yifenidone (HEC585) / HEC Pharm - LARVOL DELTA

Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF (clinicaltrials.gov) - P3 | N=472 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P3 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Potent Antifibrotic Efficacy of Yinfenidone In Vitro and In Vivo Pulmonary Fibrosis Model (ATS 2025) - "Pirfenidone and Nintedanib are the only two licensed therapy drugs for IPF, but about 30% of patients are unable to take them due to side effects...In this study, we investigated the activities of HEC585 in cell-culture assays using primary human lung fibroblasts (HLF), lung organoids from human induced pluripotent stem cells (hiPSC), and in a therapeutic rat model of Bleomycin (Bleo)-induced lung fibrosis... HEC585 showed beneficial effects in vitro HLF and organoids model and was confirmed dose-dependent antifibrotic effect in a therapeutic in vivo rat model of lung fibrosis. Based on pre-clinical studies, HEC585 should be a promising candidate for treating patients with pulmonary fibrosis."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • TGFB1 • VIM

Deep Learning-Based Drug Compounds Discovery for Gynecomastia. (PubMed, Biomedicines) - "DTI analysis and DeepPurpose predictions identified 12 potential drugs, including conteltinib, yifenidone and vosilasarm, with high predicted binding affinities to the target genes. The findings highlight the effectiveness of combining text mining and artificial intelligence in drug discovery. This innovative method provides a new avenue for developing specific treatments for gynecomastia and underscores the need for further experimental validation and optimization of prediction models to support novel drug development."

Journal • IGF1 • TGFB1

A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients (clinicaltrials.gov) - P2b | N=110 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P2 ➔ P2b | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Aug 2023 ➔ Dec 2024

Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Phase ll Study of HEC585 in Patients With IPF (clinicaltrials.gov) - P2 | N=270 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: May 2023 ➔ May 2025 | Trial primary completion date: Feb 2023 ➔ May 2024

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

Study on the Body Mass Balance and Biotransformation of [14C]-HEC585 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion

Study on the Body Mass Balance and Biotransformation of [14C]-HEC585 (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial

To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd.

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

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed

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

Phase ll Study of HEC585 in Patients With PF-ILD (clinicaltrials.gov) - P2; N=110; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P2 trial • Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Phase ll Study of HEC585 in Patients With IPF (clinicaltrials.gov) - P2; N=270; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

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

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1; N=58; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Trial completion date: Dec 2020 ➔ Jun 2021; Trial primary completion date: Dec 2020 ➔ Jun 2021

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

Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC585 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1; N=58; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases

The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects (clinicaltrials.gov) - P1; N=136; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Enrolling by invitation ➔ Completed; N=84 ➔ 136

Clinical • Enrollment change • Trial completion • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Respiratory Diseases