NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASEPriority Review
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Mechanism of Action
2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine [see Microbiology ()] .
Clinical Trials (4)
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
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
Loss of Exclusivity
LOE Date
Jul 18, 2038
150 months away
Patent Expiry
Jul 18, 2038
Exclusivity Expiry
Jan 21, 2026