sufenidone (SC1011) / Guangzhou JOYO Pharma - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetics of SC1011 (Sufenidone), a Novel Antifibrotic Small Molecule, in Phase 1 Studies in Healthy Subjects. (PubMed, Clin Transl Sci) - "Exposure-adverse event (AE) analysis with the most frequent AEs identified Cmax rather than total exposure as a good predictor of AEs. Compared to the IR formulation, SC1011 MR demonstrated improved exposure and tolerability, supporting its further development in patients with IPF."

Clinical • Journal • P1 data • PK/PD data • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Guangzhou JOYO Pharma Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The Safety, Tolerability, and Pharmacokinetic Study of SC1011 in Healthy Subjects. (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Guangzhou JOYO Pharma Co., Ltd

New P1 trial • Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases