Drug

Palonosetron

Approved · EMA

Late-stage development

Also known as Akynzeo, Aloxi, Posfrea, 2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one+2 more

Akynzeo, Aloxi, Posfrea, 2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-one, Palonosetron Hydrochloride, Palonosetronum.

RxNorm70561 ChEMBLCHEMBL1189679UNII5D06587D6R

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Comparison Between Palonosetron Versus Granisetron As Postoperative Nausea and Vomiting Prophylaxis In Idiopathic Scoliosis Surgery: A Randomized Control Trial

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial

Clinical trial2026-06-10Results expected Q1 2027 · ClinicalTrials.gov

Drug Disposition and Nephrotoxicity

Clinical trial2025-08-11Results expected Q3 2027 · ClinicalTrials.gov

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation (Carboplatin and Taxol) as First Line Treatment for Patients With Local Regional Advanced Gastric Cancer

Clinical trial2025-08-01Primary completion · ClinicalTrials.gov

A Multicenter Multinational Randomized Double Blind PK/PD Dose-finding Study of Oral Netupitant Given With Oral Palonosetron in Pediatric Cancer Patients for Prevention of Nausea and Vomiting Associated With Emetogenic Chemotherapy

Clinical trial2024-06-25Results posted · ClinicalTrials.gov

A Comparison Between Palonosetron And Ondansetron As Prophylaxis Against Postoperative Nausea and Vomiting In Idiopathic Scoliosis Surgery: A Randomised Trial

Clinical trial2024-05-02Completed · ClinicalTrials.gov

Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients

Clinical trial2023-10-17Results posted · ClinicalTrials.gov

Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy

Clinical trial2023-09-01Primary completion · ClinicalTrials.gov

Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of Breast Cancer Chemotherapy-induced Nausea and Vomiting: a Single-center, Randomized Controlled Clinical Trial

Clinical trial2023-05-03Results expected Q3 2028 · ClinicalTrials.gov

Granisetron Transdermal Delivery System Versus Palonosetron in the Prevention of Delayed Chemotherapy-induced Nausea and Vomiting: a Phase 3 Non-inferiority Randomized Trial

Clinical trial2022-06-10Primary completion · ClinicalTrials.gov

Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.

Clinical trial2022-03-01Withdrawn · ClinicalTrials.gov

Approval: Palonosetron Accord (EMA)

Regulatory2016-05-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Palonosetron

Aliases & brands

AkynzeoAloxiPosfrea2-(1-Azabicyclo(2.2.2)oct-3-yl)-2,3,3a,4,5,6-hexahydro-1H-benz(de)isoquinolin-1-onePalonosetron HydrochloridePalonosetronum

RxNorm CUI

70561

ChEMBL ID

CHEMBL1189679

UNII

5D06587D6R

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2016-05-26

Latest approval

2016-05-26

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2016-05-26Approval

Approval: Palonosetron Accord (EMA)

Indication: Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and… Show full indication

Palonosetron Accord is indicated in adults for: the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for: The prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.