Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC585 · 7 trials · 3 indications
change in %FVC, measured using Spirometer, from baseline to week 24
To determine the mass balance recovery of orally administered \[14C\]-HEC585
Area under the curve from 0 to 24 hours under steady-state conditions for HEC585 and Pirfenidone
Maximum Observed Plasma Concentration under steady-state conditions for Pirfenidone and HEC585
Observed Plasma Concentration under steady-state conditions for HEC585 and Nintedanib
To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
area under the plasma concentration-time curve (AUC) from time zero to infinity
time of the maximum observed plasma concentration
apparent volume of distribution
apparent terminal elimination half-life
apparent oral clearance
| Arm | Type | Description |
|---|---|---|
| HEC585 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| pirfenidone | ACTIVE_COMPARATOR | - |
| HEC585 dose A | EXPERIMENTAL | Drug: HEC585 dose A once daily, up to 24 weeks-120 weeks |
| HEC585 dose B | EXPERIMENTAL | Drug: HEC585 dose B once daily, up to 24 weeks-120 weeks |
| HEC585 dose C | EXPERIMENTAL | Drug: HEC585 dose C once daily, up to 24 weeks-120 weeks |
| [14C]-HEC585 | EXPERIMENTAL | \[14C\]-HEC585,solid powder，200 mg/100 µCi,single dose，oral |
| HEC585 and Pirfenidone | EXPERIMENTAL | The DDI study of HEC585 and Pirfenidone |
| HEC585 and Nintedanib | EXPERIMENTAL | The DDI study of HEC585 and Nintedanib |
| A single dose HEC585（pilot trial arm） | EXPERIMENTAL | Healthy subjects receive a single dose of HEC585 |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 1） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 2） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single and Mulltiple doses HEC585（ Part 1, Cohort 3） | EXPERIMENTAL | Healthy subjects receive Single and multiple doses of HEC585 or matching placebo |
| Single dose of HEC585 （Part 2，Fed/Fasting） | EXPERIMENTAL | Following an overnight fast of at least 10 hours, a single dose of HEC585 will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions. |
| two-period study at 400 mg dose group (part 3，Fed) | EXPERIMENTAL | Healthy subjects receive Single/multiple doses of HEC585 or matching placebo in two cycles. |
| A single dose HEC585（A1） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A2） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585/FE（A3） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing |
| A single dose HEC585（A4） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A5） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A6） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A7） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| A single dose HEC585（A8） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B1） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B2） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B3） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B4） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B5） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Multiple doses HEC585（B6） | EXPERIMENTAL | Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule |
| Name | Type | Description |
|---|---|---|
| HEC585 | DRUG | HEC585 tablet, taken once daily |
| Placebo | DRUG | HEC585 Simulation Board, taken once daily |
| Pirfenidone | DRUG | Pirfenidone, taken three times a day |
| [14C]-HEC585 | DRUG | Single Dose = Solution containing 200 mg/100 µCi \[14C\]-HEC585 |
| Nintedanib | DRUG | DDI of HEC585 andNintedanib：Nintedanib，twice a day，D1-D7 and D30-D36 |
Inclusion Criteria: 1. Voluntarily participate in this clinical study and sign the informed consent form before the study begins; 2. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted; 3. Be diagnosed with IPF...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
HEC585 is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a chronic lung disease. It is also studied in healthy volunteers for safety and pharmacokinetic trials. The drug is not yet approved and is currently in clinical development.
HEC585 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Idiopathic Pulmonary Fibrosis.
HEC585 is in Phase 3 clinical development. A confirmatory Phase 3 study (NCT07082842) is currently recruiting patients with Idiopathic Pulmonary Fibrosis in China. Earlier Phase 1 and Phase 2 trials have been completed or are active, but the drug remains investigational.
HEC585 is being studied in several clinical trials. A Phase 3 confirmatory study (NCT07082842) is recruiting IPF patients in China. A Phase 2 study (NCT05060822) is active but not recruiting. Completed Phase 1 trials include NCT03092102 and NCT05468346, which evaluated safety and pharmacokinetics.
HEC585 is not FDA approved. It is an investigational drug currently in clinical development, with an ongoing Phase 3 trial in China for Idiopathic Pulmonary Fibrosis. The drug has not completed the regulatory approval process and remains under study.