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Neflamapimod

Phase 2

Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Small molecule | Other |CervoMed Inc.|Last Updated: Apr 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07033481Clinical Study of Neflamapimod in Patients With Primary Progressive AphasiaPHASE2 RECRUITING 20Oct 2, 2025Oct 1, 2026Apr 22, 20267 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events and Serious Adverse Events.
Baseline to Week 36

The number and proportion of participants experiencing adverse events (AEs) and serious adverse events (SAEs) during the study period, categorized by severity and relationship to the study intervention.

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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NeflamapimodEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NeflamapimodDRUGNeflamapimod is a highly specific inhibitor of the intra-cellular enzyme mitogen-activated protein kinase14 (p38α) provided in 40 mg capsules
PlaceboDRUGPlacebo is a capsule that looks just like neflamapimod but without the active ingredients
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Men and women aged 40-85 years at Screening. * Participant or participant's legally authorized representative (where applicable) is willing and able to provide written informed consent. * Clinical diagnosis of nfvPPA by consensus criteria \[Gorno-Tempini et al, 2011\]. * At...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07033481primaryCompletionDate: changed
LOWMay 24, 2026NCT07033481studyFirstPostDate: changed