NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASEPriority Review
Approved
Dec 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
HIV-1 antiretroviral drug [see Microbiology ()] in a long-acting formulation.
Clinical Trials (5)
A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1
Started Mar 2026
66 enrolled
HIV Infections
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
Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs
Started Nov 2025
100 enrolled
HIVSubstance Use Disorder (SUD)Injection Drug Use
Switch From Oral Therapy to Long-acting Injectable Cabotegravir + Rilpivirine
Started May 2025
50 enrolled
Patient SatisfactionPatient PreferenceQuality of Life+1 more
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
Started Apr 2025
65 enrolled
HIV Infections
Loss of Exclusivity
LOE Date
Sep 15, 2031
67 months away
Patent Expiry
Sep 15, 2031
Exclusivity Expiry
Jan 21, 2026