loberamisal (Y-3) / NeuroDawn, China Medical System - LARVOL DELTA

Pharmacokinetic Effect of Y-3 for Injection on Rosuvastatin Calcium Tablets in Healthy Participants (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Neurodawn Pharmaceutical Co., Ltd.

New P1 trial

NUWA-Y3: Y-3 for Injection in the Treatment of Acute Ischemic Stroke (clinicaltrials.gov) - P3 | N=998 | Completed | Sponsor: Beijing Tiantan Hospital | Recruiting ➔ Completed

Trial completion • Cardiovascular • Ischemic stroke

A Phase 1 Study of Y-3 in US Healthy Volunteers. (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Neurodawn Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Apr 2025 ➔ Sep 2025

Trial completion • Trial primary completion date

CMS (867/8A8): NDA of Innovative Drug Y-3 for Injection for Acute Ischemic Stroke Accepted in China (The Manila Times) - "The results of Phase II clinical trial of the Product in China indicated that among patients with ischemic stroke within 48 hours of onset, patients in the Y-3 group (40mg, qd) demonstrated a significantly higher proportion of patients achieving an excellent functional outcome (mRS of 0-1) at 90 days than those in the placebo group, with a rate difference of 16%. The Phase III clinical trial of the Product in China was conducted by Beijing Tiantan Hospital, Capital Medical University as the leading site."

China filing • Ischemic stroke

Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Neurodawn Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Study on the Efficacy and Safety of Treating Acute Large Hemispheric Infarction by Injecting RK-4 Injection through the Skull Bone Marrow — A Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint Clinical Study (ChiCTR) - P2 | N=194 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Fuzhou Neurodawn Rongkang Biomedical Technology Co., LTD

New P2 trial

A single-arm, open-label, blind-endpoint Ib/IIa study investigating the treatment of acute large cerebral hemisphere infarction with RK-4 injection through cranial bone marrow (ChiCTR) - P1/2 | N=18 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Fuzhou Neurodawn Rongkang Biomedical Technology Co., LTD

New P1/2 trial

RK-4 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction (clinicaltrials.gov) - P2 | N=194 | Not yet recruiting | Sponsor: Fuzhou Neurodawn Rongkang Pharmaceutical Co., Ltd

New P2 trial • Cardiovascular • Ischemic stroke

Y-3 Intracalvariosseous Injection in Treatment of Acute Large Hemispheric Infarction (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: Neurodawn Pharmaceutical Co., Ltd.

New P1/2 trial • Cardiovascular