SYH2059 / CSPC Pharma - LARVOL DELTA

A Phase II Study to Evaluate the Efficacy and Safety of SYH2059 Tablets in Adult Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: InnovStone Therapeutics Limited

New P2 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SYH2059 Powder for Inhalation (clinicaltrials.gov) - P1 | N=84 | Not yet recruiting | Sponsor: InnovStone Therapeutics Limited

New P1 trial

CSPC Wins U.S. FDA Nod to Trial Novel Inhaled Drug for Pulmonary Fibrosis (TipRanks) - "CSPC Pharmaceutical Group has received U.S. Food and Drug Administration clearance to begin clinical trials of SYH2059, a novel Class 1 chemical drug delivered as an inhaled powder and designed as a highly selective phosphodiesterase 4B inhibitor...Preclinical studies showed superior efficacy to existing therapies in animal models, favorable pharmacokinetics and a broad safety margin, supporting its advancement into human studies."

IND • Idiopathic Pulmonary Fibrosis

Yishi Pharmaceutical's SYH2059 tablets have initiated Phase I clinical trials for interstitial lung disease. [Google translation] (Sina Corp) - "The clinical trial registration number is CTR20253374, and the first public disclosure date is August 25, 2025...The drug is available as tablets in 0.25 mg and 3 mg strengths. Dosage and administration include single oral administration on an empty stomach or after a meal, and multiple oral administration twice daily. The primary objective of this trial was to evaluate the safety and tolerability of multiple oral administration of SYH2059 tablets in healthy subjects....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 42 participants."

Trial status • Interstitial Lung Disease