NDAORALCAPSULE
Approved
Aug 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
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. First approved in 2008.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALOXI (palonosetron HCl) is a highly selective 5-HT3 receptor antagonist approved for prevention of nausea and vomiting in patients receiving chemotherapy or undergoing surgery. It works by blocking serotonin receptors on vagal nerve terminals and in the chemoreceptor trigger zone, preventing the emetic cascade triggered by chemotherapy agents like cisplatin or intraoperative serotonin release.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting defensive positioning and potential team restructuring.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Started Jun 2025
600 enrolled
Breast Cancer
Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.
Started Jan 2021
61 enrolled
SARS CoV 2 Infection
An Observational Study Assessing Effects in Patients With Combination Therapy With Raloxifene/Cholecalciferol
Started Nov 2017
3,907 enrolled
Osteoporosis
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Started May 2017
53 enrolled
Malignant NeoplasmNauseaVomiting
Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant
Started Apr 2017
43 enrolled
Malignant Neoplasm
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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.