drug
resmetirom
Marketedupdated 3mo agoby $MDGL MADRIGAL PHARMACEUTICALS, INC.
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for non-alcoholic fatty liver disease and cirrhosis of liver and 5 investigational indications.
all catalysts(4)
approval · 4
Mar 14, 2024
approval
$MDGL540.16+3.01%
REZDIFFRA (RESMETIROM) — FDA approval
resmetirom
→
Dec 19, 2025
approval
$MDGL540.16+3.01%
REZDIFFRA (RESMETIROM) — FDA approval
resmetirom
→
Dec 19, 2025
approval
$MDGL540.16+3.01%
REZDIFFRA (RESMETIROM) — FDA approval
resmetirom
→
Dec 19, 2025
approval
$MDGL540.16+3.01%
REZDIFFRA (RESMETIROM) — FDA approval
resmetirom
→
Trials studying resmetirom
- phase2Study of Resmetirom in Children and Adolescents With MASH
- phase3A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
- phase2Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
- —Rezdiffra Pregnancy and Lactation Registry
- phase1A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants
- phase2Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
- phase4Resmiterom Efficacy & Safety in Patients With MASH
- phase1A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses (6 Days) of 100 mg Resmetirom in Subjects With Severe Renal Impairment and in Matched Healthy Control Subjects With Normal Renal Function
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 12, 2026
23 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (18)
- Feb 4, 2045method-of-use (U-3861)US 12377104
- Feb 4, 2045method-of-use (U-3861)US 12377104
- Feb 4, 2045method-of-use (U-3861)US 12377104
- Sep 17, 2033method-of-use (U-3861)US 10376517
- Sep 17, 2033method-of-use (U-3861)US 10376517
- Sep 17, 2033method-of-use (U-3861)US 10376517
- Sep 17, 2033compositionUS 11564926
- Sep 17, 2033compositionUS 11564926
- Sep 17, 2033compositionUS 11564926
- Sep 17, 2033method-of-use (U-3861)US 11986481
- Sep 17, 2033method-of-use (U-3861)US 11986481
- Sep 17, 2033method-of-use (U-3861)US 11986481
- Sep 17, 2033compositionUS 9266861
- Sep 17, 2033compositionUS 9266861
- Sep 17, 2033compositionUS 9266861
- Sep 12, 2026compositionUS 745288223d
- Sep 12, 2026compositionUS 745288223d
- Sep 12, 2026compositionUS 745288223d
FDA exclusivities (3)
- Mar 14, 2029NCENew Chemical Entity (5y)2.6y
- Mar 14, 2029NCENew Chemical Entity (5y)2.6y
- Mar 14, 2029NCENew Chemical Entity (5y)2.6y
News(5)
- ‘It’s making a difference’: Madrigal CEO talks strategy behind MASH shopping spreeNot content with navigating Rezdiffra’s trajectory to blockbuster territory, Madrigal Pharmaceuticals has spent 2026 shopping for a range of drugs that the company hopes could work alongside its me…fiercebiotech · 19d ago
- Rezdiffra is exceeding Wall Street's expectations as the MASH market takes shapeIt seems there’s room for two in the MASH market. When Novo Nordisk’s blockbuster weight loss drug Wegovy won approval in August 2025 to treat the fatty liver disease, some investors thought it wou…endpoints · 3mo ago
- Madrigal's Rezdiffra beats estimates; Gilead cuts jobs; Banyan debuts🚀 Madrigal Pharmaceuticals' MASH drug beats expectations: The biotech’s Rezdiffra sales came in at $311 million for the first quarter, surpassing analysts’ projections by about $10 million, accord…endpoints · 3mo ago
- STAT+: Novo Nordisk’s less-bad news on its Wegovy pill boosts earnings and share priceVivek Ramaswamy wins GOP primary for Ohio governor, CellCentric raises $220M for myeloma drug, and more biotech newsstat · 3mo ago
- Biotech investors gamble on M&A. Some drugmakers are betting on themselves instead.Young biotechs usually get acquired instead of profitably selling their own medicines. A growing number are proving they can, which could make the sector more broadly appealing to investors, some say.biopharma_dive · 3mo ago
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