NDAINTRAVENOUSSOLUTION
Approved
Aug 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
PALONOSETRON HYDROCHLORIDE (palonosetron hydrochloride) by Hikma is 5-ht 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Approved for chemotherapy-induced nausea and vomiting, nausea and vomiting. First approved in 2016.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Palonosetron hydrochloride is a selective 5-HT3 receptor antagonist indicated for chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting. It works by blocking serotonin receptors on vagal nerve terminals and in the chemoreceptor trigger zone, preventing the cascade of neuronal events that trigger the emetic response. Administered intravenously as a solution, it is a first-line antiemetic for high-emetogenic chemotherapy regimens.
Peak
Product is in peak revenue stage as a mature antiemetic with established market position; brand teams focus on market share defense and clinical value differentiation.
Mechanism of Action
5-HT 3 receptor antagonist with a strong binding affinity for this receptor and little or no affinity for other receptors. Cancer chemotherapy may be associated with a high incidence of nausea and vomiting, particularly when certain agents, such as cisplatin, are used. 5-HT 3 receptors are located…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.