HANGZHOU, China, March 14, 2026 /PRNewswire/ -- Vimgreen Pharmaceuticals, a leading innovator in adenosine signaling modulation, today announced the approval of its Investigational New Drug (IND) application for VG081821 in non‑alcoholic steatohepatitis (NASH), increasingly referred to as metabolic dysfunction‑associated steatohepatitis (MASH), by the China's Center for Drug Evaluation (CDE). This achievement represents the second clinical indication for the company's lead drug candidate, complementing its ongoing development program for Parkinson's disease.

This approval constitutes the first global clearance of an A2A receptor antagonist for NASH clinical investigation. VG081821 can proceed directly to Phase II NASH trials, significantly shortening the clinical development timeline for this potential breakthrough therapy.

NASH is a progressive liver disease characterized by excessive fat accumulation (steatosis), hepatocellular injury, inflammation, and progressive fibrosis. With obesity and metabolic syndrome reaching epidemic proportions worldwide, NASH has emerged as a leading cause of cirrhosis and hepatocellular carcinoma. Despite its increasing prevalence and severe clinical consequences, the therapeutic landscape remains highly limited: to date, only two pharmacological agents—resmetirom and semaglutide—have been granted merely accelerated approval, underscoring a critical unmet need for additional effective treatment options.

As an A2A receptor antagonist, VG081821 simultaneously targets the three core pathological features of NASH: steatosis, inflammation, and fibrosis. Given the complex pathophysiology of NASH, this multi-dimensional therapeutic approach offers distinct advantages, positioning VG081821 as a highly promising candidate for NASH therapy.

Compelling epidemiological evidence strongly supports the therapeutic potential of A2AR antagonists for NASH. Multiple large-scale studies have shown that moderate coffee consumption significantly reduces the risk of chronic liver disease. Caffeine, coffee's primary bioactive compound, exerts hepatoprotective effects primarily through A2A receptor inhibition. As a significantly more potent and selective A2A receptor antagonist than caffeine, VG081821 is designed to deliver these proven benefits with enhanced therapeutic precision.

VG081821 distinguishes itself from traditional A2A receptor antagonists such as istradefylline through its unique pharmacological profile. While conventional antagonists simply block receptor activation, VG081821—the only A2A inverse agonist currently in global clinical development—further suppresses the receptor's constitutive basal activity. This dual mechanism enables more complete inhibition of pathological signaling, potentially delivering superior pharmacological effects compared to standard antagonists.

VG081821's first indication is Parkinson's disease, where it represents the only investigational therapy globally that addresses both symptoms and underlying disease mechanisms. In completed Phase II trials of early-to-mid-stage Parkinson's disease, VG081821 demonstrated significant improvements in motor function, meeting all efficacy expectations and showing strong potential as a monotherapy. The primary observed adverse event was transient elevation of liver transaminases—likely a pharmacological consequence of accelerated hepatic de-lipidation and enhanced gluconeogenesis (a processes requiring transaminase participation) rather than a toxic effect. Similar transient transaminase elevations have been observed with other lipid-modifying agents, including fibrates and resmetirom (for NASH), and are generally considered benign adaptive physiological responses. This finding further validates the expected pharmacological effects of VG081821 from an alternative perspective.

"We are thrilled to receive the IND approval to advance VG081821 for NASH therapy," said Sanxing Sun, President and CEO of Vimgreen Pharmaceuticals. "Its mechanism of action is highly differentiated from current THR-beta agonists and GLP-1 therapies. By leveraging the drug's unique ability to restore hepatic lipophagy while simultaneously resolving inflammation and fibrosis, we are well-positioned to address the substantial unmet need in metabolic liver diseases and poised to deliver superior patient outcomes."

Vimgreen expects to initiate a Phase IIa trial for NASH treatment in the second half of the year.

About Vimgreen Pharmaceuticals

Vimgreen is a clinical-stage pharmaceutical company based in Hangzhou, China. The company is dedicated to developing novel therapeutics targeting adenosine signaling pathways, with a focus on addressing unmet medical needs in neurodegenerative, metabolic, and inflammatory diseases. Vimgreen's pipeline includes two clinical-stage compounds: VG081821, an A2A receptor antagonist for Parkinson's disease and NASH; and VG290131, an A3 receptor agonist for autoimmune and inflammatory diseases.

Forward Looking Statements

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