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Usnoflast

Phase 2

Amyotrophic Lateral Sclerosis (ALS) | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Jul 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Usnoflast · 1 trial · 1 indication

Phase 2 1
NCT07023835Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)
RECRUITING240 Analytics
PHASE2RECRUITING
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS)
NCT07023835240
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Study Endpoints

Primary Endpoints

Efficacy of Usnoflast versus placebo assessed using the revised ALSFRS-R total score
From baseline through Week 36

Change in disease progression from baseline through Week 36 as measured by ALSFRS-R total score

Efficacy of Usnoflast versus placebo assessed using the survival
From baseline through Week 36

Change in disease progression from baseline through Week 36 as measured by survival Survival is defined based on the time of death or permanent-assisted ventilation (PAV). PAV is defined as the use of invasive or noninvasive mechanical ventilation for \>22 hours daily for \>7 consecutive days

Effect of Usnoflast versus placebo on survival in Open label extension phase
From baseline through Week 16

Time from baseline to the occurrence of death or Permanent-assisted ventilation (\>22 hours daily for \>7 days)

Number of participants with treatment emergent adverse events in open label extension
From baseline through Week 16

Time from baseline

Number of participants with Serious adverse events in open label extension
From baseline through Week 16

Time from baseline

Secondary Endpoints

Effect of Usnoflast versus placebo on survival
From baseline through Week 36
Evaluate the effect of Usnoflast versus placebo on Slow vital capacity
from baseline to Week 36
Evaluate the effect of Usnoflast versus placebo on serum levels of Neurofilament light chain protein
From baseline to Week 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
50 mg UsnoflastACTIVE_COMPARATOR50 mg Usnoflast capsules and matching placebo of 25 mg capsule under fasting conditions twice a day orally for 36 weeks
75 mg UsnoflastACTIVE_COMPARATOR25 mg + 50 mg Usnoflast capsules under fasting conditions twice a day orally for 36 weeks
PlaceboPLACEBO_COMPARATORMatching placebo of 25 mg and 50 mg under fasting conditions twice a day orally for 36 weeks

Interventions

NameTypeDescription
50 mg UsnoflastDRUG50 mg Usnoflast (50 mg Usnoflast capsules and matching placebo of 25 mg capsule)
75 mg UsnoflastDRUG75 mg Usnoflast (25 mg + 50 mg Usnoflast capsules)
PlaceboDRUGMatching placebo of 25 mg and 50 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria * Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis sy...

Countries:United StatesCanada
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Frequently asked questions about Usnoflast

What is Usnoflast used for?

Usnoflast is an investigational small molecule being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied for its potential to address the progression of this neurological condition.

What does Usnoflast target?

Usnoflast is a small molecule therapeutic being studied for ALS. While its specific molecular target has not been disclosed, it is being evaluated in a Phase 2 clinical trial for its effects on neuromuscular function in patients with ALS. The trial is designed to assess the drug's efficacy and safety in this patient population.

Who makes Usnoflast?

Usnoflast is being developed by cbdMD, Inc., a company publicly traded under the ticker symbol YCBD. The company is conducting a Phase 2 clinical trial to evaluate the drug's potential as a treatment for Amyotrophic Lateral Sclerosis (ALS).

What phase is Usnoflast in?

Usnoflast is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting participants to evaluate the drug's efficacy and safety in patients with Amyotrophic Lateral Sclerosis (ALS).

What clinical trials is Usnoflast in?

Usnoflast is being studied in a Phase 2 clinical trial with the identifier NCT07023835, titled 'Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis.' This randomized, double-blind, placebo-controlled trial is recruiting 240 participants in the United States and Canada.

Is Usnoflast the same as 50 mg Usnoflast?

Yes, Usnoflast is also known as 50 mg Usnoflast. This alternative name refers to the same drug being developed by cbdMD, Inc. for the treatment of Amyotrophic Lateral Sclerosis (ALS). The drug is currently in Phase 2 clinical trials.