VG081821 / Vimgreen Pharma - LARVOL DELTA

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase Ⅱb Clinical Trial to Evaluate the Efficacy and Safety of Oral VG081821AC Tablets as Monotherapy (without concomitant levodopa administration) in Patients with Early-to-Moderate Parkinson’s Disease (ChiCTR) - P2 | N=152 | Not yet recruiting | Sponsor: Capital Medical University Xuanwu Hospital; Capital Medical University Xuanwu Hospital

Monotherapy • New P2 trial • CNS Disorders • Cognitive Disorders • Mental Retardation • Movement Disorders • Parkinson's Disease • Psychiatry • Sleep Disorder

Phase IIb Clinical Trial to Evaluate the Efficacy and Safety of VG081821AC Tablets in Patients With Early to Mid-stage Parkinson's Disease (clinicaltrials.gov) - P2/3 | N=152 | Recruiting | Sponsor: Zhejiang Vimgreen Pharmaceuticals, Ltd.

Monotherapy • New P2/3 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Vimgreen Pharmaceuticals…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) (PRNewswire) - "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....Vimgreen expects to initiate a Phase IIa trial for NASH treatment in the second half of the year."

New P2a trial • Metabolic Dysfunction-Associated Steatohepatitis

VG081821: A ZM241385-Like A2A Receptor Antagonist With Significant Improvement in Pharmacokinetics. (PubMed, Drug Dev Res) - "In-vitro and in-vivo studies demonstrated VG081821's lower intrinsic clearance and superior pharmacokinetic profile compared to ZM241385. Given that more and more studies indicate that blocking A2A receptors has multiple beneficial effects, VG081821 may have the real potential to become a clinically valuable multi-indication therapeutic agent."

Journal • PK/PD data • ADORA2A

Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson’s Disease (PRNewswire) - "Vimgreen Pharmaceuticals...announced today the completion of enrollment of its Phase 2 clinical trial of VG081821AC...for the treatment of early-to-mid stage Parkinson's disease. A total of 150 participants have been enrolled and randomized into one of three cohorts, a high-dose VG081821 group, a low-dose VG081821 group, and a placebo group at a ratio of 1:1:1...The Phase 2 trial is to be completed in November."

Enrollment closed • Trial completion date • CNS Disorders • Parkinson's Disease