drug
as of 2026-07-01Paliperidone
Paliperidone palmitatepaliperidoneextended-release (ER) OROS paliperidonepaliperidone ER OrosPaliperidone PalmitatePaliperidone ERpaliperidone ERPaliperidone palmitate Treatment A
MeSH D000068882UNII 838F01T721RxCUI 672567, 672569, 672571, 686441, 686443, 686445FDA_ApplNo NDA021999SPL_set_id 492bf9dd-868e-421a-92db-8cca8973aac1FDA_sponsor JANSSEN PHARMSOrangeBook_Appl A202645, A203279, A203802, A204452, A204707, A205402, A205559, A205618
at a glance
small molecule · Atypical Antipsychotic [EPC]
US-approved (2006) as Erzofri extended-release
Developed by Johnson & Johnson
Orange Book protection to 2041
149 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
FDA class
Atypical Antipsychotic [EPC]
Mechanism of action
12.1 Mechanism of Action Paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3) ] . Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in the listed indications is unclear. However, the drug's effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2) and serotonin Type 2 (5HT 2A ) receptor antagonism.
Indications
Labeled
Schizophrenia
Investigational (via trials)
Patents & exclusivity
Orange Book
patent 11666697 · U-36262041-11-24
patent 11304951 · U-33492041-05-07
patent 12208100 · U-33592041-05-07
patent 11324751 · U-33592041-05-07
patent 11666573 · U-39682039-09-24
patent 12128049 · U-39682038-10-26
patent 10143693 · U-24572036-04-05
patent 9439906 · U-27582031-01-26
Adverse-event signal
FAERS spontaneous · within-drug share
Prolactin11.3%
top term: GYNAECOMASTIA
Weight Metabolic7.3%
top term: WEIGHT INCREASED
Eps Akathisia7.1%
top term: TREMOR
Sedation3.4%
top term: SEDATION
Mortality2.3%
top term: SUICIDE ATTEMPT
Gi1.5%
top term: NAUSEA
Anticholinergic0.9%
top term: CONSTIPATION
Nms0.6%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Qt Cardiac0.6%
top term: TACHYCARDIA
Orthostatic0.4%
top term: HYPOTENSION
Spontaneous reports — a signal of reporting share, not incidence.
Trials
149
"Extended" (Alternate Day) Antipsychotic Dosing
NCT04478838Phase 4Recruiting
A Bioequivalence Study of PP3M in Patients With Schizophrenia
NCT07493551—Recruiting
Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia
NCT07075237Phase 4Not Yet Recruiting
Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study
NCT07153835Phase 4Not Yet Recruiting
Multidisciplinary Design to Optimize Schizophrenia Treatment Based on Multi-omics Data and Systems Biology Analysis
NCT06060886Phase 4Unknown
Bioequivalence Study of Long-Acting Paliperidone Palmitate in Patients With Schizophrenia
NCT07268430—Completed
Substance Misuse To Psychosis for Stimulants
NCT03485417Phase 2, Phase 3Completed
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
NCT04940039Phase 4Completed
Relative Bioavailability of LY03010 Compared to Listed Drug
NCT04922593Phase 1Completed
Oral Risperidone Versus Injectable Paliperidone Palmitate for Treating First-Episode Schizophrenia
NCT01451736Phase 4Completed
The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk
NCT04064476—Unknown
A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal
NCT03666715—Completed
European Long-acting Antipsychotics in Schizophrenia Trial
NCT02146547Phase 4Completed
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
NCT04572685Phase 1Completed
A Study to Evaluate the Ability of Conducting a Study of Oral Risperidone Followed by Paliperidone Palmitate in Rwandan Healthcare Facilities
NCT03713658Phase 4Completed
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
NCT02431702Phase 3Completed
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
NCT03557931Phase 2Completed
A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
NCT03751488Phase 1Completed
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
NCT03809325—Completed
A Clinical Study to Evaluate the Bioavailability Between Two Products Containing Paliperidone 100 mg in the Form of a Prolonged Release Suspension for Injection in Patients With Schizophrenia Who Are Already Stabilized in This Treatment
NCT03425552Phase 1, Phase 2Completed
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
NCT03345979Phase 3Completed
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia
NCT04076371—Completed
Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection
NCT03390712—Unknown
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
KOLs & investigators
12
Stefan Leucht, ProfessorKOL score 87
Gary Remington, MD PhD FRCPCKOL score 12
Michael Davidson, professorKOL score 11
Wolfgang Fleischhacker, professorKOL score 8
Keith H Nuechterlein, Ph.D.KOL score 5
Scott Stroup, MD, MPHKOL score 5
Helge Frieling, Prof., MDKOL score 5
Xiang Y Zhang, MD,PhDKOL score 5
Gang Wang, M.D.KOL score 5
Steven M Silverstein, Ph.D.KOL score 5
Joseph P. McEvoy, MDKOL score 4
Rene S Kahn, professorKOL score 2
Facts & assertions
28 sourced
Anda Generic Count
58
Boxed Warning
present
Dosing Frequency
once daily
Faers Share Anticholinergic
0.009
Faers Share Eps Akathisia
0.071
Faers Share Gi
0.015
Faers Share Mortality
0.023
Faers Share Nms
0.006
Faers Share Orthostatic
0.004
Faers Share Prolactin
0.113
Faers Share Qt Cardiac
0.006
Faers Share Sedation
0.034
Faers Share Weight Metabolic
0.074
Fda Pharm Class Epc
Atypical Antipsychotic [EPC]
Has Generic Competition
yes
Latest Patent Expiry
2041-11-24
Latest Protection Date
2041-11-24
Mechanism Of Action
12.1 Mechanism of Action Paliperidone palmitate is hydrolyzed to paliperidone [see Clinical Pharmacology (12.3) ] . Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in the listed indications is unclear. However, the drug's effect in schizophrenia co
Originator Company
Janssen Pharms
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Safety Weight Metabolic
present in label
Us Approved
yes
Us Original Approval Date
2006-12-19
relationships
The graph out of here
developer
company
trial
indication
indication
indication
indication
indication
KOL
Stefan Leucht, Professor
personKOL score 87
Gary Remington, MD PhD FRCPC
personKOL score 12
Michael Davidson, professor
personKOL score 11
Wolfgang Fleischhacker, professor
personKOL score 8