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SHPL-49

Phase 3

Acute Ischemic Stroke | Small molecule | Neurology |HUTCHMED (China) Limited|Last Updated: Jan 6, 2026

Target and mechanism

ModalitySmall molecule

Also known as SHPL-49 Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,096

FDA Designations

No designations recorded

Clinical trial landscape

SHPL-49 · 1 trial · 1 indication

Phase 3 1
NCT07241520Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic StrokeAcute Ischemic Stroke
RECRUITING1,096 Analytics
PHASE3RECRUITING
Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke
Acute Ischemic StrokeUnlock trial analytics

Study Endpoints

Primary Endpoints

Modified Rankin Scale (mRS), with scores of 0-1 at Day 90
90±7 days

Proportion of participants with mRS scores of 0-1 at Day 90

Secondary Endpoints

Modified Rankin Scale (mRS), with scores at Day 90
90±7 days
Modified Rankin Scale (mRS), with scores of 0-2 at Day 90
90±7 days
Barthel index (BI) at Day 90
90±7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SHPL-49 InjectionEXPERIMENTAL3mL/ ampoule
Placebo InjectionPLACEBO_COMPARATOR3mL/ ampoule

Interventions

NameTypeDescription
SHPL-49 InjectionDRUG2 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.
Placebo InjectionDRUG2 ampoules of Placebo Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7days.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 diagnosed as acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this...

Countries:China
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Frequently asked questions about SHPL-49

What is SHPL-49 used for?

SHPL-49 is an investigational small molecule being developed for the treatment of acute ischemic stroke. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes SHPL-49?

SHPL-49 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM.

What phase is SHPL-49 in?

SHPL-49 is currently in Phase 3 clinical development. It is an investigational drug and has not been approved for any use.

What clinical trials is SHPL-49 in?

SHPL-49 is being evaluated in a Phase 3 clinical trial with the identifier NCT07241520. This randomized, double-blind, placebo-controlled study is recruiting 1,096 participants with acute ischemic stroke in China.

Is SHPL-49 the same as SHPL-49 Injection?

Yes, SHPL-49 is also known as SHPL-49 Injection. Both names refer to the same investigational drug being developed for acute ischemic stroke.