PALONOSETRON HYDROCHLORIDE

Post-LOE

palonosetron

Fresenius Kabi

ANDAINTRAVENOUSINJECTABLE

Approved

Sep 2018

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

PALONOSETRON HYDROCHLORIDE (palonosetron) 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. Approved for delayed nausea, vomiting associated with initial, repeat courses of moderately emetogenic cancer chemotherapy (mec) and 2 more indications. First approved in 2018.

Drug data last refreshed 20h ago

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 (5)

delayed nausea vomiting associated with initial

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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.

Clinical Trials (20)

NCT06904235Phase 2Recruiting

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

NCT03403712Phase 3Completed

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

NCT03204279Phase 2Completed

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)

NCT03040726Phase 2/3Completed

Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

Started May 2017

53 enrolled

Malignant NeoplasmNauseaVomiting

NCT03097588Phase 2Completed

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