Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC 68498 · 1 trial · 1 indication
To assess the safety and tolerability of single dose administered
| Arm | Type | Description |
|---|---|---|
| HEC68498 | EXPERIMENTAL | administered once on first day in each Treatment Period， HEC68498 VS placebo 3:1 ratio |
| placebo | PLACEBO_COMPARATOR | administered once on first day in each Treatment Period |
| Name | Type | Description |
|---|---|---|
| HEC 68498 | DRUG | HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib. |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening. 2. Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. In good health, determined by no clinically significant findings from medical history,physical examination, 12-l...
| 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 |
HEC 68498 is an investigational small molecule being studied for Idiopathic Pulmonary Fibrosis and Advanced Refractory Solid Tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.
HEC 68498 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM.
HEC 68498 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and tolerability.
HEC 68498 has been studied in two completed Phase 1 trials. NCT03502902 evaluated safety, tolerability, and pharmacokinetics in healthy volunteers with Idiopathic Pulmonary Fibrosis. NCT04324372 studied the drug in patients with Advanced Refractory Solid Tumors.
Yes, HEC 68498 is the same drug as HEC68498. The name is sometimes written with or without a space, but it refers to the same investigational small molecule being developed by Sunshine Biopharma Inc.