Resmetirom (Rezdiffra): MASH Treatment Landscape and Rivals

Resmetirom, sold by Madrigal Pharmaceuticals as Rezdiffra, was the first drug approved in the United States for MASH, metabolic dysfunction-associated steatohepatitis (the term now used for what was called NASH). It is a fatty liver disease with inflammation and scarring. As of November 4, 2026, Wegovy has since won a MASH approval, and several other drugs are in Phase 3.

Mechanism at a glance

The European Medicines Agency describes resmetirom as a thyroid hormone receptor beta (THR-beta) agonist that acts in liver cells to increase fat breakdown and reduce liver fat. It is a tablet taken once a day. The FDA granted accelerated approval on March 14, 2024 for adults with noncirrhotic MASH and moderate to advanced fibrosis (stages F2 to F3), alongside diet and exercise. Madrigal lists diarrhea, nausea, itching, abdominal pain, vomiting, dizziness and constipation as common adverse reactions; diarrhea and nausea typically began early and were mild to moderate.

Why it matters

The approval rested on the Phase 3 MAESTRO-NASH trial (1,759 patients), in which Madrigal reported that both the 80 mg and 100 mg doses significantly beat placebo at week 52 on both primary endpoints: MASH resolution without worsening of fibrosis, and fibrosis improvement of at least one stage without worsening of the activity score. Because the approval is accelerated, MAESTRO-NASH continues as an outcomes study to confirm clinical benefit. In Europe, the European Commission granted conditional authorization on August 18, 2025, and Madrigal launched in Germany in September 2025.

Competitive pressure points

• Wegovy (semaglutide): the FDA granted accelerated approval for noncirrhotic MASH with moderate to advanced fibrosis in August 2025. In the first 800 patients at week 72, 63% on Wegovy achieved MASH resolution without fibrosis worsening vs 34% on placebo. Novo says Wegovy is also approved for MASH (F2 to F3) in the UK and Japan, and the FDA has accepted a MASH filing for the Wegovy pill with a decision expected in Q1 2027. See our semaglutide landscape.
• Survodutide: Boehringer Ingelheim’s GLP-1/glucagon agonist is in two Phase 3 MASH trials on ClinicalTrials.gov: LIVERAGE (F2 to F3, 1,800 planned, estimated primary completion December 2031) and LIVERAGE-Cirrhosis (1,590, June 2029). See the survodutide landscape.
• FGF21 analogs: efruxifermin is in Phase 3 trials registered by Akero, which Novo Nordisk reportedly acquired in December 2025; Novo’s May 2026 release says it is not approved in the US. The registry lists Roche as sponsor of two Phase 3 pegozafermin trials (ENLIGHTEN-Fibrosis, 1,350 planned; ENLIGHTEN-Cirrhosis, 1,800 planned).
• Lanifibranor: Inventiva’s Phase 3 NATiV3 trial has completed its last patient visit (announced September 2026), with topline results expected in Q4 2026 according to news summaries of the company’s announcement.

What to watch

1. Rezdiffra’s trajectory against Wegovy in the F2 to F3 population, and whether the two are used together or in sequence.
2. MAESTRO-NASH OUTCOMES in compensated cirrhosis (F4c): Madrigal says data are expected in late 2027, while the registry still estimates primary completion in December 2026.
3. NATiV3 topline data for lanifibranor.
4. Madrigal’s planned MAESTRO-CSPH outcomes trial, which would enroll more than 2,000 F4c patients with clinically significant portal hypertension.

Recent developments

Updated November 4, 2026. Items are drawn from company announcements, regulators and trade press; links go to the sources.

• Nov 3, 2026: Madrigal reported Q3 Rezdiffra net sales of $431.3 million, up 50% from $287.3 million a year earlier, with more than 55,850 patients on therapy and $961.8 million in cash and securities. Nine-month net sales were $1,106.9 million. (Madrigal Q3 release, 10-Q)
• Nov 3, 2026: Madrigal said MAESTRO-NASH OUTCOMES is “on track, data expected late 2027,” and that it expects to start MAESTRO-CSPH in the first half of 2027, subject to regulatory discussions. (Madrigal Q3 release)
• Oct 27, 2026: Madrigal announced it would present data at The Liver Meeting, including real-world analyses covering more than 12,000 patients, and said Rezdiffra would feature in more abstracts than any other MASH therapy. (BiopharmaWatch summary)
• Aug 4, 2026: Novo reported Wegovy MASH approvals in Japan and the UK and the FDA’s acceptance of the Wegovy pill MASH filing. (Novo Nordisk 6-K)
• Aug 15, 2025: FDA approved Wegovy for noncirrhotic MASH (reported Aug 18). (MedCity News)
• Aug 18, 2025: European conditional marketing authorization for Rezdiffra. (EMA)
• Mar 14, 2024: FDA accelerated approval of Rezdiffra. (Madrigal release via TipRanks)

Upcoming catalysts

• Nov 5-9, 2026: AASLD The Liver Meeting, Colorado Convention Center, Denver. Madrigal has said it will present Rezdiffra data there; we did not find announced results from competitors.
• Q4 2026: Inventiva’s expected NATiV3 topline readout.
• Q1 2027: expected FDA decision on the Wegovy pill for MASH (Novo).
• First half of 2027: planned start of MAESTRO-CSPH (Madrigal).
• Late 2027: MAESTRO-NASH OUTCOMES data (Madrigal).

Bottom line

Rezdiffra has grown quickly, but its position now depends on cirrhosis outcomes data in 2027 and on how Wegovy, FGF21 drugs and lanifibranor reshape the market. Competitors’ data in the near term come mainly from trials that are still running.

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This article is for informational and competitive-intelligence purposes only and is not medical advice. Approvals, labels and trial results change; verify details against current prescribing information and primary sources.