New stroke drug shows promise in early trial

NCT ID NCT07279493

Disease control Sponsor: Kunming Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called KPCXM18 in people who have had an acute ischemic stroke within the past 12 hours. About 300 participants will receive either a low dose, a high dose, or a placebo by IV twice daily for about 12 days. The main goal is to see if the drug helps reduce disability 90 days after the stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KPCXM18 injection
What this could lead to: If successful, this could point toward a new treatment to reduce disability after a stroke.
What could go wrong: This is an early Phase 2b trial with only 300 people, so results may not confirm benefit. The drug is still experimental and safety is not fully known.

Why investors are watching

Kunming Pharmaceuticals is running a Phase 2b trial of its experimental stroke drug, KPCXM18, in 300 patients with acute ischemic stroke. For a small company with few products, this readout is a major test of whether its lead candidate works and is safe, which could shape the company's future value.

If it works: If KPCXM18 shows meaningful benefit over placebo in improving stroke outcomes, the company could advance the drug to later-stage trials and potentially attract partnership interest. A positive result would validate years of research and give the company a credible product in a large treatment area.

If it fails: Most drugs fail in Phase 2 trials, and a negative or unclear result could stall the program and hurt the company's prospects. A delay in enrollment or data readout would also prolong uncertainty for a small firm with limited resources.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\. Age 18 to 80 years old (including 18 years old and 80 years old, based on the date of signing the informed consent form), male or female; * 2.Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 "; * 3.During the screening process, it is required that the ischemic stroke should occur within 12 hours after the onset, and it is expected that the investigational drug can be started within 12 hours after the onset; note: The onset time is calculated from the time when the ischemic stroke symptoms appear, If the onset occurs during sleep, the time of onset should be considered as the last time the patient was observed to be normal; * 4.Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points; * 5.The patients who first attacked, or the patients who had a good prognosis after the last attacked , (mRS score was ≤1 before the onset of the disease ); * 6.The subject has received or plans to receive standard intravenous thrombolysis treatment after this onset; * 7.The subject can understand and follow the research process and voluntarily signs the research informed consent form (the informed consent form is signed by the subject or the legal representative). Exclusion Criteria: * 1\. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc; * 2\. Patients who have received or plan to receive endovascular interventional treatment (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting) or patients with arteriovenous bridging therapy after this onset; * 3\. Patients with disturbance of consciousness (NIHSS score Ia\>1 point); * 4\. Patient has a history of intracranial hemorrhage before; * 5\. Patient who have a history of epilepsy or who experienced epileptic symptoms during a stroke; * 6\. The patient with other mental illness (such as severe mental disorders, dementia) and combined conditions such as limb movement disorders may influence their neurological function tests; * 7\. Patients with acute myocardial infarction, cardiac interventional therapy, or heart failure (grade III and IV according to NYHA) within the past 1 month; * 8\. Patients with malignant tumors, serious diseases of blood, digestion or other systems or diseases with bleeding tendencies (such as hemophilia, etc.), and the expected survival time is not more than 3 months; * 9\. Despite active antihypertensive therapy, hypertension remains uncontrolled: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg; * 10.Patients with severe liver function impairment, or ALT, AST \> 2.0× ULN; * 11.Patients with severe renal impairment, or serum creatinine \> 1.5× ULN; * 12.Patients who have used neuroprotective drugs (including Edaravone, Edaravone Dexborneol, Butylphthalide, Piracetam, Urinary Kallidinogenase, Ginkgolide, Ginkgo Diterpene Lactone, Safflower Extract and Aceglutamide Injection, etc.) after the onset of this illness; * 13.Patients with severe allergies, hypersensitivity to at least two or more types of drugs, or known to be allergic to any ingredient or excipient of the investigational drug; * 14.Patients with a history of major surgery within 1 month before screening; * 15.Patients with a history of drug abuse within 3 month before screening; * 16.Patients who participated in or are currently participating in other clinical trials within 3 month prior to this study; * 17.Pregnancy, lactation. or patients who have a family plan within 3 months of the first dose and who are unwilling to use contraception; * 18.The investigator considers that patients are not suitable for clinical trials.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

23 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Central Hospital Of Shenyang Medical College
RECRUITING

Shenyang, Liaoning, China
Beijing Tiantan Hosptial，Capital Medical University
RECRUITING

Beijing, Beijing Municipality, China
Cangzhou Central Hospital
RECRUITING

Cangzhou, Hebei, China
Da Qing Long Nan Hospital
RECRUITING

Daqing, Heilongjiang, China
Daqing Oilfield General Hospital
RECRUITING

Daqing, Heilongjiang, China
First People's Hospital Of Tancheng
RECRUITING

Linyi, Shandong, China
Hengshui People's Hospital
RECRUITING

Hengshui, Hebei, China
Jiaxing Second Hospital
RECRUITING

Jiaxing, Zhejiang, China
Linfen Central Hospital
RECRUITING

Linfen, Shanxi, China
Linfen People's Hospital
RECRUITING

Linfen, Shanxi, China
Linyi People's Hospital
RECRUITING

Linyi, Shandong, China
Meihakou Central Hospital
RECRUITING

Meihekou, Jilin, China
Nanshi Hospital Of Nanyang
RECRUITING

Nanyang, Henan, China
Nanyang Second General Hospital
RECRUITING

Nanyang, Henan, China
Shenzhen Second People's Hospital
RECRUITING

Shenzhen, Guangdong, China
Sinopharm Tongmei General Hospital
RECRUITING

Datong, Shanxi, China
Tengzhou Central People's Hospital
RECRUITING

Tengzhou, Shandong, China
The First Affiliated Hospital Of Nanyang Medical College
RECRUITING

Nanyang, Henan, China
The First People's Hospital Of Shenyang
RECRUITING

Shenyang, Liaoning, China
The People's Hospital Of Anyang City
RECRUITING

Anyang, Henan, China
The People's Hospital Of Liaoning Province
RECRUITING

Shenyang, Liaoning, China
Xuzhou Central Hospital
RECRUITING

Xuzhou, Jiangsu, China
Yan'an University Xianyang Hospital
RECRUITING

Xianyang, Shaanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.