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HEC585 dose A

Phase 2

Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF) | Small molecule | Respiratory |Sunshine Biopharma Inc.|Last Updated: Apr 24, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

HEC585 dose A · 1 trial · 1 indication

Phase 2 1
NCT05139719A 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) PatientsProgressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
RECRUITING110 Analytics
PHASE2RECRUITING
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
Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline to Week 24 in FVC (mL) compared with placebo
24 Weeks

change in FVC (mL), measured using Spirometer, from baseline to week 24

Secondary Endpoints

Change from Baseline to Week 12 in FVC (mL) compared with placebo
12 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 10%
24 Weeks
Proportion of subjects with the decline from baseline in FVC (% predicted) > 5%
24 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HEC585 tables does AEXPERIMENTAL -
HEC585 tables does BEXPERIMENTAL -
placeboPLACEBO_COMPARATORPlacebo once daily up to 24 weeks in main stage; HEC585 dose A once daily up to 96 weeks in extended stage

Interventions

NameTypeDescription
HEC585 dose ADRUGtaking HEC585 dose A orally once daily, up to 24 weeks in main stage (if applicable); up to 96 weeks in extended stage
HEC585 dose BDRUGtaking HEC585 dose B orally once daily, up to 24 weeks in main stage; up to 96 weeks in extended stage
PlaceboDRUGtaking Placebo orally once daily, up to 24 weeks in main stage
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Volunteer to participate and sign the ICF. 2. Male or female patients' age ≥ 18 years when signing the ICF. 3. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investi...

Countries:China
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Recent Changes (Last 90 Days)

LOWJul 5, 2026NCT05139719primaryCompletionDate: changed
LOWJul 5, 2026NCT05139719primaryCompletionDate: changed
LOWJul 5, 2026NCT05139719primaryCompletionDate: changed

Frequently asked questions about HEC585 dose A

What is HEC585 dose A used for?

HEC585 dose A is an investigational small molecule being studied for the treatment of Progressive Fibrosing Interstitial Lung Disease (PF-ILD) and Progressive Pulmonary Fibrosis (PPF). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes HEC585 dose A?

HEC585 dose A is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with PF-ILD and PPF.

What phase is HEC585 dose A in?

HEC585 dose A is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials for the treatment of Progressive Fibrosing Interstitial Lung Disease and Progressive Pulmonary Fibrosis.

What clinical trials is HEC585 dose A in?

HEC585 dose A is being studied in a Phase 2 clinical trial registered as NCT05139719. This randomized, double-blind, placebo-controlled trial is recruiting approximately 110 participants in China to evaluate the drug's effect on delaying forced vital capacity decline in patients with PF-ILD and PPF.

Is HEC585 dose A the same as HEC585?

HEC585 dose A is a specific dose of the drug HEC585. The clinical trial NCT05139719 is designed to explore the therapeutic effect of HEC585 on delaying forced vital capacity decline in patients with Progressive Fibrosing Interstitial Lung Disease, and HEC585 dose A refers to one of the doses being tested in this study.