Rezdiffra

by Madrigal PharmaceuticalsUS

Establish Rezdiffra as the standard first-line MASH therapy by confirming long-term outcomes and expanding global approvals and market access.

DeployStage 4 of 5

First FDA-approved MASH therapy (March 2024); Q2 2026 sales $364M (+71%); global expansion ongoing.

Updated Q2 2026Checked 11 Oct0 updates this week

Milestones

Next · Country-by-country European rollout ongoing
  1. Phase 3 MAESTRO-NASH trial initiated2019Complete.
  2. MAESTRO-NASH Phase 3 52-week data meets primary endpoint2023Complete.
  3. FDA grants accelerated approval to RezdiffraMar 2024Complete.
  4. Commercial launch in United StatesApr 2024Complete.
  5. EMA grants conditional marketing authorizationAug 2025Complete.
  6. Launch in Germany (first European market)Sep 2025Complete.
  7. Country-by-country European rollout ongoingTarget 2026Current milestone.
  8. MAESTRO-NASH Outcomes trial (54-month confirmatory data) expectedTarget 2028Not yet reached.

Most important updates

Upcoming

  1. 2026Country-by-country European rollout ongoing (next)
  2. 2027Full FDA approval (conversion from accelerated approval)
  3. 2028MAESTRO-NASH Outcomes trial (54-month confirmatory data) expected
Primer