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ORX142

Phase 1

Excessive Daytime Sleepiness | Small molecule | Other |Centessa Pharmaceuticals plc|Last Updated: Dec 24, 2025

Target and mechanism

Molecular targetOX2R

Target classReceptor

ModalitySmall molecule

Also known as ORX142 Tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC

Total Trials1

Total Enrollment208

FDA Designations

No designations recorded

Clinical trial landscape

ORX142 · 1 trial · 1 indication

Phase 1 1

NCT07082829A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of AgeExcessive Daytime Sleepiness

RECRUITING208 Analytics

PHASE1RECRUITING

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

Excessive Daytime Sleepiness

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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

Arm	Type	Description
Part A: SAD Study in Healthy Adults	EXPERIMENTAL	-
Part B: Food-effect Evaluation in Healthy Adults	EXPERIMENTAL	-
Part C: MAD Study in Healthy Adults	EXPERIMENTAL	-
Part D: Evaluation of a Single Dose in Healthy Older Adults	EXPERIMENTAL	-
Part E: PoC Study in Acutely Sleep-deprived Healthy Adults	EXPERIMENTAL	-

Interventions

Name	Type	Description
ORX142 Tablets	DRUG	ORX142 Tablets
Placebo Tablets	OTHER	Placebo Tablets

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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about ORX142

What is ORX142 used for?

ORX142 is an investigational small molecule being developed for excessive daytime sleepiness. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in healthy adult subjects, including those aged 18 to 80 years.

What does ORX142 target?

ORX142 targets the OX2R receptor, which is the orexin 2 receptor. By acting on this receptor, the drug is intended to address excessive daytime sleepiness. The specific mechanism of action is under investigation in clinical trials.

Who is developing ORX142?

ORX142 is being developed by Centessa Pharmaceuticals plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol CNTA. Centessa is conducting clinical trials to evaluate the safety and efficacy of ORX142.

What phase is ORX142 in?

ORX142 is currently in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The ongoing Phase 1 trial is recruiting participants to study the drug in healthy subjects.

What clinical trials is ORX142 in?

ORX142 is being studied in a Phase 1 clinical trial with the identifier NCT07082829. This trial is recruiting 208 healthy adult subjects in the United States. The study is randomized, double-blind, and controlled, and it includes participants aged 18 to 80 years.

Is ORX142 the same as ORX142 Tablets?

Yes, ORX142 is also known as ORX142 Tablets. The tablet formulation is the form being evaluated in clinical trials. Both names refer to the same investigational drug being developed by Centessa Pharmaceuticals.