Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
3 ampoules of SHPL-49 · 1 trial · 1 indication
Proportion of participants with mRS scores of 0-1 at Day 90
| Arm | Type | Description |
|---|---|---|
| SHPL-49 Injection，3 ampoules | EXPERIMENTAL | 1mL/ampoule |
| SHPL-49 Injection，6 ampoules | EXPERIMENTAL | 1mL/ampoule |
| Placebo | PLACEBO_COMPARATOR | 1mL/ampoule |
| Name | Type | Description |
|---|---|---|
| 3 ampoules of SHPL-49 Injection | DRUG | 3 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days. |
| 6 ampoules of SHPL-49 Injection | DRUG | 6 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days. |
| 0.9% Sodium Chloride Injection | DRUG | 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days. |
Inclusion Criteria: 1. Age 18-80 years old (including upper and lower limits); 2. Clinically diagnosed as acute ischemic stroke according to the latest guidelines; 3. Patients with acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this researc...
SHPL-49 is an investigational small molecule being developed for the treatment of acute ischemic stroke. It is administered as an injection and is currently in clinical development, having completed a Phase 2 trial in China.
The molecular target of SHPL-49 has not been disclosed. It is a small molecule being studied for its safety and efficacy in patients with acute ischemic stroke, but its specific mechanism of action is not publicly available.
SHPL-49 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials for this drug in China.
SHPL-49 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug is not yet approved by regulatory authorities. It remains an investigational agent for acute ischemic stroke.
SHPL-49 has one completed Phase 2 clinical trial registered as NCT06202378, titled 'Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke.' This randomized, double-blind, placebo-controlled trial enrolled 270 participants in China.