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IncobotulinumtoxinA

Phase 2

Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury | Monoclonal antibody | Neurology |cbdMD, Inc.|Last Updated: May 5, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

IncobotulinumtoxinA · 1 trial · 1 indication

Phase 2 1
NCT06091020A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve InjuryModerate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury
COMPLETED123 Analytics
PHASE2COMPLETED
A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury
Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve InjuryUnlock trial analytics

Study Endpoints

Primary Endpoints

Weekly averages of changes from baseline in Average Daily Pain (ADP) intensity at Weeks 2 to 12.
Baseline to week 2 to 12

Secondary Endpoints

Changes from baseline in Neuropathic Pain Symptom Inventory (NPSI) total score at Weeks 2 to 12
Baseline to week 2 to 12
Incidence of treatment-emergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
Baseline to week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NT 201EXPERIMENTALSubcutaneous injections of up to 300 units NT 201 into the peripheral neuropathic pain area
PlaceboPLACEBO_COMPARATORSubcutaneous injections of placebo into the peripheral neuropathic pain area

Interventions

NameTypeDescription
IncobotulinumtoxinABIOLOGICALSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
PlaceboBIOLOGICALSolution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Chronic peripheral neuropathic pain that persists for at least 6 months by the time of the screening visit and is plausibly related to either an episode of herpes zoster or a peripheral nerve injury (caused by surgery or mechanical trauma). * Documented diagnosis of either chr...

Countries:BulgariaFranceGermanyHungaryPolandSpain
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Frequently asked questions about IncobotulinumtoxinA

What is IncobotulinumtoxinA used for?

IncobotulinumtoxinA is being investigated for the treatment of moderate to severe chronic peripheral neuropathic pain (PNP) due to postherpetic neuralgia (PHN) or peripheral nerve injury. It is an investigational therapy in Phase 2 clinical development for this indication.

What does IncobotulinumtoxinA target?

IncobotulinumtoxinA is a monoclonal antibody. Its specific molecular target has not been disclosed in the available clinical trial information.

Who makes IncobotulinumtoxinA?

IncobotulinumtoxinA is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD.

What phase is IncobotulinumtoxinA in?

IncobotulinumtoxinA is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities for the treatment of chronic peripheral neuropathic pain.

What clinical trials is IncobotulinumtoxinA in?

IncobotulinumtoxinA has one completed Phase 2 clinical trial, identified as NCT06091020. This randomized, double-blind, placebo-controlled study enrolled 123 participants aged 18 years and older with chronic nerve pain after shingles or nerve injury, and was conducted in Bulgaria, France, Germany, Hungary, Poland, and Spain.