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Drug

Paliperidone

Established medicine
ClassSerotonin 2a (5-HT2a) receptor antagonistResearchOngoing clinical research

Also known as 9-hydroxyrisperidone, Erzofri, Invega, Paliperidona.

RxNorm679314ChEMBLCHEMBL1621ATCN05AX13UNII838F01T721
1
Active clinical trials
2
Protein targets
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"

Clinical trial2026-04-13Results expected Q3 2027 · ClinicalTrials.gov

Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis

Clinical trial2025-06-01Primary completion · ClinicalTrials.gov

Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study

Clinical trial2025-05-31Completed · ClinicalTrials.gov

Label change: PALIPERIDONE (ANDA218514)

Regulatory2025-03-27FDA

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group 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

Clinical trial2024-11-12Results posted · ClinicalTrials.gov

Approval: PALIPERIDONE (ANDA218514)

Regulatory2024-06-26FDA

European Long-acting Antipsychotics in Schizophrenia Trial

Clinical trial2020-08-26Completed · ClinicalTrials.gov

Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route

Clinical trial2019-05-02Completed · ClinicalTrials.gov

Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE)

Clinical trial2018-07-10Results posted · ClinicalTrials.gov

A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia

Clinical trial2017-09-30Completed · ClinicalTrials.gov

Pharmacovigilance in Gerontopsychiatric Patients

Clinical trial2017-06-28Terminated · ClinicalTrials.gov

Approval: Invega (EMA)

Regulatory2007-06-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Paliperidone
Aliases & brands
9-hydroxyrisperidoneErzofriInvegaPaliperidona
RxNorm CUI
679314
ChEMBL ID
CHEMBL1621
ATC codes
N05AX13
UNII
838F01T721
Primary mechanism
Serotonin 2a (5-HT2a) receptor antagonist
Regulatory jurisdictions
fdaema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

5-hydroxytryptamine receptor 2A
HTR2A · P28223
ANTAGONISTSerotonin 2a (5-HT2a) receptor antagonist
D(2) dopamine receptor
DRD2 · P14416
ANTAGONISTDopamine D2 receptor antagonist

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-06-24
Latest approval
2024-06-26
Authorities
FDA · EMA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2025-03-27Label change
Label change: PALIPERIDONE (ANDA218514)
Evidence ↗
2024-06-26Approval
Approval: PALIPERIDONE (ANDA218514)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2007-06-24Approval
Approval: Invega (EMA)

Indication: Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. Invega is indicated for the treatment of schizoaffective disorder in adults.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

34 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
34
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
26
Late-stage (III+)
25
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 34
Phase 13Phase 1 / 21Phase 24Phase 2 / 31Phase 35Phase 417Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

"Re-examining Maintenance Antipsychotic Treatment in Schizophrenia: "Extended" Antipsychotic Dosing"

RecruitingPH IVCentre for Addiction and Mental Healthn=1202028

Open-label, Multicenter, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Aripiprazole vs Paliperidone/Risperidone Using Multi-omics Data in Patients With a First Episode Psychosis

Unknown statusPH IVConsorcio Centro de Investigación Biomédica en Red (CIBER)n=2442025

European Long-acting Antipsychotics in Schizophrenia Trial

CompletedPH IVUMC Utrechtn=5362020

Effectiveness of Paliperidone ER(Invega®) on Depressive Symptoms of Schizophrenia Patients: A 8-week Open-label Prospective, Non-comparative Study

CompletedPH IVSeoul National University Hospitaln=112016

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial

CompletedPH IVTechnical University of Munichn=212016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Substance Misuse To Psychosis for Stimulants (SToP-S)--An Early Assertive Pharmacotherapy Intervention Study

CompletedPH II/IIIThe University of Hong Kongn=1652025

European Long-acting Antipsychotics in Schizophrenia Trial

CompletedPH IVUMC Utrechtn=5362020

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group 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

CompletedPH IIAstellas Pharma Global Development, Inc.n=2332019

Α Randomized, Two-way, Two-treatment, Two-period, Crossover, Open Label, Laboratory-blind, Comparative Bioavailability Study at Steady State Between Paliperidone 100 mg Prolonged Release Suspension for Injection (Test Product) and Xeplion® 100 mg Prolonged Release Suspension for Injection (Reference Product) Following Multiple Intramuscular Injections (Five Doses in Each Period, One Dose Every 28 Days) Administration to Patients With Schizophrenia Who Are Already Receiving a Stable Regimen of Paliperidone Prolonged Release Suspension Via The Intramuscular Route

CompletedPH I/IIPharmathen S.A.n=702019

A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia

CompletedN/ABeijing HuiLongGuan Hospitaln=1002017

Whole Blood and Plasma Sample Collection for the Development of Antipsychotic Immunoassays From Participants Taking Aripiprazole, Olanzapine, Paliperidone, or Risperidone

CompletedPH IJanssen Research & Development, LLCn=812016
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.