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Sunlenca FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 17, 2023.

FDA Approved: Yes (First approved December 22, 2022)
Brand name: Sunlenca
Generic name: lenacapavir
Dosage form: Injection and Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Sunlenca (lenacapavir) is a long-acting HIV-1 capsid inhibitor for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

Development timeline for Sunlenca

DateArticle
Dec 22, 2022Approval FDA Approves Sunlenca (lenacapavir) Twice-Yearly Treatment for People Living With Multi-Drug Resistant HIV
Jun 27, 2022Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor
May 16, 2022FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV
Mar  1, 2022Gilead Receives Complete Response Letter From U.S. FDA for Investigational Lenacapavir Due to Vial Compatibility Issues
Feb 16, 2022New Clinical Data Support the Sustained Efficacy of Long-acting Lenacapavir, Gilead’s Investigational HIV-1 Capsid Inhibitor
Dec 21, 2021Gilead Announces Clinical Hold on Studies Evaluating Injectable Lenacapavir for HIV Treatment and Prevention Due to Vial Quality Concerns
Oct 26, 2021Gilead and Merck Initiate Phase 2 Study Evaluating an Oral Weekly Combination Regimen of Investigational Lenacapavir and Investigational Islatravir for HIV-1 Treatment in Virologically Suppressed Adults
Jul 17, 2021New Phase 3 Data Support the Sustained, Long-Acting Efficacy of Lenacapavir, Gilead's Investigational HIV-1 Capsid Inhibitor
Jun 28, 2021Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options
Mar 15, 2021Gilead and Merck Announce Agreement to Jointly Develop and Commercialize Long-Acting, Investigational Treatment Combinations of Lenacapavir and Islatravir in HIV
Mar  9, 2021Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI
Nov 18, 2020Gilead Announces Investigational Long-Acting HIV-1 Capsid Inhibitor, Lenacapavir, Achieves Primary Endpoint in Phase 2/3 Study in Heavily Treatment-Experienced People Living With HIV
Jul  4, 2020Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207)

See also

Sunlenca (lenacapavir) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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