Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

risperidone

APO-RISPERIDONE

risperidone (APO-RISPERIDONE) is a serotonin 2c (5-ht2c) receptor antagonist. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: intramuscular. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Nervous system (N05) N05AX08
US status approved
Patents linked 14
Pipeline programs 12
News articles 0
Drug details — risperidone
US status
approved
Class
Nervous system (N05)
Route
INTRAMUSCULAR
Patents
14
Programs
12
Data quality
0.89
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Quick answer

risperidone (APO-RISPERIDONE) is a serotonin 2c (5-ht2c) receptor antagonist. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: intramuscular. Current US regulatory status: approved.

Key facts

INN risperidone
Brand APO-RISPERIDONE
Mechanism Serotonin 2c (5-HT2c) receptor antagonist
Target D(2) dopamine receptor
Therapeutic class Nervous system (N05)
Route INTRAMUSCULAR
Formulation TABLET, ORALLY DISINTEGRATING
ATC code N05AX08
Originator Servier Laboratories (Aust.) Pty.

Mechanism of action

Serotonin 2c (5-HT2c) receptor antagonist

Primary target: D(2) dopamine receptor

Approval history

Authority Status Date
FDA approved —
EMA approved —
TGA approved —
PMDA approved —
NMPA clinical trials —

Pipeline programs

Search pipeline Sponsor programs
  1. Risperidone Phase 2 · Indivior Pty · Schizophrenia
  2. Risperidone Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine-Related Disorders
  3. Sertraline combined with Lactobacillus crispatus Phase 2 · First People's Hospital · Major Depressive Disorder (MDD)
  4. risperidone Phase 2 · Ultragenyx UK · Tourette Syndrome
  5. Risperidone Phase 1 · CORCEPT THERAPEUTICS · Healthy
  6. Risperidone Phase 1 · First People's Hospital · Schizophrenia
  7. Risperidone Phase 1 · Teva Pharma · Healthy
  8. ARIPIPRAZOLE , RISPERIDONE Approved · Disc Medicine · Autism spectrum disorder

Related & competitor drugs

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  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

Related patents

Browse patents Servier Laboratories (Aust.) Pty. patent hub

  1. US 11712475

    Sustained delivery formulations of risperidone compound

    Expires Mon Jul 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 11110093

    Sustained release small molecule drug formulation

    Expires Mon Sep 02 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 11013809

    Sustained delivery formulations of risperidone compound

    Expires Mon May 20 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 10406160

    Sustained release small molecule drug formulation

    Expires Mon Sep 05 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 10376590

    Sustained delivery formulations of risperidone compound

    Expires Mon Aug 08 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 10058554

    Sustained release small molecule drug formulation

    Expires Mon Aug 23 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 10010612

    Sustained delivery formulations of risperidone compounds

    Expires Mon Jun 28 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 9186413

    Sustained delivery formulations of risperidone compounds

    Expires Mon Nov 12 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 9180197

    Sustained delivery formulations of risperidone compounds

    Expires Mon Nov 05 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 9107832

    Risperidone microparticles formed by sublimation

    Expires Mon Aug 13 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 9050343

    Combination of pimavanserin and risperidone for the treatment of psychosis

    Expires Mon Jun 04 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. 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

  13. US 7256195

    Preparation of risperidone

    Expires Mon Aug 09 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 6750341

    Preparation of risperidone

    Expires Mon Jun 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is risperidone?

risperidone (APO-RISPERIDONE) is a serotonin 2c (5-ht2c) receptor antagonist. Associated with Servier Laboratories (Aust.) Pty.. Route of administration: intramuscular. Current US regulatory status: approved.

What is the brand name for risperidone?

APO-RISPERIDONE is a marketed brand name for risperidone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of risperidone?

risperidone 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.

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