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JNJ-89495120

Phase 2

Depressive Disorder, Major | Small molecule | Other |Johnson & Johnson|Last Updated: Jun 5, 2026

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-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment107
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06785012A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive DisorderPHASE2 ACTIVE NOT_RECRUITING 107Dec 26, 2024Jun 26, 2026Jun 5, 202644 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 5
Baseline up to Day 5

The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Secondary Endpoints
Change from Baseline in MADRS Total Score to Day 2
Baseline up to Day 2
Change from Baseline in Clinician Global Impression-Severity (CGI-S) Scale Score to Days 2 and 5
Baseline up to Day 2 and Day 5
Change from Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Total Score to Day 5
Baseline up to Day 5
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: JNJ-89495120 Dose AEXPERIMENTALParticipants will receive JNJ-89495120 dose A during the double-blind (DB) treatment phase in Period 1 and Period 2 of the study.
Arm 2: JNJ-89495120 Dose A and Dose BEXPERIMENTALParticipants will receive JNJ-89495120 dose A in Period 1 followed by JNJ-89495120 dose B in Period 2 during the DB treatment phase of the study.
Arm 3: Placebo GroupPLACEBO_COMPARATORParticipants will receive placebo matched to JNJ-89495120 during the DB treatment phase in Period 1 and Period 2 of the study.
Interventions
NameTypeDescription
JNJ-89495120DRUGJNJ-89495120 will be administered.
PlaceboDRUGPlacebo will be administered.
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Primary psychiatric diagnosis of recurrent major depressive disorder, without psychotic features, based on clinical assessment using diagnostic and statistical manual of mental disorders (DSM)-5 criteria and confirmed with the mini international neuropsychiatric interview (MIN...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 5, 2026NCT06785012Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06785012Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06785012Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 5, 2026NCT06785012Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06785012Enrollment: 124 → 100
LOWMay 24, 2026NCT06785012studyFirstPostDate: changed