CAB LA

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Safety and EfficacyAdultHIVHIV InfectionsInfection, Human Immunodeficiency Virus

131 competitors in Safety and Efficacy

#DrugCompanyPhaseTrials

1

Avastin

Roche

Phase 3

32

Actemra

Roche

Phase 3

13

Rayos

RRoxane Laboratories

Phase 3

34

Humira

RRanbaxy Laboratories Limited

Phase 3

35

Empaveli

Apellis Pharmaceuticals

Phase 3

26

Gemzar

Johnson & Johnson

Phase 2

67

Cytosar

Teva

Phase 2

38

Tagrisso

AstraZeneca

Phase 2

39

B/F/TAF

Gilead

Phase 3

510

Eloxatin

Teva

Phase 2

2Show 38 more competitors

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

HIV Infections6 trials

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention

Recruiting·UUniversity of Alabama at Birmingham··NCT07516548·105 enrolled

A Phase 2b Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of A New Formulation of Cabotegravir LA Injected Intramuscularly Q4M in Adolescent and Adult Participants at Risk of HIV Acquisition

Active, not recruiting·GSK·Phase 2·NCT06741397·229 enrolled

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)

Active, not recruiting·GSK·Phase 3·NCT06694805·326 enrolled

Show 3 more trials

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART

Recruiting·GSK·Phase 3·NCT07650916·564 enrolled

A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants

Active, not recruiting·GSK·Phase 3·NCT02938520·631 enrolled

A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

Active, not recruiting·GSK·Phase 3·NCT06134362·2,996 enrolled

Immunodeficiency4 trials

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Completed·GSK·Phase 3·NCT04399551·437 enrolled

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Completed·GSK·Phase 2·NCT02120352·309 enrolled

A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men

Completed·GSK·Phase 1·NCT03422172·48 enrolled

Show 1 more trial

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

Completed·GSK·Phase 2·NCT03639311·97 enrolled

Acceptability2 trials

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, 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

Women1 trial

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

ART1 trial

A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

Completed·Johnson & Johnson·Phase 1·NCT05112939·126 enrolled

5 more indications

Adult1 trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults

Active, not recruiting·GSK·Phase 1·NCT06786520·69 enrolled

Safety and Efficacy1 trial

Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT03164564·3,224 enrolled

Pregnancy1 trial

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT06336434

HIV1 trial

CHIPP-PrEP: Cabotegravir-Hormone Interrogation of Pharmacokinetics/Pharmacodynamics (PK/PD) for HIV Prevention

Recruiting·JJohns Hopkins University·Phase 1·NCT07672717·32 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·Phase 3·NCT02951052·618 enrolled

Details

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