Virologically Suppressed HIV-1 Infection
MRKMerck & CoCatalyst overview
Research summary
This catalyst tracks a Approved update for Doravirine / Islatravir (DOR/ISL) in Virologically Suppressed HIV-1 Infection. The expected timing is based on the latest available company guidance and may change.
12/19/24- Reported topline results. 3/12/25- Data reported. Submit MA to regulatory agencies by mid-2025. 7/10/25- NDA accepted with PDUFA date April 28, 2026. 11/19/25– Topline data reported. 02/26/26:- Ph3 MK-8591A-051/052/053 showed non-inferior efficacy, durable 96-week suppression, and similar safety; PDUFA unchanged. 04/21/26:- Trials 051/052 Week 48 noninferior; FDA approved IDVYNSO; available after May 11. 07/15/26:- Week 96 DOR/ISL maintained suppression; data presented at AIDS 2026 July 28, 2026.
Verification
Confirm timing and program details against the company announcement or filing.