Cabotegravir

Overview

Cabotegravir, or GSK1265744, is an HIV-1 integrase inhibitor that is prescribed with the non-nucleoside reverse transcriptase inhibitor, rilpivirine. Early research into cabotegravir showed it had lower oral bioavailability than dolutegravir, which resulted in the development of long acting monthly intramuscular injection formulation for cabotegravir. Cabotegravir was granted FDA approval on 21 January 2021 in combination with rilpivirine to treat HIV-1 infection in virologically suppressed individuals. While previously administered once monthly only, this combination product was granted FDA approval for dosing every two months on February 01, 2022 and without the need for an oral lead-in period prior.

Indication

Oral cabotegravir is indicated in combination with rilpivirine for the short-term treatment of HIV-1 in virologically suppressed adults with no history of treatment failure to assess tolerability of cabotegravir or who have missed an injected dose of cabotegravir. Intramuscular extended-release cabotegravir in combination with rilpivirine is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. An extended-release injectable suspension formulation of cabotegravir is also indicated for the prevention of sexually-acquired HIV-1 infection (i.e. for pre-exposure prophylaxis, PrEP) in at-risk adults and adolescents weighing at least 35kg.

Associated Conditions

Human Immunodeficiency Virus Type 1 (HIV-1)
Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings	2025/03/03	NCT06854029	Phase 4	Not yet recruiting	Duke University
Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.	2024/10/17	NCT06646562	Phase 4	Recruiting	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV	2024/07/24	NCT06518408	N/A	Active, not recruiting	University Hospital Virgen de las Nieves
HIV Prevention and Care Interventions for Youth in Uganda	2024/06/25	NCT06474364	Phase 4	Not yet recruiting	MU-JHU CARE
Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures	2024/05/08	NCT06405464	N/A	Recruiting	University of Zurich
Impact of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis persistence and coverage in men who have sex with men in France: a randomized controlled clinical trial.	2024/09/24	2024-510678-25-00	Phase III and phase IV (Integrated)	Recruiting	Inserm
Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT	2024/02/09	NCT06250504	Phase 3	Recruiting	Africa Health Research Institute
Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP	2023/11/24	NCT06145854	N/A	Recruiting	Midway Specialty Care Center
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	2023/11/18	NCT06138600	Phase 3	Active, not recruiting	University of Witwatersrand, South Africa
Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa	2023/11/15	NCT06133686	Phase 3	Not yet recruiting	MRC/UVRI and LSHTM Uganda Research Unit

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Vocabria	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	12/17/2020
Apretude	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	9/15/2023
Vocabria	ViiV Healthcare B.V.,Van Asch van Wijckstraat 55 H,3811 LP Amersfoort,The Netherlands	Authorised	12/17/2020

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VOCABRIA FILM-COATED TABLETS 30MG	Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Glaxo Wellcome, S.A. (Primary and Secondary Packaging)	SIN16541P	TABLET, FILM COATED	30mg	7/5/2022
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML	Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Sterigenics Belgium (Fleurus) (Sterilization)	SIN16543P	INJECTION, SUSPENSION	200 mg/ml	7/5/2022
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML	Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Sterigenics Belgium (Fleurus) (Sterilization)	SIN16542P	INJECTION, SUSPENSION	200mg/ml	7/5/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400MG/2ML	N/A	葛兰素史克	N/A	N/A	12/15/2021
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600MG/3ML	N/A	葛兰素史克	N/A	N/A	12/15/2021

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
VOCABRIA cabotegravir (as sodium) 30 mg film-coated tablet, bottle	323721	ViiV Healthcare Pty Ltd	Medicine	A	2/16/2021
CABENUVA cabotegravir 400 mg/2 mL plus rilpivirine 600 mg/2 mL prolonged-release suspensions for injection vials	323784	ViiV Healthcare Pty Ltd	Medicine	A	2/23/2021
APRETUDE cabotegravir 600 mg/3 mL prolonged-release suspension for injection vial	377474	ViiV Healthcare Pty Ltd	Medicine	A	8/11/2022
CABENUVA cabotegravir 600 mg/3 mL plus rilpivirine 900 mg/3 mL prolonged-release suspensions for injection vials	323783	ViiV Healthcare Pty Ltd	Medicine	A	2/23/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CABENUVA	viiv healthcare ulc	02497247	Suspension (Extended-Release) , Kit - Intramuscular	200 MG / ML	9/21/2020
APRETUDE	viiv healthcare ulc	02547473	Suspension (Extended-Release) - Intramuscular	200 MG / ML	6/19/2024
CABENUVA	viiv healthcare ulc	02497220	Kit , Suspension (Extended-Release) - Intramuscular	200 MG / ML	9/21/2020

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

ViiV Healthcare Expands Generic License for Long-Acting HIV Treatment to 133 Countries

9 days ago

ViiV Healthcare has expanded its voluntary licensing agreement with the Medicines Patent Pool to allow generic production of cabotegravir for HIV treatment in 133 countries, including all low-income and Sub-Saharan African nations.

ViiV Healthcare Presents Real-World Data on Long-Acting HIV Treatments at IAS 2025

15 days ago

ViiV Healthcare presented extensive real-world data at IAS 2025 demonstrating the effectiveness, safety, and tolerability of its long-acting injectable HIV treatments, including cabotegravir + rilpivirine LA for treatment and cabotegravir LA for prevention.

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