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 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APRETUDE (cabotegravir) is a small-molecule integrase strand transfer inhibitor (INSTI) administered as a long-acting intramuscular injection for HIV prevention and treatment. It represents a shift toward injectable antiretroviral therapy, offering extended-release formulation that reduces dosing frequency. The drug is indicated for HIV prevention in at-risk populations and as part of combination antiretroviral therapy.
$11MPart D
Peak5.2 years to LOEProduct is in peak commercial phase with modest Part D penetration; teams are focused on market expansion and patient access optimization ahead of patent expiry.
Mechanism 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)
Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Started Jul 2026
40 enrolled
HIV -1 Infection
Long-Acting Cabotegravir and Rilpivirine in People Living With HIV-1 Subtype A6: A Real-World Retrospective Study
Started May 2026
250 enrolled
Human Immunodeficiency Virus (HIV)-1 InfectionHIV-1 Subtype A6 InfectionHIV-1 Subtype B Infection+1 more
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
Started Apr 2026
44 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
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.