Last reviewed 2026-05-29 · How we verify

Paliperdidone ER

Janssen Korea, Ltd., Korea · FDA-approved active Small molecule ✓ Verified May 2026

Paliperdidone ER is a Atypical antipsychotic Small molecule drug developed by Janssen Korea, Ltd., Korea. It is currently FDA-approved for Schizophrenia, Schizoaffective disorder, Bipolar I disorder (acute and maintenance treatment).

Paliperidone ER is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain to reduce psychotic symptoms.

Paliperidone ER is a small molecule antipsychotic medication used to treat schizophrenia. It is administered in an extended-release form.

At a glance

Generic name	Paliperdidone ER
Sponsor	Janssen Korea, Ltd., Korea
Drug class	Atypical antipsychotic
Target	Dopamine D2 receptor, Serotonin 5-HT2A receptor
Modality	Small molecule
Therapeutic area	Psychiatry
Phase	FDA-approved

Mechanism of action

Paliperidone is the active metabolite of risperidone and works by antagonizing dopamine D2 receptors in mesolimbic and mesocortical pathways, which reduces positive symptoms of psychosis, while also blocking serotonin 5-HT2A receptors, which may enhance antipsychotic efficacy and reduce extrapyramidal side effects. The extended-release formulation provides sustained drug delivery over 24 hours, improving medication adherence and symptom control.

Approved indications

Schizophrenia
Schizoaffective disorder
Bipolar I disorder (acute and maintenance treatment)

Common side effects

Akathisia
Extrapyramidal symptoms
Weight gain
Prolactin elevation
Somnolence
Headache
Tachycardia

Key clinical trials

A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Paliperdidone ER CI brief — competitive landscape report
Paliperdidone ER updates RSS · CI watch RSS
Janssen Korea, Ltd., Korea portfolio CI

Frequently asked questions about Paliperdidone ER

What is Paliperdidone ER?

Paliperdidone ER is a Atypical antipsychotic drug developed by Janssen Korea, Ltd., Korea, indicated for Schizophrenia, Schizoaffective disorder, Bipolar I disorder (acute and maintenance treatment).

How does Paliperdidone ER work?

Paliperidone ER is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors in the brain to reduce psychotic symptoms.

What is Paliperdidone ER used for?

Paliperdidone ER is indicated for Schizophrenia, Schizoaffective disorder, Bipolar I disorder (acute and maintenance treatment).

Who makes Paliperdidone ER?

Paliperdidone ER is developed and marketed by Janssen Korea, Ltd., Korea (see full Janssen Korea, Ltd., Korea pipeline at /company/janssen-korea-ltd-korea).

What drug class is Paliperdidone ER in?

Paliperdidone ER belongs to the Atypical antipsychotic class. See all Atypical antipsychotic drugs at /class/atypical-antipsychotic.

What development phase is Paliperdidone ER in?

Paliperdidone ER is FDA-approved (marketed).

What are the side effects of Paliperdidone ER?

Common side effects of Paliperdidone ER include Akathisia, Extrapyramidal symptoms, Weight gain, Prolactin elevation, Somnolence, Headache.

What does Paliperdidone ER target?

Paliperdidone ER targets Dopamine D2 receptor, Serotonin 5-HT2A receptor and is a Atypical antipsychotic.

Drug class: All Atypical antipsychotic drugs
Target: All drugs targeting Dopamine D2 receptor, Serotonin 5-HT2A receptor
Manufacturer: Janssen Korea, Ltd., Korea — full pipeline
Therapeutic area: All drugs in Psychiatry
Indication: Drugs for Schizophrenia
Indication: Drugs for Schizoaffective disorder
Indication: Drugs for Bipolar I disorder (acute and maintenance treatment)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing