ALT001 / Beijing Darwin Cell Biotech - LARVOL DELTA

Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Mar 2027

Enrollment closed • Trial completion date • Immunology • Osteoarthritis • Rheumatology

A Phase II Study of ALT001 in Patients With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.

New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • IL13 • IL4 • IL5

ALT001 Phase II Dose-Finding Clinical Study for the Treatment of Amyotrophic Lateral Sclerosis (ChiCTR) - P2 | N=150 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University

New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders • IL13 • IL4 • IL5 • Plasma NfL

ALT001 in MSA: Expansion Study of ALT001 in Patients With Multiple System Atrophy (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: yilong Wang | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

SPRITE-C: The Study of Safety and Preliminary Efficacy of ALT001 in Patients With MultIple System Atrophy-Cerebellar Type (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: yilong Wang | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy

ALT001, A Stem Cell-Derived Protein Complex, In ALS: Preclinical Efficacy And Early Clinical Signals From A Randomized, Double-Blind Investigator-Initiated Trial (ENCALS 2026) - "These findings provide preliminary evidence of clinical activity. Further controlled studies are warranted to confirm efficacy and define the therapeutic role of ALT001 in ALS."

Preclinical • CNS Disorders • Inflammation • Muscular Atrophy • CSF NfL • NEFL

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Doses of ALT001 in Healthy Chinese Subjects (ChiCTR) - P=N/A | N=64 | Recruiting | Sponsor: Beijing Tiantan Hospital, Capital Medical University; Darwin Origin (Hubei) Biopharmaceutical Co., Ltd.

New trial • Cardiovascular • Ischemic stroke • IL13 • IL4 • IL5

Allyl-substituted ALT001 promotes alternative mitophagy and improves therapeutic outcomes in Alzheimer's disease models. (PubMed, Sci Rep) - "Importantly, ALT001-4a successfully restored mitochondrial and cognitive function in both a cellular AD model and a 5xFAD AD model. These findings suggest that the structural modification of ALT001 can generate derivatives with superior potency and potential for treating Alzheimer's disease and that further optimization could enable the development of ALT001-4a as a viable therapeutic agent for AD."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Metabolic Disorders

SPRITE-C: The Study of Safety and Preliminary Efficacy of ALT001 in Patients With MultIple System Atrophy-Cerebellar Type (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: yilong Wang

New P1 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy

Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology