Wednesday, July 8, 2026

Drug profile · INN

paliperidone

paliperidone (INVEGA) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N05) N05AX13
US status approved
Patents linked 1
Pipeline programs 5
News articles 0
Drug details — paliperidone
US status
approved
Class
Nervous system (N05)
Route
ORAL
Patents
1
Programs
5
Data quality
0.89

Quick answer

paliperidone (INVEGA) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN paliperidone
Brand INVEGA
Mechanism Serotonin 2a (5-HT2a) receptor antagonist
Target D(2) dopamine receptor
Therapeutic class Nervous system (N05)
Route ORAL
Formulation TABLET, EXTENDED RELEASE
ATC code N05AX13

Mechanism of action

Serotonin 2a (5-HT2a) receptor antagonist

Primary target: D(2) dopamine receptor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Paliperidone palmitate Phase 3 · Janssen Cilag International · Schizophrenia
  2. LY03010/CT-EUR-102 Phase 1 · Anaxis Pharma · Schizophrenia
  3. INTENSIFY SZ Approved · Disc Medicine · schizophrenia, schizoaffective disorder, schizophrenifom dis
  4. NL6220204217 Approved · Disc Medicine · HAMLETT compares regular treatment guidelines for patients i
  5. Paliperidone ER Approved · Hospital Authority · Schizophrenia

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. cabergoline Dopamine D2 receptor agonist
  1. US 7915412

    Process for the synthesis of 9-hydroxy risperidone (paliperidone)

    Expires Mon Mar 24 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is paliperidone?

paliperidone (INVEGA) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Janssen-Cilag Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for paliperidone?

INVEGA is a marketed brand name for paliperidone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of paliperidone?

paliperidone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.