Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 3 ampoules of SHPL-49 Injection
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 being developed for the treatment of acute ischemic stroke, a neurological condition in which blood flow to part of the brain is blocked. It is a small molecule therapeutic candidate administered as an injection. HUTCHMED (China) Limited is developing it, and it has been studied in a Phase 2 clinical trial.
SHPL-49 is developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is advancing the small molecule injection candidate for acute ischemic stroke. HUTCHMED conducted the Phase 2 trial evaluating the drug in participants with this condition.
SHPL-49 is in Phase 2 clinical development for acute ischemic stroke. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
SHPL-49 has been evaluated in one completed Phase 2 trial, NCT06202378, titled Safety and Efficacy of SHPL-49 Injection in Participants With Acute Ischemic Stroke. The trial enrolled 270 participants in China, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.
Yes, SHPL-49 and SHPL-49 Injection refer to the same investigational product from HUTCHMED (China) Limited. The injection form is the administered formulation studied in the Phase 2 trial for acute ischemic stroke. Both names describe the same small molecule candidate.