NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASEPriority Review
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APRETUDE (cabotegravir) is a small-molecule integrase strand transfer inhibitor approved by the FDA on December 20, 2021, as an extended-release intramuscular suspension administered by GSK. It is indicated for HIV infection treatment, HIV prevention (PrEP), and has been studied in substance use disorder and tuberculosis contexts. The drug represents a novel long-acting injectable approach to antiretroviral therapy, offering dosing convenience compared to daily oral regimens and addressing adherence challenges in HIV management.
$0.0BPart D
5.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
Started Mar 2026
66 enrolled
HIV Infections
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Started Feb 2026
100 enrolled
HIVSubstance Use Disorder (SUD)Injection Drug Use
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
Started Feb 2026
250 enrolled
Human Immunodeficiency Virus (HIV)-1 InfectionHIV-1 Subtype A6 InfectionHIV-1 Subtype B Infection+1 more
Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Started May 2025
50 enrolled
Patient SatisfactionPatient PreferenceQuality of Life+1 more
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Started May 2025
0HIV-1-infectionPregnancyPostpartum
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.