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OROS paliperidone

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment895

FDA Designations

No designations recorded

Clinical trial landscape

OROS paliperidone · 4 trials · 1 indication

Phase 3 2Phase 1 2
NCT00645307A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.Schizophrenia
COMPLETED235 Analytics
NCT00650793A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With SchizophreniaSchizophrenia
COMPLETED473 Analytics
PHASE3COMPLETED
A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
Schizophrenia
NCT00645307235
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PHASE3COMPLETED
A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia
Schizophrenia
NCT00650793473
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Study Endpoints

Primary Endpoints

Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone.
to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in ambulant healthy men; to evaluate the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions
A non-inferiority comparison of the orthostatic tolerability of a higher initial dose of paliperidone OROS with the current recommended initial dose of risperidone in patients with schizophrenia

Secondary Endpoints

Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures
Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters
to evaluate the safety and tolerability of the treatments in healthy men
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Extended Release OROS® PaliperidoneDRUG -
Extended release OROS paliperidoneDRUG -
extended-release (ER) OROS paliperidoneDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301 * Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated * Who signed the informed cons...

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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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Frequently asked questions about OROS paliperidone

What is OROS paliperidone used for?

OROS paliperidone is an investigational small molecule being developed for the treatment of schizophrenia. It is an extended-release formulation of paliperidone, designed to be taken once daily. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes OROS paliperidone?

OROS paliperidone is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the safety and efficacy of this extended-release paliperidone formulation in patients with schizophrenia.

What phase is OROS paliperidone in?

OROS paliperidone is in Phase 3 clinical development for schizophrenia. It is an investigational drug, meaning it has not yet received regulatory approval. The development program includes completed Phase 3 studies, as well as earlier Phase 1 trials, all of which have been completed.

What clinical trials is OROS paliperidone in?

OROS paliperidone has been studied in four completed clinical trials. These include two Phase 3 open-label extension studies (NCT00645307 and NCT00650793) evaluating long-term safety and tolerability, a Phase 1 study comparing it to immediate-release risperidone (NCT00791232), and a Phase 1 pharmacokinetic study (NCT00838669). Total enrollment across these trials was 895 participants.

How does OROS paliperidone work?

OROS paliperidone is an extended-release formulation of paliperidone, an atypical antipsychotic. It works by targeting dopamine and serotonin receptors in the brain, which helps to manage the symptoms of schizophrenia. The OROS delivery system provides controlled release of the medication over a 24-hour period.

Is OROS paliperidone the same as paliperidone ER?

OROS paliperidone is an extended-release (ER) formulation of paliperidone. The clinical trials refer to it as paliperidone ER or ER OROS paliperidone. It is designed to release the active ingredient gradually, which may allow for once-daily dosing compared to immediate-release formulations.