Last reviewed 2026-06-02 · How we verify

Ondansetron (ODT)

Ondansetron (ODT) is a 5-HT3 receptor antagonist Small molecule drug developed by MonoSol Rx. It is currently FDA-approved for Prevention of nausea and vomiting induced by chemotherapy, Prevention of nausea and vomiting induced by radiotherapy, Prevention of post-operative nausea and vomiting. Also known as: Zofran.

Ondansetron blocks serotonin (5-HT3) receptors on chemoreceptor trigger zone and vagal afferent nerves to prevent nausea and vomiting.

Ondansetron (ODT) is a small molecule medication used to treat various conditions, including solid tumors, lymphoma, concussion post syndrome, and acute gastroenteritis, as indicated by ClinicalTrials.gov. It is available in the form of orally disintegrating tablets, as seen in studies such as NCT00934921, which investigated its bioavailability under non-fasting conditions.

At a glance

Mechanism of action

Ondansetron is a selective 5-HT3 receptor antagonist that inhibits serotonin signaling in the chemoreceptor trigger zone and gastrointestinal tract. By blocking these receptors, it prevents the emetic signals that trigger nausea and vomiting, particularly those induced by chemotherapy, radiation, or post-operative conditions. The ODT (orally disintegrating tablet) formulation allows rapid dissolution on the tongue for convenient administration.

Approved indications

• Prevention of nausea and vomiting induced by chemotherapy
• Prevention of nausea and vomiting induced by radiotherapy
• Prevention of post-operative nausea and vomiting

Common side effects

• Headache
• Constipation
• Diarrhea
• Fatigue
• Dizziness

Key clinical trials

• A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obesity (PHASE1)
• T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers (PHASE1)
• Inhaled Isopropyl Alcohol for Treatment of Nausea (PHASE2, PHASE3)
• Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma (PHASE2)
• Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas (PHASE1)
• A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents (EARLY_PHASE1)
• Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions (PHASE1)
• Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions (PHASE1)

Primary sources

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

Competitive intelligence

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

• Ondansetron (ODT) CI brief — competitive landscape report
• Ondansetron (ODT) updates RSS · CI watch RSS
• MonoSol Rx portfolio CI

Frequently asked questions about Ondansetron (ODT)

Related

• Drug class: All 5-HT3 receptor antagonist drugs
• Target: All drugs targeting 5-HT3 receptor
• Manufacturer: MonoSol Rx — full pipeline
• Therapeutic area: All drugs in Oncology, Gastroenterology
• Indication: Drugs for Prevention of nausea and vomiting induced by chemotherapy
• Indication: Drugs for Prevention of nausea and vomiting induced by radiotherapy
• Indication: Drugs for Prevention of post-operative nausea and vomiting
• Also known as: Zofran

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