ONDANSETRON HYDROCHLORIDE · Pfizer
Ondansetron hydrochloride is indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy (including cisplatin $\ge$ 50 mg/m²) and moderately emetogenic chemotherapy. It is also used to prevent nausea and vomiting in patients receiving radiotherapy (total body irradiation or radiation to the abdomen) and in patients during the postoperative period.
How ONDANSETRON HYDROCHLORIDE Works
Ondansetron is a selective 5-HT3 receptor antagonist. It works by blocking serotonin receptors located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. Cytotoxic chemotherapy triggers the release of serotonin from enterochromaffin cells in the small intestine, which stimulates vagal afferents via 5-HT3 receptors to initiate the vomiting reflex; ondansetron inhibits this pathway.
Details
- Status
- Prescription
- First Approved
- 1991-01-04
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET, SOLUTION
Companies
ONDANSETRON HYDROCHLORIDE Approval History
What ONDANSETRON HYDROCHLORIDE Treats
4 indicationsONDANSETRON HYDROCHLORIDE is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nausea and vomiting from highly emetogenic chemotherapy
- Nausea and vomiting from moderately emetogenic chemotherapy
- Nausea and vomiting from radiotherapy
- Postoperative nausea and vomiting
ONDANSETRON HYDROCHLORIDE Competitive Set
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03578081 results posted | A221602 NCI-2017-02410, UG1CA189823 | Ph 3 | completed | Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy |
| NCT01578265 | Ipca/ARL/127 | Ph 1 | completed | Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition |
| NCT01578252 | Ipca/ARL/126 | Ph 1 | completed | Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fasting Condition |
Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ONDANSETRON HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . initial and repeat courses of moderately emetogenic cancer chemotherapy. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vo...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.