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PRAX-628

Phase 1

Healthy | Small molecule | Other |Praxis Precision Medicines, Inc.|Last Updated: Feb 21, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06840925A Clinical Trial to Evaluate the Relative Bioavailability of PRAX-628PHASE1 NOT YET_RECRUITING 16 — — Mar 24, 2025Jun 30, 2025Feb 21, 20251 Australia
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Study Endpoints
Primary Endpoints
To assess the relative bioavailability of single 40 mg oral doses of PRAX-628 tablet as compared to PRAX-628 capsules
28 days

Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)

Secondary Endpoints
To evaluate the pharmacokinetics (PK) of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
28 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX-628 capsules
32 days
To evaluate the safety and tolerability of single 40 mg oral doses of PRAX-628 tablet and PRAX 628 capsules
32 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsulesEXPERIMENTAL40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally.
Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tabletEXPERIMENTAL4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally.
Interventions
NameTypeDescription
PRAX-628DRUGOnce daily oral
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight of at least 50 kg with body mass index (BMI) between 18 and 32 kg/m2 * Is in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations * All female...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06840925primaryCompletionDate: changed
LOWMay 24, 2026NCT06840925studyFirstPostDate: changed