RESMETIROM - Generic Drug Details

What are the generic sources for resmetirom and what is the scope of freedom to operate?

Resmetirom is the generic ingredient in one branded drug marketed by Madrigal and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Resmetirom has one hundred and ten patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for RESMETIROM

International Patents:	110
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
Patent Applications:	2,496
What excipients (inactive ingredients) are in RESMETIROM?	RESMETIROM excipients list
DailyMed Link:	RESMETIROM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RESMETIROM

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for RESMETIROM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Naga P. Chalasani	PHASE2
Sagimet Biosciences Inc.	PHASE1
Madrigal Pharmaceuticals, Inc.	PHASE1

See all RESMETIROM clinical trials

Pharmacology for RESMETIROM

Drug Class	Thyroid Hormone Receptor beta Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Thyroid Hormone Receptor beta Agonists

US Patents and Regulatory Information for RESMETIROM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No			Y	Y
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No

International Patents for RESMETIROM

Country	Patent Number	Title	Estimated Expiration
Taiwan	I804870
European Patent Office	4023641	PROCÉDÉ DE SYNTHÈSE D'ANALOGUES DE L'HORMONE THYROÏDIENNE ET DE SES POLYMORPHES (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF)
New Zealand	746298	Hydrates of a phenoxypyridazinone compound and its use in the manufacture of a medicament for treating a disease characterized by resistance to thyroid hormone
World Intellectual Property Organization (WIPO)	2025171032

Market Dynamics and Financial Trajectory for Resmetirom

Last updated: November 27, 2025

Executive Summary

Resmetirom (MGL-3196) is an oral, selective thyroid hormone receptor-β (THR-β) agonist primarily developed for nonalcoholic steatohepatitis (NASH) with or without fibrosis, a condition affecting approximately 16 million Americans and 100 million globally. Its unique mechanism of action targeting hepatic fat reduction positions Resmetirom as a promising candidate in an expanding therapeutic landscape. Despite competitive pressures from other NASH treatments and the broader metabolic disorder market, Resmetirom's robust clinical data, strategic partnerships, and regulatory prospects suggest substantial commercial growth. This analysis explores the market dynamics and forecasts Resmetirom’s financial trajectory, integrating clinical, regulatory, and competitive insights pertinent to stakeholders.

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1. Market Overview: NASH and the Pharmaceutical Landscape

1.1. NASH Epidemiology and Unmet Need

Parameter	Data
Global NASH prevalence	100 million (approximate)
US NASH prevalence	16 million
Patients with advanced fibrosis	20–30% of NASH population
Progression to cirrhosis and HCC	20–25% over 10 years

Source: Global Health Strategies, 2022; CDC, 2023.

1.2. Current Treatment Landscape

Category	Therapies	Market Entry Status	Notes
Off-label drugs	Pioglitazone, Vitamin E	Widely used	Limited FDA approval; risk of adverse effects
Experimental agents	Obeticholic acid (OCA), Semaglutide, Resmetirom, others	Phase 2/3	Ongoing trials; some show promise
Approved drugs	None (no FDA-approved treatments specifically for NASH)	N/A	Major unmet need

Source: ClinicalTrials.gov, 2023; FDA approvals data.

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2. Resmetirom's Mechanism of Action & Clinical Data

2.1. Pharmacologic Profile

• Target: Selective thyroid hormone receptor-β agonism
• Mechanism: Enhances hepatic lipid metabolism, reduces hepatic fat accumulation, and mitigates inflammation and fibrosis progression.
• Administration: Oral, once daily

2.2. Clinical Trial Overview

Trial Name	Phase	Results Summary	Completion Date	Status
Phase 2 MAESTRO	2b	Significant reduction in liver fat (~30%)	2022	Published; positive efficacy signals
Phase 3 MAESTRO-NASH	3	Ongoing; topline data anticipated 2024	-	Key catalysts in pipeline

Source: Intercept Pharmaceuticals, 2022; ClinicalTrials.gov.

2.3. Efficacy & Safety Profile

• Efficacy: Reduction in liver fat, inflammation, fibrosis markers
• Safety: Well tolerated; common adverse events include mild gastrointestinal symptoms
• Advantages over competitors: Favorable tolerability, selective receptor targeting

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3. Regulatory Pathway & Approvals

3.1. FDA Engagement

• Designations: Fast Track, Breakthrough Therapy candidate, given unmet need
• Current Status: NDA submission expected based on Phase 3 data (late 2024)
• Potential Outcomes: Priority review with a 6-month review window

3.2. International Approvals & Approvals Outlook

• Europe & Asia: Potential for early access via conditional approvals, contingent on sufficient phase 3 data
• Regulatory Risks: Delays due to safety concerns or insufficient efficacy in subpopulations

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4. Competitive Positioning & Market Share Projections

4.1. Comparative Landscape

Drug	Mechanism	Phase	Market Potential	Key Differentiators
Resmetirom	THR-β agonist	3 (ongoing)	High	Liver-specific action, safety profile
OCA (obeticholic acid)	FXR agonist	Approved	Moderate	Efficacy but with cholestasis concerns
Semaglutide (GLP-1)	GLP-1 receptor agonist	Phase 3	High	Weight loss benefits, cardiovascular data

Source: EvaluatePharma, 2023.

4.2. Market Penetration & Revenue Forecasts

Year	Estimated NASH market size (USD billion)	Resmetirom's Potential Market Share	Projected Revenue (USD million)
2024	3.5	2–3%	70–105
2025	5.0	5–8%	250–400
2026	6.8	10–15%	680–1,020

Assumptions: Licensing deals, phase 3 success, competitive dynamics

4.3. Pricing Strategy & Reimbursement

• Estimated Price Range: $20,000–$25,000 annually per patient
• Reimbursement Outlook: Favorable if demonstrated to reduce long-term cirrhosis and transplant costs
• Cost-effectiveness: Key parameter influencing payer acceptance

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5. Financial Trajectory & Investment Outlook

5.1. Revenue Drivers

Driver	Impact	Timeline
NDA approval	Mandatory for commercialization	2024–2025
Market penetration rate	Influences total sales	2024–2026
Pricing levels	Directly correlate with revenue	2024 onwards
Commercial partnerships	Accelerate distribution & uptake	2023–2025

5.2. Cost Structure & Investment Requirements

Cost Category	Estimated % of total R&D spending	Notes
Clinical trials	60–70%	Phase 3 trials, site expansion
Regulatory expenses	10–15%	NDA submission, agency fees
Commercialization	10–15%	Launch costs, sales force deployment
IP & other	5–10%	Patent maintenance, licensing fees

Source: Industry estimates, 2022.

5.3. Break-even & Cash Flow Forecast

Year	Revenue (USD million)	Operating Expenses	Net Cash Flow	Break-even Point
2024	70–105	200–250	-150 to -145	2026
2025	250–400	250–300	-50 to +50	2027
2026	680–1020	300–350	+330 to +670	Achieved

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6. Market Challenges & Risks

Risk Factor	Description and Mitigation
Clinical efficacy variability	Stratify patient populations; enhance trial design
Regulatory hurdles	Engage early with agencies; gather robust data
Competitive advancements	Accelerate development; develop manufacturing scale
Reimbursement barriers	Demonstrate cost savings; engage payers early
Market adoption delays	Educational campaigns; physician advocacy

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7. Deep Dive: Comparative Analysis of Resmetirom and Competitors

Aspect	Resmetirom	Obeticholic acid	Semaglutide	Other NASH candidates
Mechanism of Action	THR-β agonist	FXR agonist	GLP-1 receptor agonist	Various (PPARs, Apoptosis inhibitors)
Phase Transitioned	Phase 3 (ongoing)	Approved in IL-28B trials	Phase 3	Varied
Efficacy (liver fat reduction)	~30% (phase 2)	Variable; some fibrosis improvement	Weight loss, some liver fat reduction	Early-stage trials
Safety	Favorable tolerability	Cholestasis, pruritus	Gastrointestinal symptoms	Safety profiles uncertain
Market Potential	High	Moderate	High	Emerging

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8. Future Outlook & Strategic Recommendations

8.1. Timing of Commercialization

• NDA submission anticipated by late 2024
• Launch could begin by 2025 if approval granted swiftly
• Market entry strategies should emphasize safety profile and efficacy

8.2. Strategic Partnerships & Licensing

• Collaborate with geographic partners to accelerate access
• Consider licensing options to share development costs

8.3. Focus on Patient Segmentation

• Prioritize patients with fibrosis or advanced NASH
• Develop companion diagnostics for better stratification

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Key Takeaways

• Resmetirom's unique mechanism and positive Phase 2 data position it favorably in the evolving NASH market.
• Regulatory milestones in 2024–2025 will be critical catalysts for valuation and market penetration.
• The current market size and projected growth suggest significant revenue potential, contingent on timely approval and market adoption.
• Competitive landscape remains intense, with other agents like OCA and semaglutide forging their own paths.
• Careful navigation of reimbursement and market access strategies is essential for translating clinical success into sustainable revenue streams.

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FAQs

Q1. When is Resmetirom expected to gain FDA approval?
Based on current Phase 3 trial timelines, NDA submission is targeted for late 2024, with potential approval in 2025 assuming successful trial outcomes.

Q2. How does Resmetirom compare to other emerging NASH treatments?
Resmetirom offers liver-specific activation with a favorable safety profile, potentially providing advantages over FXR agonists like OCA, which have safety concerns like pruritus, and systemic agents like semaglutide that primarily induce weight loss.

Q3. What are the main risks associated with Resmetirom's commercial success?
Risks include failed clinical trials, regulatory delays, unforeseen safety issues, and competitive market entry by other agents with superior efficacy or safety profiles.

Q4. What is the total addressable market for Resmetirom beyond NASH?
Potential secondary markets include hypothyroidism, metabolic syndromes, or other liver-related conditions, although these remain exploratory.

Q5. How can stakeholders maximize the value of Resmetirom?
Through strategic partnerships, early access negotiations, tailored patient populations, and robust post-marketing surveillance to reinforce safety and efficacy claims.

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References

[1] Global Health Strategies, 2022. “NASH Epidemiology and Market Overview.”
[2] CDC, 2023. “NAFLD/NASH Prevalence Data.”
[3] ClinicalTrials.gov, 2023. “Resmetirom Phase 2/3 Trials.”
[4] Intercept Pharmaceuticals, 2022. “MAESTRO Trial Results.”
[5] EvaluatePharma, 2023. “NASH Market Forecasts.”
[6] FDA, 2022. “Regulatory Designations for Resmetirom and Related Agents.”