Wednesday, July 8, 2026

Drug profile · INN

amisulpride

amisulpride (AMISULPRIDE SANDOZ PHARMA) is a serotonin (5-ht) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — amisulpride
US status
approved
Class
Route
INTRAVENOUS
Patents
0
Programs
9
Data quality
0.84

Quick answer

amisulpride (AMISULPRIDE SANDOZ PHARMA) is a serotonin (5-ht) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN amisulpride
Brand AMISULPRIDE SANDOZ PHARMA
Mechanism Serotonin (5-HT) receptor antagonist
Target Dopamine receptors; D2 & D3
Route INTRAVENOUS
Formulation SOLUTION

Mechanism of action

Serotonin (5-HT) receptor antagonist

Primary target: Dopamine receptors; D2 & D3

Approval history

Authority Status Date
FDA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. DP-10027 Phase 3 · Anaxis Pharma · post-operative nausea and vomiting in pediatric patients
  2. 400 U EV71 vaccine with adjuvant Phase 2 · Sinovac Research and · Infection, Viral, Enterovirus
  3. 400 microgrammes GSK961081 Phase 2 · Theravance Biopharma Ireland · Pulmonary Disease, Chronic Obstructive
  4. 400 µg of MBX 2109 once-weekly by subcutaneous injection Phase 2 · MBX Biosciences · Hypoparathyroidism
  5. 200 mg GLPG0634 as capsules, fasted Phase 1 · Lakefront Biotherapeutics NV · Healthy
  6. 400 mg Cannabidiol Phase 1 · BRIGHT MINDS BIOSCIENCES · Chronic Pain
  7. 400 mg LX4211 Phase 1 · LEXICON PHARMACEUTICALS · Type 2 Diabetes Mellitus
  8. INTENSIFY SZ Approved · Disc Medicine · schizophrenia, schizoaffective disorder, schizophrenifom dis

Frequently asked questions

What is amisulpride?

amisulpride (AMISULPRIDE SANDOZ PHARMA) is a serotonin (5-ht) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for amisulpride?

AMISULPRIDE SANDOZ PHARMA is a marketed brand name for amisulpride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of amisulpride?

amisulpride 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.