NDAINTRAVENOUSSOLUTION
Approved
Nov 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
3/8 — Basic
PALONOSETRON HYDROCHLORIDE (palonosetron hydrochloride) by Fresenius Kabi 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 2017.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Palonosetron hydrochloride is a 5-HT3 receptor antagonist administered intravenously to prevent nausea and vomiting associated with chemotherapy and postoperative settings. It works by blocking serotonin receptors on vagal nerve terminals and in the chemoreceptor trigger zone, preventing the cascade of neuronal events that trigger emesis. The drug is particularly effective in high-emetogenic chemotherapy regimens such as those using cisplatin.
Peak
Product is at peak lifecycle stage with moderate competitive pressure (30%), indicating stable but potentially challenged market positioning requiring defensive commercial strategies.
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 (4)
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
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Started Sep 2009
7 enrolled
Anal CancerCarcinoma of the AppendixColorectal Cancer+9 more
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Started Jun 2006
1,428 enrolled
Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific
Worked on PALONOSETRON HYDROCHLORIDE at Fresenius Kabi? Share your interview experience or compensation data (+7 days Pro)
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.