memantine nitrate (MN-08) / Magpie Pharma - LARVOL DELTA

Pharmacokinetics, Safety Profile, and Tolerability of MN-08 Tablets after Single and Multiple Ascending Doses in Healthy Chinese Volunteers. (PubMed, Clin Drug Investig) - P1 | "MN-08 exhibited favorable pharmacokinetic characteristics and a good safety and tolerability profile in healthy Chinese subjects across the evaluated dose range. These findings support the progression of MN-08 to phase II studies for the treatment of pulmonary arterial hypertension in Chinese patients."

Clinical • Journal • PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd. | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A multi-center,parallel,open, phase Ⅱa clinical trial study of MN-08 tablets in subjects with mild to moderate hypertension (ChiCTR) - P2 | N=12 | Recruiting | Sponsor: The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital); Guangzhou Magpie Pharmaceuticals Co., Ltd

New P2 trial • Cardiovascular • Hypertension

Preliminary phase 2 trial of the novel first-in-class dual-functional medicine for treatment of Alzheimer's disease demonstrates promising results (Neuroscience 2024) - "MN-08 is a novel first-in-class dual-functional second generation memantine nitrate that effectively antagonizes N-methyl-D-aspartic acid receptors (NMDAR) and concurrently releases nitric oxide (NO) to dilate cerebral blood vessels. Due to MN-08’s superior therapeutic efficacy in animal models of AD and safety profile, a phase 2 clinical study in AD patients has been initiated. The progress of this phase 2 clinical trial will be reported."

P2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd. | Trial completion date: Jun 2024 ➔ Dec 2025 | Initiation date: Jun 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2025

Trial completion date • Trial initiation date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd.

New P1 trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases