Drugs / Palonosetron
Palonosetron
also known as
palonosetron hydrochloride · Aloxi · PALO · Palonosetron HCl · Palonosetron hydrochloride injection · Aloxi (palonosetron) · NSC-743769 · Palonocetron hydrochloride · +9 more
Other / unclassified targets HTR3A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 74 · started per year
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EU approved 2005
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 226 trials | ||||||
| Phase 2 | NCT07841210 | Sep 2026 → Jan 2028 expected | — | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Active not recruiting | No outcome recorded |
| 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 | NCT02388750 | Apr 2015 → Aug 2017 | — | Dr. Edward Chow | Completed | No outcome recorded |
| Phase 2 | NCT01370408 | Feb 2012 → Mar 2016 | chemotherapy-induced toxicity | Northside Hospital, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01909856 | Oct 2011 → Apr 2014 | cancer | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00982995 | Nov 2010 → May 2013 | — | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01054456 | Oct 2009 → Dec 2010 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00903396 | Sep 2009 → Jan 2011 | anus cancer, appendix carcinoma, carcinoid tumor, extrahepatic bile duct carcinoma +5 | Alliance for Clinical Trials in Oncology | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00900757 | Aug 2009 → Dec 2012 | malignant glioma | Duke University | Completed | No outcome recorded |
| Phase 2 | NCT00636805 | May 2008 → Jan 2013 | brain cancer | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00600353 | Oct 2007 → Jan 2010 | plasma cell myeloma | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT01018758 | Jul 2006 → Jul 2008 | chemotherapy-induced toxicity, non-Hodgkin lymphoma | Gruppo Italiano Studio Linfomi | Completed | No outcome recorded |
| Phase 2 | NCT00381862 | Jun 2006 → Mar 2008 | colorectal cancer | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT00503386 | Apr → Oct 2006 | — | Hangzhou Jiuyuan Gene Engineering Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00306735 | Mar 2006 → Dec 2007 | plasma cell myeloma | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01031498 | Sep 2005 → Sep 2009 | acute myeloid leukemia, chemotherapy-induced toxicity | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00666783 | — | chemotherapy-induced toxicity | Xijing Hospital | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT03040726 | May 2017 → Feb 2022 | cancer | M.D. Anderson Cancer Center | Completed | Missed primary |
| Phase 2/3 | NCT03606369 | Nov 2015 → Jul 2018 | breast neoplasm | National Cancer Institute of Mexico | Unknown | No outcome recorded |
| Phase 314 trials · 3 met primary | ||||||
| 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 | Met primary |
| 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 3 | NCT01339260 | Apr 2011 → Nov 2012 | chemotherapy-induced toxicity | Helsinn Healthcare SA | Completed | Met primary |
| Phase 3 | NCT00828295 | Aug → Dec 2008 | — | Helsinn Healthcare SA | Completed | No outcome recorded |
| Phase 3 | NCT00475085 | Dec 2006 → Dec 2012 | — | Joseph Roscoe | Completed | Mixed |
| Phase 3 | NCT00359567 | Jul 2006 → May 2007 | chemotherapy-induced toxicity | Taiho Pharmaceutical Co., Ltd. | Completed | Met primary |
| 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 | NCT02468323 | Oct 2015 → Feb 2017 | — | Hospital de Base | Completed | No outcome recorded |
| Phase 4 | NCT02541019 | Oct 2015 → Jan 2017 | — | Bonsucesso Federal Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01481831 | Jul 2011 → Aug 2012 | chemotherapy-induced toxicity, neoplasm | Shanghai Changzheng Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02635828 | Oct 2009 → May 2011 | — | Ohio State University | Completed | No outcome recorded |
| Phase 4 | NCT00684463 | Apr 2007 → Feb 2008 | neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00415103 | Nov 2006 → Sep 2009 | leukemia, lymphoma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 4 | NCT00687011 | Oct 2006 → Oct 2008 | neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase not applicable11 trials · 2 met primary | ||||||
| — | 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 | Met primary |
| — | 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 | Met primary |
| — | NCT00343863 | Jan 2006 → Dec 2010 | male breast carcinoma | University of Washington | Completed | No outcome recorded |
| Comparator or background therapy58 trials | ||||||
| Phase 1 | NCT07817004 Comparator | Sep → Nov 2026 expected | chemotherapy-induced toxicity | Qilu Pharmaceutical (Hainan) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02650479 Background | Jan → Apr 2016 | — | Intarcia Therapeutics | Completed | No outcome recorded |
| Phase 1/2 | NCT00412425 Comparator | Nov 2006 → May 2009 | melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT07848984 Background | Oct 2026 → Aug 2028 expected | breast neoplasm | Second Affiliated Hospital, Zhejiang University, School of Medicine | Not yet recruiting | No outcome recorded |
| 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 Stop: Business |
| Phase 2 | NCT02445872 Background | Dec 2015 → May 2016 | chemotherapy-induced toxicity, lung cancer | Zhejiang University | Unknown | No outcome recorded |
| Phase 2 | NCT02290470 Background | Apr 2014 → Nov 2015 | — | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Unknown | No outcome recorded |
| Phase 2 | NCT01736917 Background | Jan 2013 → Mar 2015 | chemotherapy-induced toxicity | Lawrence Einhorn | Completed | No outcome recorded |
| Phase 2 | NCT02205164 Comparator | Oct 2011 → Aug 2014 | chemotherapy-induced toxicity | Associazione Salentina Angela Serra | Unknown | Missed primary |
| Phase 2 | NCT00967499 Comparator | Jul → Dec 2009 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00895245 Background | Feb 2009 → Sep 2010 | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, lip and oral cavity squamous cell carcinoma, nasopharyngeal squamous cell carcinoma +1 | University of Washington | Terminated | No outcome recorded |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT05439798 Comparator | Jun 2022 → Apr 2023 | — | Selcuk University | Unknown | No outcome recorded |
| Phase 3 | NCT04912271 Comparator | Jun 2021 → Jun 2022 | chemotherapy-induced toxicity | Fudan University | Unknown | Met primary |
| Phase 3 | NCT04853147 Background | Apr 2021 → Apr 2022 | — | Sixth Affiliated Hospital, Sun Yat-sen University | Completed | Met primary |
| Phase 3 | NCT04437017 Comparator | Feb 2020 → May 2022 | chemotherapy-induced toxicity | Fifth Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 3 | NCT03578081 Background | Nov 2018 → Nov 2021 | cancer | Alliance for Clinical Trials in Oncology | Completed | Missed primary |
| Phase 3 | NCT02933099 Comparator | Oct 2016 → Apr 2018 | chemotherapy-induced toxicity | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 3 | NCT03674294 Background | Aug 2015 → Mar 2020 | chemotherapy-induced toxicity, digestive system neoplasm | Sun Yat-sen University | Completed | Met primary |
| Phase 3 | NCT02484911 Background | May 2015 → Sep 2016 | chemotherapy-induced toxicity | First Affiliated Hospital of Harbin Medical University | Completed | Missed primary |
| Phase 3 | NCT02116530 Background | Aug 2014 → Apr 2015 | cancer of unknown primary site, hematopoietic and lymphoid cell neoplasm | Alliance for Clinical Trials in Oncology | Completed | Met primary |
| Phase 3 | NCT02203253 Comparator | Jul 2014 → Jul 2016 | neoplasm | China Medical University, China | Completed | No outcome recorded |
| Phase 3 | NCT02135510 Comparator | Jun 2013 → Mar 2019 | cancer | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 3 | NCT01376297 Comparator | Jul 2011 → Sep 2012 | chemotherapy-induced toxicity | Helsinn Healthcare SA | Completed | No outcome recorded |
| Phase 3 | NCT01088022 Background | Apr 2010 → Mar 2013 | — | Azienda Ospedaliera di Perugia | Unknown | No outcome recorded |
| Phase 3 | NCT00553059 Background | May 2008 → Aug 2014 | cancer of unknown primary site, chemotherapy-induced toxicity | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00343460 Comparator | Jun 2006 → Sep 2008 | cancer of unknown primary site | Heron Therapeutics | Completed | Met primary |
| 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 | NCT07813897 Comparator | Sep 2025 → May 2026 | — | Bangladesh Medical University | Completed | No outcome recorded |
| Phase 4 | NCT04817189 Comparator | Feb 2021 → Jul 2024 | chemotherapy-induced toxicity | Helsinn Healthcare SA | Completed | Met primary |
| 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 4 | NCT02532634 Comparator | Aug 2015 → May 2018 | cancer | Kangdong Sacred Heart Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02480088 Comparator | Sep 2014 → Mar 2015 | — | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02114463 Background | Mar 2014 → Aug 2016 | — | Guangzhou General Hospital of Guangzhou Military Command | Unknown | No outcome recorded |
| Phase 4 | NCT02094339 Background | Mar 2014 → Jun 2016 | — | Guangzhou General Hospital of Guangzhou Military Command | Unknown | No outcome recorded |
| Phase 4 | NCT01872494 Comparator | May 2013 → Feb 2014 | — | Guangzhou General Hospital of Guangzhou Military Command | Completed | No outcome recorded |
| Phase 4 | NCT00952133 Comparator | Jul 2009 → Jul 2010 | — | NYU Langone Health | Completed | Missed primary |
| — | 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 |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT02970643 Background | Jul 2016 → Sep 2017 | chemotherapy-induced toxicity | Hee Jun Kim | Unknown | No outcome recorded |
| — | NCT02744508 Comparator | Jul 2015 → Mar 2017 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01482468 Comparator | Mar → Jul 2012 | — | Incheon St.Mary's Hospital | Unknown | No outcome recorded |
| — | NCT01843868 Background | Jan 2012 → Jun 2015 | non-Hodgkin lymphoma | Australasian Leukaemia and Lymphoma Group | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01478165 Comparator | Sep → Nov 2011 | — | Incheon St.Mary's Hospital | Completed | No outcome recorded |
| — | NCT01825733 Comparator | Aug 2011 → Jul 2012 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT01476280 Comparator | May → Aug 2011 | — | Incheon St.Mary's Hospital | Completed | No outcome recorded |
| — | NCT00410488 Comparator | Dec 2006 → Jun 2011 | sarcoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-02-18 | Helsinn Healthcare SA | Regulatory Helsinn announces European Commission approval of AKYNZEO® Oral Suspension helsinn.com ↗
Lugano, Switzerland – February 18th, 2026 – Helsinn Healthcare SA (“Helsinn”), a global pharmaceutical group focused on supporting patients with cancer and chronic diseases, today announced that the European Commission (EC) has granted marketing authorization for the new oral suspension formulation of AKYNZEO® (netupitant/palonosetron) on 12th of February 2026. |
| 2026-02-05 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药注射用磷罗拉匹坦帕洛诺司琼新适应症上市许可申请获受理 hengrui.com ↗ |
| 2025-10-17 | Helsinn Healthcare SA | Results Results from the MyRisk clinical trial, accepted for publication in the Annals of Oncology, will be presented today at ESMO 2025 as an oral presentation helsinn.com ↗
The primary endpoint was met; patients receiving AKYNZEO® were significantly more likely to achieve a complete response (CR: no emesis and no use of rescue medication) than those in the SOC arm in the overall phase (0-120 h after |
| 2023-06-12 | Helsinn Healthcare SA | Results Helsinn announces publication of data evaluating impact of AKYNZEO® (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs helsinn.com ↗
Referring to the details of the publication below, these real-world data showed that healthcare resource utilization, such as CINV-related visits were significantly lower after AKYNZEO® compared to fosaprepitant/palonosetron (APPA). |
| 2023-02-03 | Helsinn Healthcare SA | Results Helsinn announces publication of new data evaluating impact of NEPA (netupitant/palonosetron) on hospital costs helsinn.com ↗
Results from the study indicate that CINV-related hospitalization costs were significantly lower in patients who received NEPA compared to aprepitant/fosaprepitant with ondansetron (APON) or aprepitant/fosaprepitant with palonosetron (APPA) (P <.0001 for both comparisons). |
| 2023-01-04 | Helsinn Healthcare SA | Results Helsinn publishes results from a secondary analysis of a Phase 3 trial in patients with CINV in The Oncologist helsinn.com ↗
The analysis indicated that patients who experienced CR in their first cycle had a 93% or higher CR rates in subsequent cycles. |
| 2021-02-15 | Upsher-Smith Laboratories | Regulatory Sawai Receives Approvals for Eight Generic Drugs with 20 Strengths upsher-smith.com ↗
Osaka, Japan – February 15, 2021 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Kenzo Sawai) received approvals by the Ministry of Health, Labour and Welfare for eight generic drugs with 20 strengths. |
| 2014-10-14 | Eisai Inc. | Regulatory U.S. FDA APPROVES ANTIEMETIC AGENT AKYNZEO® FOR PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) World’s First Oral Fixed Combination Targeting Two Critical Pathways Involved in CINV eisai.com ↗ |
| 2014-05-29 | Eisai Inc. | Regulatory ANTIEMETIC AGENT ALOXI® APPROVED FOR CHILDREN BY THE U.S. FDA U.S. MARKET EXCLUSIVITY EXTENDED BY SIX MONTHS TO OCTOBER 13, 2015 eisai.com ↗ |
| 2008-08-24 | Eisai Inc. | Regulatory FDA Approves ALOXI® (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting eisai.com ↗
the U.S. Food and Drug Administration (FDA) has approved a new oral formulation of ALOXI® (palonosetron hydrochloride) |
| 2008-03-03 | Eisai Inc. | Regulatory FDA APPROVES ALOXI® (PALONOSETRON HCL) INJECTION FOR PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING eisai.com ↗ |
All press releases naming this drug 24 releases
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 137 sources stand behind the page.
| Field | Value | Cited 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 2025126“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 ↗ “5-HT3 receptor antagonists may include palonosetron or ondansetron.” NCT07848984 ↗ “0.25 mg palonosetron intravenously 30 minutes (±1 minute)” NCT06427681 ↗ |
| 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 20182“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 ↗ |
| Known as | Palonosetron hospira | ChEMBL registry synonym — accepted as the source's own label CHEMBL1189679 ↗ |
| Known as | palonosetron hydrochloride | “the test product QLM2010 (18 mL: aprepitant 130 mg and palonosetron hydrochloride 0.25 mg, manufactured by Qilu Pharmaceutical \[Hainan\] Co., Ltd.)” NCT07817004 ↗17“Fosrolapitant and Palonosetron Hydrochloride for Injection: Intravenous drip for 1 hour (+10 minutes), once before each cycle of chemotherapy.” NCT07617246 ↗ “palonosetron hydrochloride injection: Drug for preventing nausea and vomiting caused by chemotherapy” NCT05509634 ↗ “Rolapitant Palonosetron (Rolapitant 218 mg and Palonosetron Hydrochloride 0.25 mg), IV;” NCT07442890 ↗ “Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist” NCT00967499 ↗ “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 Hydrochloride” NCT07662200 ↗ “Drug: Palonosetron Hydrochloride” NCT05315999 ↗ “Drug: Palonosetron Hydrochloride” NCT03040726 ↗ |
| 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 20091“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 ↗ |