MGL-3196

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

MADRIGAL PHARMACEUTICALS, INC. MDGL · NASH - Nonalcoholic Steatohepatitis

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indication
NASH - Nonalcoholic Steatohepatitis Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 28 Mar 20191 linked trial
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for MGL-3196. Editors add each one with its source.

Filed application

No filed application is on record for MGL-3196. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for MGL-3196.

Clinical trials

Trials linked to MGL-3196
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT03900429ClinicalTrials.gov record for NCT03900429 (opens in a new tab)MAESTRO-NASHA Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and FibrosisPhase 3Active, not recruiting1,759 (actual)Jan 2028 (estimated) No

Publications listing MAESTRO-NASH (7), newest first

  1. Effects of MASH risk genotypes on resmetirom efficacy in patients with MASH and fibrosis.

    Journal of hepatology · 2026 Oct 5

  2. Quantitative regression of qFibrosis with resmetirom: Exploratory histologic endpoints from the MAESTRO-NASH phase III clinical trial.

    Journal of hepatology · 2026 Aug

  3. Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH Trial.

    Alimentary pharmacology & therapeutics · 2025 Dec

  4. Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.

    Hepatology (Baltimore, Md.) · 2025 Apr 1

  5. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis.

    The New England journal of medicine · 2024 Feb 8

All 7 publications for NCT03900429

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as MGL-3196.

Source: European Medicines Agency (EMA), medicines data download.

Related news

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Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.