FDA approval of Rezdiffra: first NASH drug
The FDA approved Madrigal’s Rezdiffra (resmetirom) for NASH/MASH on Mar 14, 2024. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Madrigal Pharmaceuticals, Inc. MDGL
- Drug
- Rezdiffra (resmetirom)
- For
- NASH/MASH
- When
- Mar 14, 2024
- Checked
- Checked by a person when it was added
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- MDGL headlines on this site
Ervogastat/resmetirom drug-drug interaction study start, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Madrigal (Rezdiffra (resmetirom) + ervogastat for MASH combination): a step in the program rather than a decision or a data readout.
More details
- Entry
- Ervogastat/resmetirom drug-drug interaction study start · Company milestone
- Drug
- Rezdiffra (resmetirom) + ervogastat
- For
- MASH combination
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- From Madrigal's Q1 2026 results release (May 6, 2026). Madrigal's Q2 2026 release (Jul 30, 2026) gave no new dated milestones; MAESTRO-NASH OUTCOMES F4c readout remains 2027 (already listed).
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- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MDGL headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Madrigal expects to report results from its Phase 3 study of Rezdiffra (resmetirom) for Compensated MASH cirrhosis (F4c) during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- MAESTRO-NASH OUTCOMES Phase 3 topline: Rezdiffra in compensated MASH cirrhosis (F4c) · Clinical trial results (readout / topline data)
- Drug
- Rezdiffra (resmetirom)
- For
- Compensated MASH cirrhosis (F4c)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Q2 2026 press release (July 30, 2026): company expects the event-driven MAESTRO-NASH OUTCOMES study to read out in 2027, with events accruing in line with that timeframe. Success would add an F4c indication and support full approval in noncirrhotic MASH. Year-level precision only.
- Checked
- Checked by a person when it was added
- Verify it
- Source: globenewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MDGL headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page