Drugs / Palonosetron
last change Aug 2026 re-read 2 minutes ago

Palonosetron

Other / unclassified targets HTR3A via inhibition

Developed for
chemotherapy-induced toxicity · cancer · breast cancer · endometrial cancer · leukemia · lung cancer · lymphoma · poisoning
+1 more · substance-related disorder
Investigated by
Helsinn Healthcare SA · Eisai Inc. · National Cancer Institute (NCI) · Merck Sharp & Dohme LLC · Ajou University School of Medicine · Duke University
+64 more · HK inno.N Corporation · Kyungpook National University Hospital · M.D. Anderson Cancer Center · OHSU Knight Cancer Institute · PSI CRO · Parexel · University of Malaya · Xiamen LP Pharmaceutical Co., Ltd · Xijing Hospital · Alliance for Clinical Trials in Oncology · Blood and Marrow Transplant Group of Georgia · Bonsucesso Federal Hospital · Brazilian National Cancer Institute · Chinese Academy of Medical Sciences · Chinese University of Hong Kong · Clinica Universidad de Navarra, Universidad de Navarra · Dr. Edward Chow · Emerald Clinical Inc. · Fluminense Federal University · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fujian Shengdi Pharmaceutical Co., Ltd. · Gerhild Becker · Gruppo Italiano Studio Linfomi · Hangzhou Jiuyuan Gene Engineering Co. Ltd. · Helsinn Therapeutics (U.S.), Inc · Henan Cancer Hospital · Hospital de Base · Instituto Brasileiro de Controle do Cancer · JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd · Jiangsu Simcere Pharmaceutical Co., Ltd. · Joseph Ma · Joseph Roscoe · Memorial Sloan Kettering Cancer Center · National Cancer Institute of Mexico · National Institute of General Medical Sciences (NIGMS) · National Institute of Neurological Disorders and Stroke (NINDS) · Northside Hospital, Inc. · Ohio State University · Ohio State University Comprehensive Cancer Center · Oregon Health and Science University · Ottawa Hospital Research Institute · PETHEMA Foundation · Peking University Cancer Hospital & Institute · Princess Margaret Hospital, Hong Kong · Rutgers University · Samsung Medical Center · Second Affiliated Hospital, School of Medicine, Zhejiang University · Seoul National University Bundang Hospital · Seoul National University Hospital · Shanghai 6th People's Hospital · Shanghai Changzheng Hospital · Stanford University · Sun Yat-sen University · Taiho Pharmaceutical Co., Ltd. · The Physicians' Services Incorporated Foundation · Tigermed Consulting Co., Ltd · Universiti Kebangsaan Malaysia Medical Centre · University of Colorado, Denver · University of Kansas Medical Center · University of Michigan Rogel Cancer Center · University of Washington · VIFORFRANCE · Yonsei University · Zhuhai Beihai Biotech Co., Ltd

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) POSFREA 2025-04-16 fda.gov
Label expansion US (FDA) PALONOSETRON HYDROCHLORIDE 2018-12-06 fda.gov
Label expansions (3) US (FDA) ALOXI 2007-08-30 – 2014-05-27 fda.gov
Approved EU (EMA) Aloxi 2005-03-22 europa.eu
Approved US (FDA) ALOXI 2003-07-25 fda.gov

Trials 73 · started per year

today
US approved 2003
EU approved 2005
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20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07662200 Aug 2026 → Aug 2027 expected malignant germ cell tumor Ottawa Hospital Research Institute Not yet recruiting No outcome recorded
Phase 0 NCT06427681 May → Sep 2024 Zhuhai Beihai Biotech Co., Ltd Unknown No outcome recorded
Phase 12 trials
Phase 1 NCT06840769 Jun → Oct 2023 Helsinn Healthcare SA Terminated No outcome recorded
Phase 1 NCT05465681 Aug 2022 → Jan 2023 Fujian Shengdi Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01046240 Oct 2009 → Nov 2010 Clinica Universidad de Navarra, Universidad de Navarra Completed No outcome recorded
Phase 225 trials
Phase 2 NCT07692451 Jul 2026 → Jul 2027 expected chemotherapy-induced toxicity Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT06904235 Jul 2025 → Oct 2027 expected chemotherapy-induced toxicity Helsinn Healthcare SA Recruiting No outcome recorded
Phase 2 NCT05315999 May 2022 → Dec 2024 Gerhild Becker Completed No outcome recorded
Phase 2 NCT04669132 Dec 2020 → Dec 2021 chemotherapy-induced toxicity Instituto Brasileiro de Controle do Cancer Completed No outcome recorded
Phase 2 NCT05202275 Dec 2020 → Dec 2022 head and neck squamous cell carcinoma Chinese Academy of Medical Sciences Unknown No outcome recorded
Phase 2 NCT04592198 Oct 2020 → Mar 2021 chemotherapy-induced toxicity Xiamen LP Pharmaceutical Co., Ltd Completed No outcome recorded
Phase 2 NCT03386617 Feb 2018 → Dec 2027 expected breast cancer Chinese University of Hong Kong Active not recruiting No outcome recorded
Phase 2 NCT03204279 Aug 2017 → Sep 2019 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 2 NCT03097588 Apr 2017 → Feb 2020 cancer OHSU Knight Cancer Institute Completed No outcome recorded
Phase 2 NCT03008213 Jan 2017 → Jan 2018 chemotherapy-induced toxicity Joseph Ma Terminated No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03040726 May 2017 → Feb 2022 cancer M.D. Anderson Cancer Center Completed No outcome recorded
Phase 2/3 NCT03606369 Nov 2015 → Jul 2018 breast neoplasm National Cancer Institute of Mexico Unknown No outcome recorded
Phase 314 trials
Phase 3 NCT05199818 Mar 2022 → Sep 2023 chemotherapy-induced toxicity Xiamen LP Pharmaceutical Co., Ltd Unknown No outcome recorded
Phase 3 NCT03817970 Nov 2019 → Sep 2027 expected cisplatin toxicity University of Colorado, Denver Active not recruiting No outcome recorded
Phase 3 NCT04060771 Aug 2018 → Nov 2019 strabismus Fluminense Federal University Unknown No outcome recorded
Phase 3 NCT03403712 Mar → Sep 2018 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT02517021 Nov 2015 → Aug 2016 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT02557035 Oct 2015 → Mar 2016 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT01568268 Jan → Jun 2012 Samsung Medical Center Completed No outcome recorded
Phase 3 NCT01442376 Sep 2011 → Oct 2012 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT01363479 Jul 2011 → Nov 2012 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 3 NCT01395901 Jun 2011 → Mar 2012 Helsinn Healthcare SA Completed No outcome recorded
Phase 416 trials
Phase 4 NCT07482891 Mar → Oct 2026 expected chemotherapy-induced toxicity Shanghai 6th People's Hospital Recruiting No outcome recorded
Phase 4 NCT06540885 Jan 2025 → Jul 2026 overdue idiopathic scoliosis University of Malaya Recruiting No outcome recorded
Phase 4 NCT06726291 Feb 2024 → Dec 2025 overdue endometrial cancer Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Recruiting No outcome recorded
Phase 4 NCT05841849 Jul 2023 → Jul 2028 expected breast cancer, chemotherapy-induced toxicity Second Affiliated Hospital, School of Medicine, Zhejiang University Not yet recruiting No outcome recorded
Phase 4 NCT05956899 Jun 2023 → Mar 2024 idiopathic scoliosis University of Malaya Completed No outcome recorded
Phase 4 NCT03831633 Sep 2018 → Jul 2019 VIFORFRANCE Unknown No outcome recorded
Phase 4 NCT06043336 May 2018 → May 2019 Universiti Kebangsaan Malaysia Medical Centre Completed No outcome recorded
Phase 4 NCT02941913 Oct 2016 → Feb 2018 Brazilian National Cancer Institute Completed No outcome recorded
Phase 4 NCT02809378 Jun 2016 → Apr 2017 Ajou University School of Medicine Completed No outcome recorded
Phase 4 NCT02541019 Oct 2015 → Jan 2017 Bonsucesso Federal Hospital Completed No outcome recorded
Phase not applicable11 trials
NCT07442890 Apr 2026 → Apr 2028 expected lung cancer Henan Cancer Hospital Not yet recruiting No outcome recorded
NCT05690802 May 2022 → May 2027 expected Xijing Hospital Recruiting No outcome recorded
NCT04563260 Oct 2020 → Mar 2021 gallbladder disorder Ajou University School of Medicine Completed No outcome recorded
NCT04507711 Sep 2020 → Nov 2023 blood coagulation disease Seoul National University Bundang Hospital Unknown No outcome recorded
NCT02597907 Jul 2014 → May 2015 Kyungpook National University Hospital Completed No outcome recorded
NCT01952626 Apr 2013 → Jun 2014 poisoning Kyungpook National University Hospital Completed No outcome recorded
NCT01650961 Jul → Dec 2012 Seoul National University Hospital Completed No outcome recorded
NCT01640340 Jan → Aug 2011 cancer Ohio State University Comprehensive Cancer Center Completed No outcome recorded
NCT01169805 Aug 2010 → Jun 2011 non-congenital cyst of kidney Yonsei University Completed No outcome recorded
NCT00661674 Apr → Aug 2008 substance-related disorder Stanford University Completed No outcome recorded
Also used as a comparator or background therapy in 55 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02650479 Background Jan → Apr 2016 Intarcia Therapeutics Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00412425 Comparator Nov 2006 → May 2009 melanoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 210 trials
Phase 2 NCT07709897 Background Jul → Dec 2026 expected Fujian Shengdi Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT07617246 Comparator Nov 2025 → Jan 2027 expected esophageal cancer, lung cancer Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2 NCT04308837 Background Dec 2018 → Aug 2025 gastric cancer Icahn School of Medicine at Mount Sinai Unknown No outcome recorded
Phase 2 NCT03960151 Background May 2018 → May 2021 germ cell tumor Costantine Albany Withdrawn No outcome recorded
Phase 2 NCT02445872 Background Dec 2015 → May 2016 chemotherapy-induced toxicity, lung cancer Zhejiang University Unknown No outcome recorded
Phase 320 trials
Phase 3 NCT07081256 Comparator Jan → Aug 2025 chemotherapy-induced toxicity Qilu Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT06554184 Comparator Sep 2024 → Jul 2025 chemotherapy-induced toxicity Fujian Shengdi Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 3 NCT06331520 Background May 2024 → Aug 2025 chemotherapy-induced toxicity Fudan University Completed No outcome recorded
Phase 3 NCT06200168 Background Jan 2024 → Oct 2026 expected Jiuda Zhao Recruiting No outcome recorded
Phase 3 NCT05509634 Comparator Sep 2022 → Jun 2023 Fujian Shengdi Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 411 trials
Phase 4 NCT07637968 Background Jun 2026 → Jan 2027 expected Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 4 NCT07254416 Background Dec 2025 → Dec 2026 expected Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 4 NCT04817189 Comparator Feb 2021 → Jul 2024 chemotherapy-induced toxicity Helsinn Healthcare SA Completed No outcome recorded
Phase 4 NCT04576390 Comparator Oct 2020 → Apr 2021 Theodor Bilharz Research Institute Unknown No outcome recorded
Phase 4 NCT03586817 Comparator Mar 2019 Bonsucesso Federal Hospital Unknown No outcome recorded
Phase not applicable12 trials
NCT07480785 Background Jan 2026 → Oct 2027 expected gallstones, leiomyoma, ovarian neoplasm Zhejiang University Recruiting No outcome recorded
NCT03601871 Background Jul 2018 → Jun 2020 chemotherapy-induced toxicity Yunpeng Liu Unknown No outcome recorded
NCT03933605 Comparator Jul 2017 → Feb 2019 Yeungnam University College of Medicine Completed No outcome recorded
NCT02970643 Background Jul 2016 → Sep 2017 chemotherapy-induced toxicity Hee Jun Kim Unknown No outcome recorded
NCT02625181 Background Jul 2016 → Nov 2017 Vanderbilt University Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2018-03-23 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces the Launch of a Generic Version of ALOXI® in the United States tevapharm.com

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 133 sources stand behind the page.

FieldValueCited text
Known as Palonosetrón “BACKGROUND: This phase I trial aimed to assess the pharmacokinetics (PK), safety, and preliminary efficacy of a single dose of HR20013 (mixed formulation of fosrolapitant and...” PMID 40866861 Aug 2025
122

“Efficacy and safety of palonosetron as salvage treatment in the prevention of chemotherapy-induced nausea and vomiting in patients receiving low emetogenic chemotherapy (LEC).” PMID 22733373 Jun 2012

“Olanzapine 2.5 mg per day orally on days 1 through 4 + fosaprepitant 150 mg intravenous (IV) or aprepitant injectable emulsion 130 mg IV + palonosetron 0.25 mg” NCT06200168

“Dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure.” NCT07480785

“Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3” NCT03601871

“The registered product Akynzeo® (235 mg fosnetupitant/0.25 mg palonosetron) solution for intravenous injection” NCT06840769

“flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg” NCT02114463

“flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg” NCT02094339

“Oral Fixed-dose Combination of 300 mg Netupitant and 0.50 mg Palonosetron” NCT03386617

“0.25 mg palonosetron intravenously 30 minutes (±1 minute)” NCT06427681

“Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.” NCT01736917

Palonosetrón: 0.25 mg iv every 48 hours, starting day 1” NCT00415103

“containing 300 mg netupitant and 0.5 mg palonosetron).” NCT03831633

“Palonosetron 0.56 mg, once daily, on chemotherapy day;” NCT04669132

“Palonosetron: 0.25 mg d1 intravenous” NCT04437017

“palonosetron” NCT01843868

“Palonosetron” NCT05202275

NCT06904235

NCT00475085

NCT01872494

NCT01363479

NCT07617246

NCT02597907

NCT00661674

NCT01825733

NCT03040726

NCT01481831

NCT05956899

NCT01482468

NCT01395901

NCT01031498

NCT02116530

NCT04817189

NCT05841849

NCT04912271

NCT02445872

NCT02468323

NCT01640340

NCT01018758

NCT06554184

NCT01478165

NCT04576390

NCT04060771

NCT01442376

NCT00306735

NCT00503386

NCT02809378

NCT01476280

NCT07637968

NCT07254416

NCT05509634

NCT06331520

NCT00828295

NCT03008213

NCT02203253

NCT01339260

NCT04563260

NCT06540885

NCT02205164

NCT03960151

NCT03578081

NCT00666783

NCT02744508

NCT01088022

NCT00967499

NCT02557035

NCT02625181

NCT03204279

NCT01952626

NCT01376297

NCT02635828

NCT02388750

NCT05199818

NCT00900757

NCT00982995

NCT00600353

NCT02290470

NCT03817970

NCT04592198

NCT01046240

NCT04507711

NCT02541019

NCT02941913

NCT03933605

NCT03606369

NCT01370408

NCT01169805

NCT02650479

NCT06726291

NCT07709897

NCT02480088

NCT06043336

NCT07482891

NCT00687011

NCT02532634

NCT00952133

NCT02970643

NCT03403712

NCT02484911

NCT00359567

NCT05690802

NCT01909856

NCT00343863

NCT05315999

NCT03674294

NCT01568268

NCT00684463

NCT07442890

NCT03586817

NCT07692451

NCT05439798

NCT04853147

NCT01650961

NCT02933099

NCT00410488

NCT07662200

NCT02517021

NCT00412425

NCT00636805

NCT04308837

NCT00903396

NCT02135510

NCT00415103

Known as Aloxi “Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle” NCT01339260
6

“single oral dose of palonosetron compared to a single intravenous dose of palonosetron (Aloxi, an antiemetic drug)” NCT01363479

“.075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery to see if this reduces PONV.” NCT00952133

“Palonosetron (Aloxi) and Dexamethasone” NCT00636805

“IV palonosetron 0.25 Mg (ALOXI®)” NCT04592198

“Palonosetron Injection [Aloxi]” NCT04563260

Aloxi (Palonosetron HCl)” NCT00306735

Known as Aloxi (palonosetron) Aloxi (palonosetron)NCT01568268
Known as NSC-743769 ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as PALO “BACKGROUND: NEPA, an oral fixed combination of the NK1RA netupitant (300 mg) and clinically/pharmacologically distinct 5-HT3RA palonosetron (PALO, 0.50 mg), is the first fixed...” PMID 29722791 Jul 2018
2

“This post-hoc analysis evaluated the efficacy of NEPA, a fixed combination of netupitant (NETU [NK1RA]) and palonosetron (PALO [5-HT3RA]) in BC patients from two phase III studies.” PMID 28285236 Mar 2017

Palonosetron (PALO)” NCT00900757

Known as Palonocetron hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as Palonosetron (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as Palonosetron accord ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as Palonosetron HCl Palonosetron HCl Buccal Film 0.25 Mg” NCT04592198
2

Palonosetron HCl Buccal Film 0.5 mg” NCT05199818

“Aloxi (Palonosetron HCl)” NCT00306735

Known as Palonosetron hospira ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as Palonosetron Hydrochloride “Fosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy.” NCT07617246
16

palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy” NCT05509634

Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist” NCT00967499

“Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV;” NCT07442890

Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution” NCT04592198

“Patients receive palonosetron hydrochloride IV on day 1.” NCT00903396

Palonosetron hydrochloride IV injection” NCT05199818

“Netupitant/Palonosetron HydrochlorideNCT07662200

“Drug: Palonosetron HydrochlorideNCT01481831

“Drug: Palonosetron HydrochlorideNCT03040726

“Drug: Palonosetron HydrochlorideNCT05315999

NCT00381862

NCT00895245

NCT03097588

NCT07081256

NCT00343460

NCT00553059

Known as Palonosetron hydrochloride component of akynzeo ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as palonosetron hydrochloride injection Palonosetron hydrochloride injection: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) infusion time is 30 seconds (﹢5seconds)” NCT06427681
1

“fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone” NCT07692451

Known as Palonosetron injection “Active Comparator: Drug:HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug:Palonosetron injection Drug: Dexamethasone” NCT07692451
Known as palonosetron(aloxi) palonosetron(aloxi)NCT02532634
Known as Palonosetron, (3as, 3s)- ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as Posfrea ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Known as RS-25259-197 ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679
Action Inhibit “Palonosetron is a second-generation 5-hydroxytryptamine 3 (5-HT(3))-receptor antagonist” PMID 19135415 Jan 2009
1

“Serotonin 3a (5-HT3a) receptor antagonist” CHEMBL1189679

Modality Other / unclassified “Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist” NCT00967499
Route Intravenous “Patients were randomized to subcutaneous APF530 250 or 500 mg (granisetron 5 or 10 mg) or intravenous palonosetron 0.25 mg during cycle 1.” PMID 26921245 Feb 2016
Target HTR3A “Serotonin 3a (5-HT3a) receptor antagonist” CHEMBL1189679