NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASEPriority Review
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CABENUVA is a two-drug intramuscular injectable suspension combining cabotegravir (an integrase strand transfer inhibitor) and rilpivirine (a non-nucleoside reverse transcriptase inhibitor) for HIV-1 treatment. Administered as a long-acting injection every 4 weeks, it offers patients an alternative to daily oral antiretroviral therapy by maintaining viral suppression through extended-release formulation technology.
Peak12.2 years to LOE
Peak-stage product with strong patent protection through 2038 suggests stable commercial operations and established brand team rather than aggressive growth hiring.
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 (5)
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
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
Started Jan 2024
90 enrolled
HIV-1-infection
Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants
Started Sep 2020
15 enrolled
HIV Infections
More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
Started Apr 2019
168 enrolled
HIV Infections
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
Started Oct 2016
631 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.