CONSHOHOCKEN, PA — Madrigal Pharmaceuticals (NASDAQ: MDGL) announced Monday it has secured exclusive global rights to develop and commercialize SYH2086, a preclinical oral GLP-1 receptor agonist, through a licensing deal with China-based CSPC Pharmaceutical Group. The move bolsters Madrigal’s strategy to build out a next-generation pipeline for MASH, anchored by its lead drug Rezdiffra™.
The agreement includes a $120 million upfront payment and could total over $2 billion if development, regulatory, and commercial milestones are met. Royalties on net sales are also part of the deal. Madrigal expects to initiate clinical development of SYH2086 in the first half of 2026, pending regulatory clearance.
SYH2086 is an oral small molecule GLP-1 receptor agonist and a derivative of orforglipron. Early data show it delivers glucose-lowering and weight-loss effects in animal models with a favorable safety profile and consistent pharmacokinetics across species. The drug class is widely used in diabetes and obesity treatments and is known for reducing appetite, enhancing insulin secretion, and controlling blood sugar levels.
Madrigal’s goal is to combine SYH2086 with Rezdiffra in a once-daily oral therapy that could become a best-in-class treatment for metabolic dysfunction-associated steatohepatitis (MASH). Rezdiffra, which targets liver fibrosis and lipid metabolism, is already approved and on the market.
“This agreement aligns perfectly with our long-term goal to extend our leadership in MASH by building a pipeline anchored by Rezdiffra,” said Madrigal CEO Bill Sibold. “We believe a combination of Rezdiffra and SYH2086 has the potential to deliver a best-in-class oral treatment for patients with MASH.”
Chief Medical Officer David Soergel added that even modest weight loss in MASH patients improves Rezdiffra’s antifibrotic benefits. The combination approach could deliver stronger efficacy and tolerability than either drug alone.
CSPC retains rights to develop other oral GLP-1 therapies in China under certain conditions. “We believe Madrigal’s strong clinical development and commercial capabilities will help unlock the full potential of SYH2086,” said Dongchen Cai, chairman of CSPC.
A Growing Market for MASH Treatment
MASH, previously known as NASH, is a progressive liver disease and a leading cause of liver transplantation, particularly among women. Patients with moderate to advanced fibrosis (F2-F3) are at significantly increased risk of liver failure and cardiovascular disease, the latter being the top cause of death among this population.
As awareness and diagnostic rates improve, the number of patients with advanced MASH or early cirrhosis (F2-F4c) is expected to climb sharply in the coming years. Madrigal is positioning itself to meet this growing demand by expanding its pipeline with novel combination therapies.
The SYH2086 licensing deal is expected to close in the fourth quarter of 2025, subject to regulatory approvals.
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