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NMDAE

Phase 2

Schizophrenia | Small molecule | Psychiatry |China Pharma Holdings, Inc.|Last Updated: Mar 24, 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_CONTROLLEDDMC
Total Trials2
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04745143Monotherapy of an NMDA Enhancer for SchizophreniaPHASE2 RECRUITING 80Jan 1, 2018Dec 1, 2027Mar 24, 20261 Taiwan
NCT04917302Combination of NMDA-enhancing and Anti-inflammatory Treatments for SchizophreniaPHASE2 RECRUITING 60Oct 13, 2020Dec 1, 2026Feb 19, 20251 Taiwan
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Study Endpoints
Primary Endpoints
Change of Positive and Negative Syndrome Scale (PANSS)
week 0, 2, 4, 6

Assessment of overall symptoms. Minimum value: 30, maximum value:210, the higher scores mean a worse outcome.

Change of scales for the Assessment of Negative Symptoms (SANS) total score
week 0, 2, 4, 6

Assessment of negative symptoms. Minimum value: 0, maximum value:100, the higher scores mean a worse outcome.

Secondary Endpoints
Positive subscale, Negative subscales, and General Psychopathology subscale of Positive and Negative Syndrome Scale (PANSS)
week 0, 2, 4, 6
Clinical Global Impression
week 0, 2, 4, 6
Global Assessment of Functioning
week 0, 2, 4, 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NMDAEEXPERIMENTALAn NMDA enhancer
PlaceboPLACEBO_COMPARATORPlacebo
NMDAE plus Anti-inflammatory Agent (AIFA)EXPERIMENTALAn NMDA enhancer plus a drug with anti-inflammatory property
NMDAE plus PlaceboPLACEBO_COMPARATORAn NMDA enhancer plus Placebo
Interventions
NameTypeDescription
NMDAEDRUGUse of an NMDA enhancer for the treatment of schizophrenia
Placebo CapDRUGUse of placebo as a comparator
NMDAE plus AIFADRUGUse of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of schizophrenia.
NMDAE plus Placebo CapDRUGUse of an NMDA enhancer plus placebo as a comparator
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia * Refuse or are unable to tolerate antipsychotics due to poor response or adverse effects * PANSS total score ≥ 60 * Free of antipsychotic drugs for at least 1 week * Agree to participate in the study a...

Countries:Taiwan
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04745143studyFirstPostDate: changed