MedPath

Cabotegravir

Generic Name
Cabotegravir
Brand Names
Apretude, Vocabria
Drug Type
Small Molecule
Chemical Formula
C19H17F2N3O5
CAS Number
1051375-10-0
Unique Ingredient Identifier
HMH0132Z1Q

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.

Background

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

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

VOCABRIA FILM-COATED TABLETS 30MG
Manufacturer:Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Glaxo Wellcome, S.A. (Primary and Secondary Packaging)
Form:TABLET, FILM COATED
Strength:30mg
Online:Yes
Approved: 2022/07/05
Approval:SIN16541P
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 400 MG/ 2 ML
Manufacturer:Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Sterigenics Belgium (Fleurus) (Sterilization)
Form:INJECTION, SUSPENSION
Strength:200 mg/ml
Online:Yes
Approved: 2022/07/05
Approval:SIN16543P
VOCABRIA PROLONGED-RELEASE SUSPENSION FOR INJECTION 600 MG/3 ML
Manufacturer:Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Sterigenics Belgium (Fleurus) (Sterilization)
Form:INJECTION, SUSPENSION
Strength:200mg/ml
Online:Yes
Approved: 2022/07/05
Approval:SIN16542P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath