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LT3001 Drug Product

Phase 2

Acute Ischemic Stroke | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Jun 5, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

LT3001 Drug Product · 1 trial · 1 indication

Phase 2 1
NCT05198323A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVTAcute Ischemic Stroke
RECRUITING66 Analytics
PHASE2RECRUITING
A Study to Evaluate the Safety and Efficacy of LT3001 Drug Product in Subjects AIS Undergoing EVT
Acute Ischemic StrokeUnlock trial analytics

Study Endpoints

Primary Endpoints

The occurrence of symptomatic intracranial hemorrhage within 24 hours after the single dosing; clinical deterioration defined as an change in the NIHSS of 4 points or more and confirmed by MRI
Within 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LT3001 Drug ProductEXPERIMENTALAdministered by intravenous infusion
PlaceboPLACEBO_COMPARATORAdministered by intravenous infusion

Interventions

NameTypeDescription
LT3001 Drug ProductDRUGLT3001 Drug Product administered once by intravenous infusion
PlaceboDRUGPlacebo administered once by intravenous infusion
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Subject or subject's legal representative consents to participation by signing the informed consent form (ICF) after receiving full information about the study. 2. Subject is aged 18 to 90 years, inclusive, at the time of Screening (Visit 1). 3. Subject has an NIHSS ≥6. 4. Su...

Countries:United StatesTaiwan
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Frequently asked questions about LT3001 Drug Product

What is LT3001 Drug Product used for?

LT3001 Drug Product is an investigational small molecule being developed for the treatment of acute ischemic stroke. It is currently in Phase 2 clinical development and is being studied in patients undergoing endovascular thrombectomy (EVT). The drug is administered in a hospital setting for this acute neurological condition.

How does LT3001 Drug Product work?

The specific molecular target of LT3001 Drug Product has not been disclosed in available information. It is classified as a small molecule therapeutic intended for acute ischemic stroke. The exact mechanism of action is not publicly detailed, and no target class has been specified for this investigational drug.

Who is developing LT3001 Drug Product?

LT3001 Drug Product is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD. The company is advancing this investigational therapy through clinical trials for acute ischemic stroke, with the drug currently in Phase 2 development.

What phase is LT3001 Drug Product in?

LT3001 Drug Product is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to evaluate the drug's safety and efficacy in patients with acute ischemic stroke.

What clinical trials is LT3001 Drug Product in?

LT3001 Drug Product is being studied in one active Phase 2 clinical trial with the identifier NCT05198323. This randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of the drug in subjects with acute ischemic stroke undergoing endovascular thrombectomy. The trial is recruiting 66 participants in the United States and Taiwan.

Is LT3001 Drug Product the same as other stroke treatments?

LT3001 Drug Product is a distinct investigational small molecule being developed specifically for acute ischemic stroke. No alternative names have been associated with this drug in available information. It is being studied as a potential treatment option for patients undergoing endovascular thrombectomy, but it is not the same as other approved stroke therapies.