NDAINTRAVENOUSSOLUTION
Approved
Mar 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
POSFREA (palonosetron) by Viatris (2) 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 2016.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
POSFREA (palonosetron) is a selective 5-HT3 receptor antagonist indicated for prevention of chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). It works by blocking serotonin activation of vagal afferents and chemoreceptor trigger zone receptors that trigger the emetic cascade. The drug is administered intravenously as a solution.
Peak
Product is at peak commercial maturity under Viatris ownership with moderate competitive pressure (30 relative score), indicating established market position but faces ongoing generic/competitor erosion.
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)
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Started Jul 2025
95 enrolled
Nausea and Vomiting Chemotherapy-InducedNausea Post Chemotherapy
A Study to Assess the Safety and the Efficacy of IV Fosnetupitant/Palonosetron (260 mg/0.25 mg) Combination Compared to Oral Netupitant/Palonosetron (300 mg/0.5 mg) Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
Started Mar 2018
404 enrolled
Chemotherapy-induced Nausea and Vomiting
PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
Started Aug 2017
67 enrolled
Chemotherapy-induced Nausea and Vomiting (CINV)
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.