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 5h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APRETUDE (cabotegravir) is a long-acting integrase strand transfer inhibitor (INSTI) administered as an intramuscular injection for HIV prevention and treatment. It is a small-molecule antiretroviral that provides extended-release protection, reducing dosing frequency compared to oral alternatives. The drug represents a significant advancement in HIV care by enabling quarterly or biannual dosing through depot formulation technology.
$0.011BPart D
Peak5.0 years to LOEAPRETUDE is at peak lifecycle stage with limited Part D claims, indicating early market penetration; brand and commercial teams are focused on market expansion and provider education during growth phase.
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)
A Phase 2b Study Evaluating VH4011499 Capsid Inhibitor Long-Acting Injectable Plus Cabotegravir in Treatment Naïve Adults (CINERGY)
Started Oct 2026
200 enrolled
HIV Infections
Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
Started Oct 2026
40 enrolled
HIV -1 Infection
Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
Started Jul 2026
590 enrolled
HIV Infections
Cabotegravir-Hormone PK/PD Interactions for HIV Prevention
Started Jul 2026
32 enrolled
HIVProphylaxisInjectable
A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
Started Jun 2026
564 enrolled
HIV Infections
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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.