Madrigal Pharmaceuticals Expands MASH Pipeline with Exclusive Licensing Agreement for Ervogastat
CONSHOHOCKEN, Pa., Jan. 09, 2026 (GLOBE NEWSWIRE) – Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a leading biopharmaceutical company specializing in therapies for metabolic dysfunction-associated steatohepatitis (MASH), has announced a significant milestone in its development pipeline. The company has entered into an exclusive global license agreement with Pfizer for ervogastat, a promising clinical-stage oral DGAT-2 inhibitor. This move is poised to enhance Madrigal's leadership in MASH therapies and provide new avenues for combination treatment strategies.
Understanding Ervogastat and Its Role in MASH Treatment
Ervogastat (PF-06865571) is designed to inhibit the enzyme diacylglycerol O-acyltransferase 2 (DGAT-2), blocking the final step in triglyceride assembly and storage. This mechanism is crucial as it leads to lower hepatic triglycerides, reduces lipotoxic fat, and decreases inflammation in the liver. The integration of ervogastat with existing treatments, like Rezdiffra® (resmetirom), offers potential for additive therapeutic benefits tailored to MASH.
- 72% of patients treated with ervogastat achieved at least a 30% reduction in liver fat.
- 61% of patients observed a reduction of at least 50% in liver fat, measured using MRI-PDFF.
- This treatment is expected to enable improved liver function and potentially better patient outcomes.
Madrigal's Strategic Focus on Combination Therapies
Bill Sibold, Chief Executive Officer of Madrigal, expressed enthusiasm about the agreement, stating, “Madrigal is committed to building the industry-leading pipeline that will shape the future of MASH care and improve patient outcomes.” He emphasized that the licensing of ervogastat aligns with the company's long-term ambitions and positions Madrigal to capitalize on this Phase 2 asset.
Madrigal’s approach is to use Rezdiffra as foundational therapy. Combined with ervogastat, these therapies could provide a robust treatment strategy. Professor Quentin Anstee, a leading investigator, noted that there's a compelling scientific rationale for this combination, suggesting potential for enhanced efficacy based on distinct yet complementary mechanisms driving liver fat accumulation.
The Implications of the License Agreement
Under the terms of this agreement, Pfizer will grant Madrigal the exclusive rights to develop, manufacture, and commercialize ervogastat, in addition to rights to two other early-stage MASH assets. The deal includes an upfront payment of $50 million USD, which will be reflected in Madrigal’s Q4 2025 financials, alongside potential milestone payments and royalties on sales.
Anticipated studies in 2026 include a drug-to-drug interaction study with Rezdiffra and consultations with the FDA to design a Phase 2 combination trial, further signaling the strategic path forward for Madrigal in the fiercely competitive biopharmaceutical landscape focused on MASH treatments.
About MASH and Its Growing Importance
Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to fibrosis, cirrhosis, and liver failure. With increasing prevalence, MASH poses significant health risks, especially among populations with moderate to advanced liver fibrosis. As awareness and diagnosis rates improve, the number of patients requiring effective treatments is expected to rise significantly.
MASH is now recognized as a leading cause of liver transplantation, making advancements like those from Madrigal critical for addressing patient needs within this growing demographic.