Cabotegravir)

ApprovedSmall molecule

This medication is an injectable preventive treatment for HIV-1 infection that works by reducing the amount of virus in the blood. It belongs to a class of drugs called HIV integrase inhibitors and is given as a muscle injection once monthly for the first two months, then once every two months.[2] Cabenuva is currently approved and in use across 9 indications[4].[1]

Cabenuva is one of 251 small molecule programs targeting HIV infection. It is currently in Approved.

9

Indications

53

Total Trials

29

Active Trials

250

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

ImmunodeficiencyActive, not recruiting

HIVActive, not recruiting

Hepatitis BApproved

TuberculosisActive, not recruiting

HIV InfectionsNot yet recruiting

Opioid Use DisorderActive, not recruiting

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

ImmunodeficiencyPhase 3

Active, not recruiting

HIVApproved

Active, not recruiting

Hepatitis BApproved

Approved

TuberculosisPreclinical

Active, not recruiting

HIV InfectionsPhase 3

Not yet recruiting

Opioid Use DisorderApproved

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Cabenuva

Sunlenca

Intron a

Praluent

Hivid

CConrado Roberto Hoffmann Filho

Betaseron

Proleukin

IIovance Biotherapeutics, Inc.

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Buprenorphine/naloxone

PTM SEMA

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

Timeline

Expected Milestones

Q4 2026

Not yet recruiting

Outcome

NCT06403865

Phase 3Not yet recruiting

Prep

NCT06273943

Phase 3Recruiting

Outcome

NCT06507059

Q1 2027

Post-ApprovalRecruiting

HIV-1

NCT06646562

Phase 2Active, not recruiting

Treatment

NCT06411223

Active, not recruiting

Female

NCT06145854

Clinical

Trials by Indication[1]

Adult6 trials

Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT04484337·138 enrolled

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Recruiting· GSK logo

GSK·Phase 1·NCT05418868·214 enrolled

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT06033547·56 enrolled

Show 3 more trials

Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

Completed· GSK logo

GSK·Phase 1·NCT02478463·19 enrolled

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

Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT04371380·15 enrolled

Immunodeficiency6 trials

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

Active, not recruiting· GSK logo

GSK·Phase 3·NCT05917509·171 enrolled

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Active, not recruiting· GSK logo

GSK·Phase 3·NCT03299049·1,049 enrolled

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Completed· GSK logo

GSK·Phase 3·NCT04542070·687 enrolled

Show 3 more trials

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Completed· GSK logo

GSK·Phase 3·NCT05896748·94 enrolled

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Completed· GSK logo

GSK·Phase 3·NCT05896761·118 enrolled

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Active, not recruiting· GSK logo

GSK·Phase 2·NCT05996471·185 enrolled

HIV-14 trials

Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study

Not yet recruiting·PPomeranian Medical University Szczecin··NCT07370649·250 enrolled

Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03739996·75 enrolled

Improving HIV-1 Control in Africa with Long Acting Antiretrovirals

Active, not recruiting·MMRC/UVRI and LSHTM Uganda Research Unit·Phase 3·NCT05546242·540 enrolled

Show 1 more trial

Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

Recruiting·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 4·NCT06646562·120 enrolled

Pre-Exposure Prophylaxis (PrEP)3 trials

PrEPared to Choose (PtC) is an Implementation Study of the Delivery of Cabotegravir Long-acting, an Injectable Pre-exposure Prophylaxis (PrEP) Option for HIV Prevention. Injectable PrEP Will be Offered Alongside Oral and Vaginal Ring PrEP From Within a Real-world Context in Cape Town, South Africa.

Recruiting·DDesmond Tutu HIV Foundation··NCT06807736·1,800 enrolled

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

Acceptability and Feasibility of Injectable Cabotegravir Pre-exposure Prophylaxis (PrEP) Versus Oral PrEP in Routine Care up to 15 Months in Private Pharmacies in South Africa

Active, not recruiting·UUniversity of Witwatersrand, South Africa·Phase 3·NCT06138600·200 enrolled

Acceptability3 trials

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04692077·9 enrolled

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Females

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04824131·55 enrolled

Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa

Withdrawn·CCentre for the AIDS Programme of Research in South Africa·Phase 2·NCT02462772

24 more indications

Outcome2 trials

Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

Recruiting·—·Phase 3·NCT06507059·40 enrolled

Patient-Reported Outcomes in Real-life of Cabotegravir and Rilpivirine

Not yet recruiting·—··NCT06403865·280 enrolled

Prophylaxis2 trials

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

Not yet recruiting·MMRC/UVRI and LSHTM Uganda Research Unit·Phase 3·NCT06133686·400 enrolled

The Implementation of Pre-exposure Prophylaxis of Injectable Cabotegravir

Recruiting·EEvandro Chagas National Institute of Infectious Disease·Phase 3·NCT05515770·1,200 enrolled

Adolescent2 trials

Long-Acting Treatment in Adolescents (LATA)

Active, not recruiting·UUniversity College, London·Phase 3·NCT05154747·476 enrolled

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03497676·168 enrolled

PrEP2 trials

Impact of Long-acting Injectable Cabotegravir for HIV PrEP in MSM in France.

Not yet recruiting·AANRS, Emerging Infectious Diseases·Phase 3·NCT06273943·322 enrolled

Oregon PrEP at Home Study

Unknown status·OOregon Health and Science University··NCT05949203·125 enrolled

Women2 trials

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Completed· GSK logo

GSK·Phase 4·NCT05514509·370 enrolled

Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2/3·NCT02720094·4,570 enrolled

HIV Infections2 trials

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

Not yet recruiting· Gilead logo

Gilead·Phase 3·NCT07682961·590 enrolled

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

Recruiting· Gilead logo

Gilead··NCT07473778·3,000 enrolled

ART1 trial

A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV

Active, not recruiting·UUniversity Hospital Virgen de las Nieves··NCT06518408·287 enrolled

Phase II1 trial

Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir

Completed· GSK logo

GSK·Phase 1·NCT02345707·37 enrolled

Volume1 trial

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Completed· GSK logo

GSK·Phase 4·NCT05374525·287 enrolled

HIV1 trial

GSK1265744 (Cabotegravir, CAB) for Named Patient/Compassionate Use in HIV

Available· GSK logo

GSK··NCT03462810

Tuberculosis1 trial

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT04518228·205 enrolled

Cohort Study1 trial

Cohort Study of HIV-positive People, Treated With Long Acting Antiretroviral Therapy

Recruiting·CCastagna Antonella··NCT05663580·1,500 enrolled

Treatment1 trial

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

Active, not recruiting·YYale University·Phase 2·NCT06411223·50 enrolled

Pediatric1 trial

A Study to Assess the Food Effect and the Relative Bioavailability of the Cabotegravir (CAB) Pediatric Dispersible Tablet (DT) Formulation

Completed· GSK logo

GSK·Phase 1·NCT05776108·24 enrolled

Oral1 trial

Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT03149848·15 enrolled

Opioid Use Disorder1 trial

NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

Not yet recruiting·—·Phase 4·NCT06854029·300 enrolled

Efficacy1 trial

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Active, not recruiting· GSK logo

GSK·Phase 3·NCT02938520·631 enrolled

Breastfeeding1 trial

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Active, not recruiting·—·Phase 4·NCT05986084·500 enrolled

Liver1 trial

Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

Completed·KKelley-Ross & Associates, Inc.··NCT05867212·50 enrolled

HIV Prevention1 trial

SEARCH CAB LA Dynamic Choice HIV Prevention Study Extension

Completed·UUniversity of California, San Francisco·Phase 4·NCT05549726·984 enrolled

Treatment Failure1 trial

Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

Recruiting·UUniversity of Zurich··NCT06405464·600 enrolled

Female1 trial

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

Active, not recruiting·MMidway Specialty Care Center··NCT06145854·100 enrolled

Infection, Human Immunodeficiency Virus1 trial

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

Active, not recruiting· GSK logo

GSK·Phase 3·NCT02951052·618 enrolled

Unspecified2 trials

Kuwa Free! - Live Free!

Recruiting·UUniversity of Alabama at Birmingham·N/A·NCT05044962·700 enrolled

A Study to Evaluate the Effect of High Fat Meal on Cabotegravir

Completed· GSK logo

GSK·Phase 1·NCT02799264·24 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 21, 2021

VOCABRIA

NDA NDA212887

Dec 20, 2021

APRETUDE

NDA NDA215499

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Cabotegravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cabenuva drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cabotegravir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cabotegravir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215499). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cabenuva. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Cabotegravir. U.S. National Library of Medicine.
[8]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Integrase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GSK

Patent Landscape[6]

Patent #Expires

10927129Apr 28, 2026

Key Publications[7]

Long-Acting Cabotegravir for HIV Prevention: HPTN 084 Final Analysis

N Engl J MedJul 21, 2022DOI: 10.1056/NEJMoa2204629

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