Recent Updates
Recently added Catalysts

JZP269

Phase 1

Undisclosed | Small molecule | Other |Jazz Pharmaceuticals plc|Trials Updated: Sep 10, 2026

JZP269 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment188

FDA Designations

No designations recorded

JZP269 clinical trials

JZP269 · 1 trial · 1 indication

Phase 1 1
NCT07813663A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female ParticipantsHealthy Participants
NOT YET_RECRUITING188 Analytics
PHASE1NOT YET_RECRUITING
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Reporting Treatment-emergent Adverse Events
Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269
Predose up to 48 hours postdose
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269
Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269
Predose up to 48 hours postdose
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP269
Predose up to 48 hours postdose

Area under the concentration-time curve from time 0 to 24 hours (AUC0-24), area under the concentration time curve from time 0 to the last measurable concentration (AUC0-last), and area under the concentration-time curve from time 0 to infinity will be assessed (AUC∞).

Pharmacokinetic Parameter Oral Clearance (CL/F) of JZP269
Predose up to 48 hours postdose
Pharmacokinetic Parameter Apparent Volume of Distribution During the Terminal Phase (Vz/F) of JZP269
Predose up to 48 hours postdose

Secondary Endpoints

Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)
Predose up to 48 hours postdose
Dose Proportionality of JZP269 Maximum Concentration (Cmax)
Predose up to 48 hours postdose
The Effect of Food on the PK of JZP269 Cmax
Predose up to 48 hours postdose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JZP269EXPERIMENTALParticipants will receive JZP269.
PlaceboPLACEBO_COMPARATORParticipants will receive a matching placebo.

Interventions

NameTypeDescription
JZP269DRUGAdministered as described.
PlaceboDRUGAdministered as described.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is 18 to 55 years of age, inclusive, at the time of signing the informed consent. 2. Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laborat...

Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWSep 10, 2026NCT07813663NEW_TRIAL: changed
LOWSep 10, 2026NCT07813663NEW_TRIAL: changed

Frequently asked questions about JZP269

What is JZP269?

JZP269 is an investigational small molecule being developed by Jazz Pharmaceuticals plc. It is in Phase 1 clinical development and is being studied in healthy adult volunteers. No therapeutic indication for JZP269 has been disclosed.

Who is developing JZP269?

JZP269 is being developed by Jazz Pharmaceuticals plc, which trades on the Nasdaq under the ticker JAZZ. Jazz Pharmaceuticals is the sponsor of the clinical program evaluating JZP269.

What phase is JZP269 in?

JZP269 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants.

What clinical trials is JZP269 in?

JZP269 is being evaluated in one clinical trial, NCT07813663, titled A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants. The trial is a Phase 1 study with an estimated enrollment of 188 participants and has a status of not yet recruiting.

How is the JZP269 Phase 1 trial designed?

The JZP269 Phase 1 trial NCT07813663 is a randomized, double-blind, placebo-controlled study in healthy male and female participants aged 18 years and older. It has an estimated enrollment of 188 participants and is currently listed as not yet recruiting.