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Cabenuva FDA Approval History

FDA Approved: Yes (First approved January 21, 2021)
Brand name: Cabenuva
Generic name: cabotegravir and rilpivirine
Dosage form: Extended-Release Injectable Suspension ( Co-Packaged)
Company: ViiV Healthcare
Treatment for: HIV Infection

Cabenuva (cabotegravir and rilpivirine) is a long-acting, injectable regimen of the HIV-1 integrase strand transfer inhibitor (INSTI) cabotegravir, and the HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine indicated as a complete regimen for the treatment of HIV-1 infection in adults.

Development Timeline for Cabenuva

Jan 21, 2021Approval  FDA Approves Cabenuva (cabotegravir and rilpivirine) Long-Acting Injectable HIV Treatment and Vocabria (cabotegravir) Oral HIV Treatment
Oct 21, 2020ViiV Healthcare Announces Analysis Showing no Antiretroviral Therapy Interruptions Due to COVID-19 Across its Clinical Development Programme for Investigational, Long-Acting Cabotegravir and Rilpivirine
Mar  9, 2020Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks
Mar  9, 2020Janssen Announces 48-week Results of Phase 3b Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment of Rilpivirine and Cabotegravir Administered Every Two Months
Dec 21, 2019FDA Complete Response Letter for Investigational Cabotegravir and Rilpivirine Long-Acting HIV Treatment
Aug 22, 2019Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months
Jul  8, 2019ViiV Healthcare Announces Start of First-Ever Study to Identify and Evaluate Approaches to Implementing its Once-Monthly Injectable HIV Treatment in Clinical Practice
Apr 29, 2019Janssen Announces Submission of New Drug Application to U.S. FDA For the First Monthly, Injectable, Two-Drug Regimen of Rilpivirine and Cabotegravir for Treatment of HIV

Further information

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