Paliperidone is evaluated across numerous clinical trials spanning early to late development phases, with recruitment statuses ranging from active and completed to withdrawn. Supported by pharmaceutical developers like Janssen Pharmaceutica and academic institutions, these studies primarily investigate schizophrenia, schizoaffective disorder, first-episode psychosis, pediatric bipolar disorder, and metabolic side effects. Additionally, several clinical trials focus on long-acting formulations, therapeutic relapse prevention, and comparative multi-omics safety profiles.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07047651 | ACTIVE_NOT_RECRUITING | Treatment Resistant Schizophrenia; Treatment Resistant Bipolar Disorder |
Dr. Stavroula Rakitzi |
2025-06-04 | PHASE4 |
| NCT04478838 | RECRUITING | Schizophrenia and Related Disorders; Drug Administration Schedule; Drug Therapy; Antipsychotic Agents |
Centre for Addiction and Mental Health |
2022-06-06 | PHASE4 |
| NCT07493551 | RECRUITING | Schizophrenia |
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
2024-10-09 | |
| NCT07075237 | NOT_YET_RECRUITING | Schizophrenia |
Jiangsu Province Nanjing Brain Hospital |
2025-10 | PHASE4 |
| NCT07153835 | NOT_YET_RECRUITING | Schizophrenia |
Sher-E-Bangla Medical College |
2025-09-01 | PHASE4 |
| NCT06060886 | UNKNOWN | Schizophrenia; Treatment-resistant Schizophrenia; Side Effect; Lipid Metabolism Disorders; Diabetes; NAFLD; Psychosis |
Consorcio Centro de Investigación Biomédica en Red (CIBER) |
2023-11-01 | PHASE4 |
| NCT07268430 | COMPLETED | Schizophrenia |
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
2023-12-18 | |
| NCT03485417 | COMPLETED | Stimulant Use With Stimulant-Induced Psychotic Disorder (Diagnosis); Schizophrenia and Related Disorders; Stimulant Dependence; Stimulant Abuse; Pharmacotherapy |
The University of Hong Kong |
2019-06-01 | PHASE2; PHASE3 |
| NCT04940039 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2021-07-22 | PHASE4 |
| NCT06060886 | Not yet recruiting | Schizophrenia|Treatment-resistant Schizophrenia|Side Effect|Lipid Metabolism Disorders|Diabetes|NAFLD|Psychosis |
Consorcio Centro de Investigación Biomédica en Red (CIBER)|Instituto de Salud Carlos III |
2023-11-01 | Phase 4 |
| NCT04072575 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2019-09-19 | PHASE3 |
| NCT04922593 | COMPLETED | Schizophrenia; Psychotic Disorders; Mood Disorders; Schizophrenia Spectrum; Mental Disorders; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action |
Luye Pharma Group Ltd. |
2021-01-13 | PHASE1 |
| NCT01451736 | COMPLETED | Schizophrenia (Recent-onset) |
University of California, Los Angeles |
2011-10 | PHASE4 |
| NCT02146547 | COMPLETED | Schizophrenia |
UMC Utrecht |
2015-02 | PHASE4 |
| NCT04572685 | COMPLETED | Schizophrenia Patients |
Luye Pharma Group Ltd. |
2020-01-22 | PHASE1 |
| NCT03345342 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2017-11-20 | PHASE3 |
| NCT03713658 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2018-10-18 | PHASE4 |
| NCT02431702 | COMPLETED | Schizophrenia; Psychotic Disorders |
Janssen Scientific Affairs, LLC |
2015-07-08 | PHASE3 |
| NCT03557931 | COMPLETED | Schizophrenia |
Astellas Pharma Global Development, Inc. |
2018-07-13 | PHASE2 |
| NCT03425552 | COMPLETED | Schizophrenia |
Pharmathen S.A. |
2018-03-11 | PHASE1; PHASE2 |
| NCT03345979 | COMPLETED | Schizophrenia |
Alkermes, Inc. |
2017-11-15 | PHASE3 |
| NCT04076371 | COMPLETED | Schizophrenia |
Beijing HuiLongGuan Hospital |
2012-01 | |
| NCT03080194 | UNKNOWN | Schizophrenia |
Maosheng Fang |
2017-04 | PHASE4 |
| NCT02713282 | COMPLETED | Schizophrenia |
Janssen-Cilag Ltd. |
2016-04-28 | PHASE3 |
| NCT02918825 | COMPLETED | Schizophrenia |
Beijing HuiLongGuan Hospital |
2016-09-01 | |
| NCT02634320 | COMPLETED | Schizophrenia |
Alkermes, Inc. |
2015-12 | PHASE4 |
| NCT02374567 | TERMINATED | Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders |
Hannover Medical School |
2015-01 | PHASE3 |
| NCT04754750 | COMPLETED | Schizophrenics |
Calo Psychiatric Center |
2015-01 | PHASE1; PHASE2 |
| NCT03019887 | COMPLETED | Schizophrenia Relapse |
Juntendo University |
2011-04 | |
| NCT02634463 | COMPLETED | Immunoassay; Antipsychotic |
Janssen Research & Development, LLC |
2015-11-09 | PHASE1 |
| NCT01399450 | COMPLETED | Schizophrenia |
Seoul National University Hospital |
2011-08 | PHASE4 |
| NCT02307396 | COMPLETED | Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders |
Technical University of Munich |
2015-02-01 | PHASE4 |
| NCT02433717 | UNKNOWN | Schizophrenia; Schizoaffective Disorder |
National Taiwan University Hospital |
2015-04 | PHASE4 |
| NCT02462473 | TERMINATED | Schizophrenia; Schizoaffective Disorder |
Janssen Research & Development, LLC |
2015-05 | PHASE2 |
| NCT01860781 | COMPLETED | Schizophrenia |
Seoul National University Hospital |
2011-08 | PHASE4 |
| NCT02532842 | Completed | Schizophrenia |
Janssen Pharmaceutica N.V. Belgium |
2015-07 | -- |
| NCT01670071 | TERMINATED | Schizophrenia |
Johnson & Johnson Taiwan Ltd |
2013-01 | PHASE4 |
| NCT01947803 | COMPLETED | Schizophrenia |
Xian-Janssen Pharmaceutical Ltd. |
2013-09 | PHASE4 |
| NCT01515423 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2012-05 | PHASE3 |
| NCT01685931 | COMPLETED | Schizophrenia |
Xian-Janssen Pharmaceutical Ltd. |
2012-11 | PHASE4 |
| NCT02087579 | COMPLETED | Psychotic Disorders; Schizophrenia; Bipolar Disorder; Depressive Disorder |
Janssen Research & Development, LLC |
2014-02 | PHASE1 |
| NCT01795547 | COMPLETED | Schizophrenia |
H. Lundbeck A/S |
2013-02 | PHASE3 |
| NCT01559272 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2008-02-21 | PHASE1 |
| NCT01825928 | COMPLETED | Methamphetamine Dependence |
Wei Hao |
2013-02 | |
| NCT01529515 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2012-05 | PHASE3 |
| NCT00806234 | COMPLETED | Psychotic Disorders |
Johns Hopkins University |
2009-01 | PHASE4 |
| NCT01134731 | COMPLETED | Major Depressive Disorder; Suicidal Ideation |
University of Alabama at Birmingham |
2010-05 | PHASE4 |
| NCT01584466 | WITHDRAWN | Schizophrenia |
University of Maryland, Baltimore |
2014-01 | |
| NCT01584466 | Withdrawn | Schizophrenia |
University of Maryland Baltimore |
2014-01 | Not Applicable |
| NCT01822730 | COMPLETED | Methamphetamine Dependence |
Wei Hao |
2013-02 | PHASE4 |
| NCT01527305 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2012-06-22 | PHASE4 |
| NCT01157351 | COMPLETED | Schizophrenia |
Janssen Scientific Affairs, LLC |
2010-05 | PHASE4 |
| NCT01742390 | UNKNOWN | Sexual Dysfunction; Hyperprolactinemia |
Si Tianmei |
2013-02 | PHASE4 |
| NCT01448720 | COMPLETED | Schizophrenia |
Janssen-Cilag Farmaceutica Ltda. |
2011-09 | PHASE3 |
| NCT01193153 | COMPLETED | Schizoaffective Disorder |
Janssen Scientific Affairs, LLC |
2010-09 | PHASE3 |
| NCT00632229 | COMPLETED | Obsessive-Compulsive Disorder |
University of South Florida |
2007-10 | PHASE2 |
| NCT01682161 | COMPLETED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2012-01 | PHASE4 |
| NCT01136772 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
New York State Psychiatric Institute |
2011-03 | PHASE4 |
| NCT01592201 | TERMINATED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2012-07 | PHASE4 |
| NCT01051531 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2010-04-22 | PHASE3 |
| NCT01662310 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2011-06 | PHASE3 |
| NCT01081769 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2010-02 | PHASE3 |
| NCT01157585 | COMPLETED | First Episode Psychosis |
Chonbuk National University Hospital |
2010-02 | PHASE4 |
| NCT01281527 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2010-11 | PHASE3 |
| NCT01450514 | COMPLETED | Chronic Schizophrenia; Schizoaffective Disorder |
PharmaNeuroBoost N.V. |
2012-03 | PHASE2 |
| NCT01258920 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2010-10 | PHASE3 |
| NCT01193166 | WITHDRAWN | Schizophrenia |
Ortho-McNeil Janssen Scientific Affairs, LLC |
2010-08 | PHASE4 |
| NCT00488319 | COMPLETED | Schizophrenia; Schizophrenic Disorders; Psychotic Disorders; Dementia Praecox |
Janssen Research & Development, LLC |
2007-06 | PHASE3 |
| NCT01009047 | COMPLETED | Schizophrenia |
Janssen Research & Development, LLC |
2009-12 | PHASE3 |
| NCT01299389 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2010-10 | PHASE3 |
| NCT02075528 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Taipei City Hospital |
2009-07 | PHASE4 |
| NCT01607762 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2012-02 | PHASE1 |
| NCT00975611 | TERMINATED | Schizophrenia; Schizoaffective Disorder |
David C. Henderson, MD |
2009-10 | PHASE4 |
| NCT01050478 | COMPLETED | Psychomotor Agitation; Acute Disease |
Janssen Cilag N.V./S.A. |
2010-03 | PHASE4 |
| NCT01211704 | WITHDRAWN | Bipolar Disorder |
University of Miami |
2010-10 | PHASE4 |
| NCT00915512 | COMPLETED | Schizophrenia |
Janssen-Cilag Turkey |
2009-05 | PHASE4 |
| NCT00827840 | COMPLETED | Schizophrenia |
Chonnam National University Hospital |
2008-11 | PHASE4 |
| NCT00330863 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Northwell Health |
2006-05 | PHASE4 |
| NCT00784238 | COMPLETED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2008-04 | PHASE4 |
| NCT00761579 | COMPLETED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2008-04 | PHASE4 |
| NCT01387542 | COMPLETED | Schizophrenia |
Janssen-Cilag Ltd.,Thailand |
2009-08 | PHASE4 |
| NCT00549562 | COMPLETED | Autism |
Indiana University |
2007-11 | PHASE3 |
| NCT00761605 | COMPLETED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2008-04 | PHASE4 |
| NCT00937261 | UNKNOWN | Schizophrenia |
University of California, Irvine |
2009-07 | PHASE4 |
| NCT01284959 | COMPLETED | Schizophrenia |
Chonbuk National University Hospital |
2010-06 | PHASE4 |
| NCT00761189 | COMPLETED | Schizophrenia |
Janssen Korea, Ltd., Korea |
2008-02 | PHASE4 |
| NCT00490971 | COMPLETED | Bipolar Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-05 | PHASE3 |
| NCT00946985 | TERMINATED | Schizophrenia |
Ortho-McNeil Janssen Scientific Affairs, LLC |
2009-06 | PHASE4 |
| NCT01942382 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2009-04 | PHASE1 |
| NCT01362439 | COMPLETED | Schizophrenia |
Janssen-Cilag S.p.A. |
2009-01 | PHASE4 |
| NCT00934635 | TERMINATED | Schizophrenia |
Janssen-Cilag G.m.b.H |
2009-09 | PHASE4 |
| NCT01010776 | COMPLETED | Schizophrenia |
Janssen-Cilag Farmaceutica Ltda. |
2008-02 | PHASE4 |
| NCT00592358 | TERMINATED | Pediatric Bipolar Disorder |
Massachusetts General Hospital |
2007-11 | PHASE4 |
| NCT01724359 | COMPLETED | Schizophrenia |
Janssen-Cilag, S.A. |
2008-02 | PHASE4 |
| NCT00766064 | WITHDRAWN | Posttraumatic Stress Disorder |
Yale University |
2008-09 | PHASE4 |
| NCT01279213 | COMPLETED | Schizophrenia; Schizophrenic Disorders; Psychotic Disorder |
Universidad Nacional de Rosario |
2009-01 | PHASE4 |
| NCT01541371 | COMPLETED | Schizophrenia |
Xian-Janssen Pharmaceutical Ltd. |
2008-07 | PHASE3 |
| NCT00439634 | TERMINATED | Schizophrenia |
Sanofi |
2007-02 | PHASE2 |
| NCT00473434 | COMPLETED | Schizophrenia |
Janssen-Cilag Pty Ltd |
2007-04 | PHASE3 |
| NCT01150448 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-09 | PHASE1 |
| NCT01577186 | COMPLETED | Schizophrenia |
Johnson & Johnson Taiwan Ltd |
2008-07 | PHASE4 |
| NCT00589914 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-03 | PHASE3 |
| NCT00757705 | COMPLETED | Schizophrenia |
Johnson & Johnson Taiwan Ltd |
2008-03 | PHASE4 |
| NCT00645099 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2007-10 | PHASE3 |
| NCT01577160 | COMPLETED | Schizophrenia |
Johnson & Johnson Taiwan Ltd |
2008-05 | PHASE4 |
| NCT01094249 | COMPLETED | Schizophrenia; Bipolar Disorder; Psychotic Disorders |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2009-02 | PHASE1 |
| NCT00518323 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-08 | PHASE3 |
| NCT00535145 | COMPLETED | Schizophrenia; Schizoaffective Disorder; Psychotic Disorders |
Ortho-McNeil Janssen Scientific Affairs, LLC |
2007-10 | PHASE4 |
| NCT00460512 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2007-04-25 | PHASE3 |
| NCT00604279 | COMPLETED | Schizophrenia |
Xian-Janssen Pharmaceutical Ltd. |
2008-01 | PHASE3 |
| NCT01606228 | COMPLETED | Schizophrenia |
Janssen Pharmaceutica |
2007-12 | PHASE3 |
| NCT03730857 | COMPLETED | Schizophrenia |
Calo Psychiatric Center |
2008-01 | PHASE1 |
| NCT00524043 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-09 | PHASE4 |
| NCT01561898 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2006-06 | PHASE3 |
| NCT00535132 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-10 | PHASE4 |
| NCT07445217 | COMPLETED | Functional Outcomes |
Calo Psychiatric Center |
2008-03-10 | PHASE2 |
| NCT00412373 | COMPLETED | Schizoaffective Disorder; Psychotic Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-12 | PHASE3 |
| NCT00566631 | COMPLETED | Schizophrenia |
Janssen-Cilag International NV |
2007-07 | PHASE3 |
| NCT01662648 | COMPLETED | Schizophrenia |
Janssen Pharmaceutica |
2007-06 | PHASE3 |
| NCT01606254 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2007-01 | PHASE2 |
| NCT00590577 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-03 | PHASE3 |
| NCT00397033 | COMPLETED | Schizoaffective Disorder; Psychotic Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-11 | PHASE3 |
| NCT00396565 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2006-07 | PHASE3 |
| NCT00309699 | COMPLETED | Bipolar Disorder; Mood Disorders |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-04 | PHASE3 |
| NCT00299715 | COMPLETED | Bipolar Disorder; Mood Disorders |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-02 | PHASE3 |
| NCT00111189 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-02 | PHASE3 |
| NCT00668837 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-02 | PHASE3 |
| NCT00257023 | COMPLETED | Schizophrenia |
Janssen Pharmaceutical K.K. |
2005-02 | PHASE2 |
| NCT00645307 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-05 | PHASE3 |
| NCT00078039 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-03 | PHASE3 |
| NCT00210769 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-01 | PHASE3 |
| NCT00838669 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-08 | PHASE1 |
| NCT00791713 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-03 | PHASE1 |
| NCT00077714 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-01 | PHASE3 |
| NCT00791622 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-01 | PHASE1 |
| NCT00350467 | COMPLETED | Acute Schizophrenia |
Xian-Janssen Pharmaceutical Ltd. |
2006-06 | PHASE3 |
| NCT00791232 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-03 | PHASE1 |
| NCT00650793 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-03 | PHASE3 |
| NCT00334126 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-04 | PHASE3 |
| NCT00309686 | COMPLETED | Affective Psychosis, Bipolar; Bipolar Disorder; Mania |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-04 | PHASE3 |
| NCT00101634 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-12 | PHASE3 |
| NCT00105326 | COMPLETED | Schizophrenia; Insomnia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-02 | PHASE2 |
| NCT00083668 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-04 | PHASE3 |
| NCT01060228 | COMPLETED | Schizophrenia; Epilepsy |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2009-01 | PHASE1 |
| NCT00892541 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-10 | PHASE1 |
| NCT00791167 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-06 | PHASE1 |
| NCT00892125 | COMPLETED | Schizophrenia; Bipolar Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-09 | PHASE1 |
| NCT00791349 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-02 | PHASE1 |
| NCT00074477 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-10 | PHASE2 |
| NCT00892489 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-07 | PHASE1 |
| NCT00073320 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-08 | PHASE3 |
| NCT00796432 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-03 | PHASE1 |
| NCT00791284 | COMPLETED | Schizophrenia; Hepatic Impairment |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-08 | PHASE1 |
| NCT01110317 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-07 | PHASE1 |
| NCT00210548 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-04 | PHASE3 |
| NCT00086320 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-03 | PHASE3 |
| NCT00796471 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-06 | PHASE1 |
| NCT00210717 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-02 | PHASE3 |
| NCT00752427 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-06 | PHASE3 |
| NCT00119756 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2005-06 | PHASE3 |
| NCT00796081 | COMPLETED | Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-01 | PHASE1 |
| NCT00796029 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-07 | PHASE1 |
| NCT00791401 | COMPLETED | Schizophrenia; Renal Impairment |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-04 | PHASE1 |
| NCT00791193 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-03 | PHASE1 |
| NCT00758030 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-03 | PHASE1 |
| NCT00085748 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-08 | PHASE3 |
| NCT00796185 | COMPLETED | Schizophrenia; Schizoaffective Disorder |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-08 | PHASE1 |
| NCT00796276 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-05 | PHASE1 |
| NCT00892320 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-03 | PHASE1 |
| NCT00796640 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2003-09 | PHASE1 |
| NCT00790777 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2007-03 | PHASE1 |
| NCT00796835 | COMPLETED | Schizophrenia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-07 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-01)
Check the
Paliperidone
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.