Wednesday, July 8, 2026

Drug profile · INN

ondansetron

ondansetron (APX-ONDANSETRON) is a serotonin 3a (5-ht3a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 6
Pipeline programs 27
News articles 0
Drug details — ondansetron
US status
approved
Class
Route
INJECTION
Patents
6
Programs
27
Data quality
0.89

Quick answer

ondansetron (APX-ONDANSETRON) is a serotonin 3a (5-ht3a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN ondansetron
Brand APX-ONDANSETRON
Mechanism Serotonin 3a (5-HT3a) receptor antagonist
Target 5-hydroxytryptamine receptor 3A
Route INJECTION
Formulation TABLET, ORALLY DISINTEGRATING

Mechanism of action

Serotonin 3a (5-HT3a) receptor antagonist

Primary target: 5-hydroxytryptamine receptor 3A

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. AD04 (ondansetron) Phase 3 · ADIAL PHARMACEUTICALS · Alcohol Use Disorder
  2. APHP220917 Phase 3 · PARItec · patient with colorectal cancer with hepatic metastasis
  3. DP-10027 Phase 3 · Anaxis Pharma · post-operative nausea and vomiting in pediatric patients
  4. IJB-SHAPERS-ODN-013 Phase 3 · George Institute for · locally advanced rectal cancer
  5. NEPA-22-01 Phase 3 · Biorex Healthcare Pvt · Chemotherapy-induced nausea and vomiting
  6. Ondansetron Phase 3 · United Therapeutics Europe · IBS - Irritable Bowel Syndrome
  7. XPORT-DLBCL-30 Phase 3 · Karyopharm Therapeutics · Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
  8. XPORT-MF-034 Phase 3 · Karyopharm Therapeutics · Treatment naïve patients with MF

Related & competitor drugs

  1. alosetron hydrochloride Serotonin 3a (5-HT3a) receptor antagonist
  2. granisetron Alimentary tract and metabolism (A04)
  3. granisetron hydrochloride Serotonin 3a (5-HT3a) receptor antagonist
  4. ondansetron hydrochloride Serotonin 3a (5-HT3a) receptor antagonist
  5. palonosetron hydrochloride Serotonin 3a (5-HT3a) receptor antagonist
  6. dolasetron mesylate Serotonin 3a (5-HT3a) receptor antagonist
  1. US 11273131

    Pharmaceutical compositions with enhanced permeation

    Expires Mon Mar 10 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11129799

    Dual lane coating

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 10947033

    Reduction in stress cracking of films

    Expires Mon Mar 11 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 10464739

    Reduction in stress cracking of films

    Expires Mon Oct 31 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10034833

    Sublingual and buccal film compositions

    Expires Mon Jul 26 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 9675588

    Ondansetron extended release solid dosage forms for treating either nausea, vomiting or diarrhea symptoms

    Expires Mon Jun 08 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ondansetron?

ondansetron (APX-ONDANSETRON) is a serotonin 3a (5-ht3a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for ondansetron?

APX-ONDANSETRON is a marketed brand name for ondansetron. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ondansetron?

ondansetron 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.