Treats multidrug resistant HIV-1. NDA 215974, held by Gilead Sciences Inc. Lenacapavir Sodium.
As of Nov 13, 2026, NDA 215974 (Sunlenca), held by Gilead Sciences Inc, was first approved by FDA on Dec 22, 2022, with 5 approved supplements and 1 published complete response letter.
SUNLENCA, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, is indicated: in combination with other antiretroviral(s), for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 whose current antiretroviral regimen is failing due to resistance, intolerance, or safety considerations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2026 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Nov 25, 2024 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2022 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Feb 28, 2022 | LenacapavirProduct Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| SunlencaEQ 300MG BASE · tablet;oral | Lenacapavir Sodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2026 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Mar 12, 2026 | Supplement 14Labeling · Standard review | Approved | |
| Nov 25, 2024 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Nov 13, 2024 | Supplement 9Labeling · Standard review | Approved | |
| Jul 17, 2024 | Supplement 7Labeling · Standard review | Approved | |
| Dec 22, 2022 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
