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JZP150

Phase 2

Post Traumatic Stress Disorder | Small molecule | Psychiatry |Jazz Pharmaceuticals plc|Trials Updated: Dec 31, 2024

JZP150 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2022

JZP150 target and mechanism

Molecular targetFAAH
Target classEnzyme
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment282

FDA Designations

No designations recorded

JZP150 clinical trials

JZP150 · 1 trial · 1 indication

Phase 2 1
NCT05178316A Study of JZP150 in Adults With Posttraumatic Stress DisorderPost Traumatic Stress Disorder
COMPLETED282 Analytics
PHASE2COMPLETED
A Study of JZP150 in Adults With Posttraumatic Stress Disorder
Post Traumatic Stress DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline to Week 12 in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) Total Symptom Severity Score
Baseline to Week 12

Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered, clinical interview where participants report on their symptoms of PTSD on a scale. The CAPS-5 total score ranges between 0 and 80. Higher scores indicate more severe PTSD symptoms. Change in CAPS-5 total score is being reported, where negative mean scores indicate an improvement in clinical outcome.

Secondary Endpoints

Mean Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)
Baseline to Week 12
Mean Change From Baseline to Week 12 in Patient Global Impression of Severity (PGI-S)
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JZP150 0.3 mgEXPERIMENTALParticipants who will be randomized to receive JZP150 0.3 mg orally once daily for up to 12 weeks.
JZP150 4.0 mgEXPERIMENTALParticipants who will be randomized to receive JZP150 4.0 mg orally once daily for up to 12 weeks.
PlaceboPLACEBO_COMPARATORParticipants who will be randomized to receive placebo orally once daily for up to 12 weeks.

Interventions

NameTypeDescription
JZP150DRUGOral administration of JZP150 once daily in the morning
PlaceboDRUGOral administration of placebo once daily in the morning
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion Criteria: * Participants aged 18 to 70 years * Participants must be outpatients with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) defined PTSD confirmed by the clinical interview * PTSD is primary diagnosis Exclusion Criteria: * Acute...

Countries:United States
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Frequently asked questions about JZP150

What is JZP150 used for?

JZP150 is an investigational small molecule being developed for the treatment of post traumatic stress disorder (PTSD) in adults. It is a Phase 2 clinical-stage candidate from Jazz Pharmaceuticals plc and has been studied in a placebo-controlled trial in adults aged 18 years and older with PTSD.

What does JZP150 target?

JZP150 targets fatty acid amide hydrolase (FAAH), an enzyme. By acting on FAAH, JZP150 is designed to modulate the endocannabinoid system, which is being explored as a therapeutic approach in post traumatic stress disorder. FAAH is the only molecular target identified for JZP150.

Who is developing JZP150?

JZP150 is being developed by Jazz Pharmaceuticals plc, which trades on Nasdaq under the ticker JAZZ. The company is the sponsor behind the Phase 2 clinical program evaluating JZP150 in adults with post traumatic stress disorder.

What phase is JZP150 in?

JZP150 is in Phase 2 clinical development for post traumatic stress disorder. It is an investigational therapy and is not approved for any indication. Its Phase 2 trial in adults with PTSD has been completed, and no trials of JZP150 are currently active.

What clinical trials is JZP150 in?

JZP150 has been evaluated in one clinical trial, NCT05178316, titled A Study of JZP150 in Adults With Posttraumatic Stress Disorder. This completed Phase 2 trial enrolled 282 adults aged 18 and older in the United States. It was randomized, double blind, and placebo controlled, and did not include healthy volunteers.