Aloxi

(Palonosetron)

ApprovedSmall molecule

Palonosetron is used to prevent nausea and vomiting caused by chemotherapy or surgery. It works by blocking signals in the brain that trigger the urge to vomit.[2] Aloxi is currently approved and in use across 16 indications[4].[1]

Aloxi is one of 304 small molecule programs targeting Post Operative Nausea and Vomiting. It is currently in Approved.

Indications

Total Trials

Active Trials

303

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Post Operative Nausea and VomitingCompleted

Brain CancerApproved

Idiopathic ScoliosisCompleted

Breast NeoplasmApproved

Malignant GliomaApproved

StrabismusApproved

Breast CancerNot yet recruiting

MelanomaApproved

Multiple MyelomaApproved

DexamethasoneUnknown status

Post Operative Nausea and VomitingApproved

Completed

Brain CancerApproved

Approved

Idiopathic ScoliosisApproved

Completed

Breast NeoplasmApproved

Approved

Malignant GliomaApproved

Approved

StrabismusApproved

Approved

Breast CancerApproved

Not yet recruiting

MelanomaApproved

Approved

Multiple MyelomaApproved

Approved

DexamethasonePreclinical

Unknown status

Showing 10 of 13 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Aloxi

AAvyxa

Approved

2 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Voltaren

Novartis

Preclinical

1 5

Zolymbus

AbbVie

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 3Active, not recruiting

Nephrotoxicity

NCT03817970

Q3 2029

Post-ApprovalNot yet recruiting

Breast Cancer

NCT05841849

Clinical

Trials by Indication[1]

Nausea and vomiting27 trials

Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients

Completed·NNorthside Hospital, Inc.·Phase 2·NCT01370408·85 enrolled

Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

Completed·YYonsei University·Phase 4·NCT02480088·300 enrolled

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Show 24 more trials

Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

Completed·—·Phase 2·NCT02388750·96 enrolled

Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00412425·30 enrolled

An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Completed·HHelsinn Healthcare SA·Phase 3·NCT01339260·1,455 enrolled

Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery

Completed·YYonsei University·N/A·NCT01825733·196 enrolled

Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00982995·3 enrolled

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Completed·HHelsinn Healthcare SA·Phase 3·NCT01376297·413 enrolled

Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Completed·KKyungpook National University Hospital·N/A·NCT02597907·88 enrolled

An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

Completed·HHelsinn Healthcare SA·Phase 3·NCT02557035·441 enrolled

Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00684463·59 enrolled

Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

Completed·YYonsei University·N/A·NCT01169805·105 enrolled

Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

Unknown status·AAssociazione Salentina Angela Serra·Phase 2·NCT02205164·134 enrolled

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Completed·HHelsinn Healthcare SA·Phase 3·NCT00828295·150 enrolled

Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

Completed· Eisai logo

Eisai·Phase 2·NCT00967499·239 enrolled

Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Completed·IIncheon St.Mary's Hospital·N/A·NCT01476280·100 enrolled

Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01031498·150 enrolled

Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery

Unknown status·UUniversidade Federal Fluminense·Phase 3·NCT04060771·80 enrolled

An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

Completed·HHelsinn Healthcare SA·Phase 3·NCT01363479·743 enrolled

Compare Between Two Doses of Palonosetron on the Prevention of Postoperative Nausea and Vomiting in Obese Patients

Completed·IInstituto Nacional de Cancer, Brazil·Phase 4·NCT02941913·80 enrolled

Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients

Completed·HHelsinn Healthcare SA·Phase 3·NCT01442376·502 enrolled

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for the Prophylaxis of Postoperative Nausea and Vomiting (PONV) in Women Over 60 Years Undergoing Laparoscopic Cholecystectomy

Completed·HHospital Federal de Bonsucesso·Phase 4·NCT02541019·80 enrolled

Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.

Completed· Eisai logo

Eisai·Phase 2·NCT00306735·75 enrolled

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Completed·HHelsinn Healthcare SA·Phase 3·NCT01395901·670 enrolled

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

Completed·MM.D. Anderson Cancer Center·Phase 2/3·NCT03040726·53 enrolled

Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

Completed·SSamsung Medical Center·Phase 3·NCT01568268·384 enrolled

Chemotherapy-induced nausea and vomiting6 trials

Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Completed·HHangzhou Jiuyuan Gene Engineering Co. Ltd.,·Phase 2·NCT00503386·144 enrolled

MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy

Completed·AAmsterdam UMC, location VUmc·Phase 3·NCT02135510·249 enrolled

PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting

Completed·HHelsinn Healthcare SA·Phase 2·NCT03204279·67 enrolled

Show 3 more trials

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

Completed·XXijing Hospital·Phase 2·NCT00666783·208 enrolled

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Completed·GGruppo Italiano Studio Linfomi·Phase 2·NCT01018758·86 enrolled

Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

Completed·FFirst Affiliated Hospital of Harbin Medical University·Phase 3·NCT02484911·120 enrolled

Chemotherapy4 trials

Aprepitant Triple Therapy for the Prevention of CINV in Nondrinking and Young Women Who Received Moderately Emetogenic Chemotherapy

Completed·SSun Yat-sen University·Phase 3·NCT03674294·248 enrolled

Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy

Completed· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT00359567·1,140 enrolled

Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy

Withdrawn·CCostantine Albany·Phase 2·NCT03960151

Show 1 more trial

Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy

Completed·—·Phase 1/2·NCT01046240·29 enrolled

Breast Cancer2 trials

Effectiveness and Quality of Life Analysis of Palonosetron Against Ondansetron Combined With Dexamethasone and Fosaprepitant in Prevention of Acute and Delayed Emesis Associated to Chemotherapy Moderate and Highly Emetogenic in Breast Cancer.

Unknown status·IInstituto Nacional de Cancerologia de Mexico·Phase 2/3·NCT03606369·560 enrolled

Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of CINV in Breast Cancer

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT05841849·1,028 enrolled

PONV2 trials

PALONOSETRON X FOSAPREPITANT IN PONV

Unknown status·HHospital Federal de Bonsucesso·Phase 4·NCT03586817·100 enrolled

The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV

Completed·—·Phase 4·NCT02809378·150 enrolled

19 more indications

Nausea2 trials

AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors

Completed·PPETHEMA Foundation·Phase 4·NCT00415103·196 enrolled

Multi-day Doses in Prevention of Nausea and Emesis

Completed·UUniversity of Kansas Medical Center·Phase 2·NCT00600353·20 enrolled

Post Operative Nausea and Vomiting2 trials

Efficacy of Combined Palonosetron and Dexamethasone for Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Gynaecological Laparoscopic Surgery

Completed·BBangladesh Medical University·Approved·NCT07813897·76 enrolled

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

Completed·UUniversity of Malaya·Approved·NCT06540885·74 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT01909856·92 enrolled

Opioid Withdrawal1 trial

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

Completed·SStanford University·N/A·NCT00661674·10 enrolled

Cesarean Section1 trial

Prophylactic Antiemetic Efficacy of Palonosetron Versus Ondansetron for Cesarean Sections Under Regional Anesthesia

Completed·HHospital de Base·Phase 4·NCT02468323·150 enrolled

Prophylaxis1 trial

Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

Unknown status·FFudan University·Phase 3·NCT04912271·140 enrolled

Dexamethasone1 trial

Proof-of-Concept Trial of Palonosetron and Olanzapine Without Dexamethasone for the Prevention of CIN

Unknown status·HHee Jun Kim·N/A·NCT02970643·48 enrolled

Cardiac Repolarization1 trial

Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Completed·IIntarcia Therapeutics·Phase 1·NCT02650479·82 enrolled

Intraperitoneal Chemotherapy1 trial

A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT04308837·29 enrolled

Vomiting1 trial

Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery

Completed·YYonsei University·N/A·NCT02744508·202 enrolled

Lung Cancer1 trial

Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy

Unknown status·ZZhejiang University·Phase 2·NCT02445872·80 enrolled

Remifentanil1 trial

Effect of Palonosetron on Remifentanil for Preventing Emergence Cough in Female

Completed·—·N/A·NCT04563260·45 enrolled

Radiotherapy1 trial

Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

Completed·—·Phase 2·NCT00900757·57 enrolled

Ondansetron1 trial

Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing ERCP

Unknown status·TTheodor Bilharz Research Institute·Phase 4·NCT04576390·90 enrolled

Pruritus1 trial

Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron

Completed·KKyungpook National University Hospital·N/A·NCT01952626·80 enrolled

Perioperative Period1 trial

The Effect of Palonosetron on the QTc Interval During Perioperative Period

Completed·SSeoul National University Hospital·N/A·NCT01650961·100 enrolled

Idiopathic Scoliosis1 trial

Palonosetron vs Ondansetron In PONV Prophylaxis Among Idiopathic Scoliosis Patients

Completed·UUniversity of Malaya·Phase 4·NCT05956899·92 enrolled

Nephrotoxicity1 trial

Drug Disposition and Nephrotoxicity

Active, not recruiting·UUniversity of Colorado, Denver·Phase 3·NCT03817970·45 enrolled

Unspecified1 trial

Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)

Completed·YYung Shin Pharm. Ind. Co., Ltd.·Phase 4·NCT04585412·16 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 29, 2008

ALOXI

NDA NDA021372

Aug 22, 2008

ALOXI

NDA NDA022233

Mar 1, 2016

POSFREA

NDA NDA203050

Aug 22, 2016

PALONOSETRON HYDROCHLORIDE

NDA NDA207963

Nov 21, 2017

PALONOSETRON HYDROCHLORIDE

NDA NDA208109

Sources

References

[1]
ClinicalTrials.gov — 62 trial records for Palonosetron. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aloxi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Palonosetron compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Palonosetron. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208109). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Avyxa company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 3a (5-Ht3a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAvyxa

Aloxi

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q3 2029

Trials by Indication[1]

Nausea and vomiting27 trials

Chemotherapy-induced nausea and vomiting6 trials

Chemotherapy4 trials

Breast Cancer2 trials

PONV2 trials

Nausea2 trials

Post Operative Nausea and Vomiting2 trials

Efficacy and Safety1 trial

Opioid Withdrawal1 trial

Cesarean Section1 trial

Prophylaxis1 trial

Dexamethasone1 trial

Cardiac Repolarization1 trial

Intraperitoneal Chemotherapy1 trial

Vomiting1 trial

Lung Cancer1 trial

Remifentanil1 trial

Radiotherapy1 trial

Ondansetron1 trial

Pruritus1 trial

Perioperative Period1 trial

Idiopathic Scoliosis1 trial

Nephrotoxicity1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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