Merck DOR/ISL started EMA evaluation on May and may receive EU approval as early as Q4 2026.

Merck’s DOR/ISL is now listed in the EMA’s June list of medicines under evaluation; signaling ongoing EU regulatory review (Product number: EMEA/H/C/006642). The list also confirms DOR/ISL is not under accelerated assessment. Based on standard EMA / CHMP review timelines, Merck may receive EU approval for DOR/ISL as early as Q4 2026.

Key Details:

• The list notes DOR/ISL started evaluation on May 21, 2026. Based on standard procedural timelines for initial marketing authorisation applications, this suggests the initial application was submitted by April 30, 2026 (EU Full MAA Timelines).

CI Assessment:

• Further updates are expected to be disclosed at the upcoming June CHMP meeting, which is scheduled for June 22-25. The June CHMP meeting agenda has not yet been released. CI anticipates both DOR/ISL 96W VS data (presented at CROI 2026) and TN data to be discussed.
• Based on standard EMA / CHMP review timelines, DOR/ISL may receive a CHMP opinion or List of Questions (LoQ) in September 2026.
  • If the CHMP opinion is positive and Merck receives no LoQ, an EMA approval would be expected ~67 days post recommendation. Therefore, earliest possible EU approval is Q4 2026 but may potentially be later if Merck receives any questions from regulators.
• EMA’s ongoing assessment for DOR/ISL extends Merck’s regulatory momentum beyond the recent US FDA approval, where Merck may look to reinforce DOR/ISL positioning as a 2-drug, non-INSTI, tenofovir-free option.