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ORX142

Phase 1

Excessive Daytime Sleepiness | Small molecule | Other |Centessa Pharmaceuticals plc|Last Updated: Dec 24, 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
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment208
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07082829A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of AgePHASE1 RECRUITING 208 — — Jun 30, 2025Jun 15, 2026Dec 24, 20253 United States
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Study Endpoints
Primary Endpoints
Part A: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in healthy adult subjects
From enrollment to the Follow-Up Visit 13 days post-discharge

Safety and Tolerability as assessed by AEs and SAEs

Part B: Incidence and severity of Treatment-Emergent Adverse Events of oral single ascending doses of ORX142 in the fasted and fed states
From enrollment to the Follow-Up Visit 13 days post-discharge

Safety and Tolerability as assessed by AEs and SAEs

Part C: Incidence and severity of Treatment-Emergent Adverse Events of oral multiple ascending doses of ORX142 in healthy adult subjects
From enrollment to the Follow-Up Visit 13 days post-discharge

Safety and Tolerability as assessed by AEs and SAEs

Part D: Incidence and severity of Treatment-Emergent Adverse Events of oral single oral doses of ORX142 in healthy older adult subjects
From enrollment to the Follow-Up Visit 13 days post-discharge

Safety and Tolerability as assessed by AEs and SAEs

Part E: Incidence and severity of Treatment-Emergent Adverse Events of oral of single oral doses of ORX142 in acutely sleep-deprived healthy adult subjects
From enrollment to the Follow-Up Visit 13 days post-discharge

Safety and Tolerability as assessed by AEs and SAEs

Secondary Endpoints
Cmax: Maximum Observed Plasma Concentration for ORX142 in subjects receiving ORX142
Pre-dose and multiple post-dose timepoints, up to 48 hours
Tmax: Time of Maximum Concentration for ORX142 in subjects receiving ORX142
Pre-dose and multiple post-dose timepoints, up to 48 hours
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX142 in subjects receiving ORX142
Pre-dose and multiple post-dose timepoints, up to 48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: SAD Study in Healthy AdultsEXPERIMENTAL -
Part B: Food-effect Evaluation in Healthy AdultsEXPERIMENTAL -
Part C: MAD Study in Healthy AdultsEXPERIMENTAL -
Part D: Evaluation of a Single Dose in Healthy Older AdultsEXPERIMENTAL -
Part E: PoC Study in Acutely Sleep-deprived Healthy AdultsEXPERIMENTAL -
Interventions
NameTypeDescription
ORX142 TabletsDRUGORX142 Tablets
Placebo TabletsOTHERPlacebo Tablets
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites3

Key Inclusion Criteria: 1. Healthy males or females as determined by assessments at the Screening Visit. For Parts A, B, C, and E: a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening 2. For Part D: a .Participants must be at least 60 years of ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07082829primaryCompletionDate: changed
LOWMay 24, 2026NCT07082829studyFirstPostDate: changed