Aukontals (edaravone oral) / Auzone Biological, Huadong Medicine - LARVOL DELTA

ORAL EDARAVONE FOR NEUROPROTECTION IN ACUTE ISCHEMIC STROKE (ESOC 2025) - "Among 658 screened patients, 614 were randomized and included in the intention-to-treat population (307 assigned to TTYP-01 and 307 to placebo). At 90 days, excellent outcome (mRS 0–1) occurred in 65.4% of TTYP-01 and 47.1% of control patients (odds ratio, 2.12; 95% confidence interval [CI], 1.53 to 2.94; P < 0.0001). The common odds ratio for a mRS shift toward better outcomes in favor of TTYP-01 was 1.44 (95% CI, 1.08 to 1.91)."

Late-breaking abstract • Cardiovascular • Ischemic stroke

Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Shanghai Auzone Biological Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Autism Spectrum Disorder • Genetic Disorders • IL12A • IL17A • IL1B • IL6 • IL7 • TNFA

Evaluate the Efficacy and Safety of TTYP01 Tablets in Adolescents and Children With ASD (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Shanghai Auzone Biological Technology Co., Ltd.

New P2 trial • Autism Spectrum Disorder • Genetic Disorders • IL12A • IL17A • IL1B • IL6 • IL7 • TNFA

5 months! Huadong Medicine's 1.2 billion new drug has submitted NDA [Google translation] (vbdata.cn) - "On December 25, Auzone Biological announced that its pipeline product TTYP01 Edaravone Tablets...has officially submitted a new drug application (NDA) to the U.S. FDA for the treatment of amyotrophic lateral sclerosis. Auzone expects that the application will be approved by the FDA for marketing in 2025...In July this year, Huadong Medicine obtained the exclusive rights to develop, register, produce and commercialize TTYP01 in China with an initial payment of RMB 100 million and development, registration and sales milestone payments of no more than RMB 1.185 billion."

FDA filing • Financing • Amyotrophic Lateral Sclerosis • CNS Disorders

Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke (clinicaltrials.gov) - P3 | N=614 | Completed | Sponsor: Auzone Biological Technology Pty Ltd

New P3 trial • Cardiovascular • Ischemic stroke

Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Auzone Biological Technology Pty Ltd | Recruiting ➔ Completed | Trial completion date: May 2024 ➔ Dec 2023

Trial completion • Trial completion date

Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Auzone Biological Technology Pty Ltd

New P1 trial