Recent Updates
Recently added Catalysts

IR OROS paliperidone and OROS paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00796276A Study of Paliperidone Enantiomer Disposition With Different Formulations and the Bioavailability of Immediate- and Extended-release PaliperidonePHASE1 COMPLETED 20 — — May 1, 2004Aug 1, 2004Jun 8, 2011 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To characterize and document the pharmacokinetics of paliperidone in plasma and urine;the (+) and (-) paliperidone ratio;the possible interconversion between the (+)- and (-)- enantiomers of paliperidone;the absolute oral bioavailability of paliperidone
Secondary Endpoints
To document the possible relationship between the volunteer's CYP2D6 phenotype and the disposition of the (+) and (-) enantiomers of paliperidone and to evaluate the safety and tolerability of the treatments in healthy volunteers
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
IR OROS paliperidone and ER OROS paliperidoneDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Known dextromethorphan (i.e., previously determined) metabolic ratio of \<0.02 or \>0.35, as determined according to the standard procedures of the study center * Acceptable weight as defined by body mass index (weight \[kg\]/height \[m²\]) range of 18 to 28 kg/m², inclusive *...

Unlock Eligibility Criteria
Competitive Landscape -Schizophrenia 38 trials
CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568, NBI-1117570
Bristol-Myers Squibb CompanyBMY9PHASE3KarXT, KarX-EC, Xanomeline and Trospium Chloride, xanomeline and trospium chloride therapy, Xanomeline and trospium chloride
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM, Olanzapine
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Novartis AG Sponsored ADRNVS1PHASE2GXV813
MapLight Therapeutics, Inc.MPLT2PHASE2ML-007C-MA
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Unity Health TorontoUBX1NAUndisclosed
Unlock Competitive Intelligence