Back to discover
Drug

Palonosetron

Established medicine
ResearchOngoing clinical research
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.

RxNorm70561ChEMBLCHEMBL1189679UNII5D06587D6R
3
Active clinical trials
5
Regulatory events
Latest activity
beta

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

Label change: PALONOSETRON (ANDA206801)

Regulatory2026-09-21FDA

Label change: PALONOSETRON (ANDA206802)

Regulatory2026-09-21FDA

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

Clinical trial2026-08-20Status changed to Completed · 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

Reduced/No Dexamethasone With Netupitant/Palonosetron and Olanzapine for Chemotherapy‑Induced Nausea/Vomiting in Highly Emetogenic Chemotherapy: Phase III Noninferiority Trial

Clinical trial2026-06-04Trial news · Journal of Clinical Oncology

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

Generic approval: PALONOSETRON (ANDA206801)

Regulatory2018-09-19FDA

Generic approval: PALONOSETRON (ANDA206802)

Regulatory2018-09-19FDA

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
fdaema

Regulatory timeline

5 events

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 on record (generic/biosimilar)
2016-05-26
Latest approval
2018-09-19
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-09-21Label change
Label change: PALONOSETRON (ANDA206801)
Evidence ↗
2026-09-21Label change
Label change: PALONOSETRON (ANDA206802)
Evidence ↗
2018-09-19Generic approvalMarket
Generic approval: PALONOSETRON (ANDA206801)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2016-05-26Generic approvalMarket
Generic medicine authorisation: 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 ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

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

Clinical trials

65 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
65
registered trials across all phases
LATEST COMPLETION 2026
3
Active studies
2
Recruiting
45
Late-stage (III+)
50
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 65
Phase 11Phase 1 / 22Phase 217Phase 2 / 32Phase 316Phase 415Phase N / A12

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Not yet recruitingPH IVKey trialSecond Affiliated Hospital, School of Medicine, Zhejiang Universityn=1,0282029

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

Not yet recruitingPH IVShanghai General Hospital, Shanghai Jiao Tong University School of Medicinen=842027

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

CompletedPH IVUniversity of Malayan=742026

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

CompletedPH IVUniversity of Malayan=922024

Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study

Unknown statusPH IVTheodor Bilharz Research Instituten=902021

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IVUniversity of Malayan=742026

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

CompletedPH IVUniversity of Malayan=922024

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

CompletedPH II/IIIM.D. Anderson Cancer Centern=532022

Effect of Palonosetron on Effect-site Concentration of Remifentanil for Preventing Emergence Cough During General Anesthesia in Female Patients Undergoing Laparoscopic Cholecystectomy

CompletedN/AAjou University School of Medicinen=452021

A Randomized, Single-dose, Two-way Crossover Study to Evaluate Bioequivalence of Two Formulations of Palonosetron After Intravenous Administration of Palonosetron in Healthy Volunteers Under Fasting Conditions

CompletedPH IVYung Shin Pharm. Ind. Co., Ltd.n=162020

Efficacy of Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Nondrinking Women Younger Than 50 Years Who Received Moderately Emetogenic Chemotherapy: A Randomized, Double-blind, Phase Ⅲ Trial

CompletedPH IIISun Yat-sen Universityn=2482020
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.