NDAORALCAPSULE
Approved
Aug 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ALOXI (palonosetron hydrochloride) by Helsinn 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 2008.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALOXI (palonosetron HCl) 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 vomiting reflex. The drug is administered as an oral capsule with high binding affinity for 5-HT3 receptors and minimal affinity for other receptor types.
LOE Approaching
As ALOXI approaches loss of exclusivity, the brand team is likely consolidating and focusing on managed care and oncology partnerships to defend market position against generic entry.
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.