Netupitant

Overview

Netupitant is an antiemitic drug approved by the FDA in October 2014 for use in combination with palonosetron for the prevention of acute and delayed vomiting and nausea associated with cancer chemotherapy including highly emetogenic chemotherapy. Netupitant is a neurokinin 1 receptor antagonist. The combination drug is marketed by Eisai Inc. and Helsinn Therapeutics (U.S.) Inc. under the brand Akynzeo.

Indication

用于治疗和预防化疗引起的急性和延迟性恶心、呕吐。

Associated Conditions

Acute chemotherapy-induced nausea and vomiting
Delayed chemotherapy-induced nausea and vomiting

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens	2024/03/26	NCT06331520	Phase 3	Not yet recruiting	Fudan University
Efficacy of Olanzapine, Netupitant and Palonosetron in Controlling Nausea and Vomiting Associated With Highly Emetogenic Chemotherapy in Patients With Breast Cancer	2020/12/16	NCT04669132	Phase 2	Completed	Instituto Brasileiro de Controle do Cancer
PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting	2017/07/02	NCT03204279	Phase 2	Completed	Helsinn Healthcare SA
Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant	2017/03/31	NCT03097588	Phase 2	Completed	OHSU Knight Cancer Institute
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer	2017/02/02	NCT03040726	Phase 2	Completed	M.D. Anderson Cancer Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
AKYNZEO	Helsinn Therapeutics (U.S.), Inc.	69639-101	ORAL	300 mg in 1 1	2/10/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Akynzeo	Helsinn Birex Pharmaceuticals Ltd,Damastown,Mulhuddart,15 Dublin,Ireland	Authorised	5/27/2015

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AKYNZEO CAPSULES 300MG/0.5MG	Helsinn Birex Pharmaceuticals Ltd. (Intermediate Netupitant Tablets and final drug product), CATALENT PHARMA SOLUTIONS LLC (Intermediate Palonosetron softgels)	SIN15031P	CAPSULE, GELATIN COATED	300mg	6/8/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
AKYNZEO CAPSULES 300MG/0.5MG	N/A	FOSUN INDUSTRIAL CO., LIMITED	N/A	N/A	7/31/2017

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AKYNZEO netupitant/palonosetron (as hydrochloride) 300 mg/500 mcg capsule blister pack	222237	Juniper Biologics Pty Ltd	Medicine	A	5/6/2015

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AKYNZEO	knight therapeutics inc.	02468735	Capsule - Oral	300 MG	11/20/2017

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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