> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/palonosetron-hydrochloride-1ffe7260-fdf1-4917-b128-112505e5105b > Record changed: 2026-11-04 # Palonosetron hydrochloride Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) First approval year 2003 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) ## Development status **First approval year** 2003 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **Drug name** Palonosetron hydrochloride Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **Molecular weight** 332.88 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **Structure (SMILES)** Cl.O=C1c2cccc3c2\[C@H\](CCC3)CN1\[C@@H\]1CN2CCC1CC2 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) ### Brand names (12) - aloxi - Aloxi - palonosetron accord - Palonosetron accord - palonosetron hospira - Palonosetron hospira - palonosetron hydrochloride - Palonosetron hydrochloride - palonosetron hydrochloride component of akynzeo - Palonosetron hydrochloride component of akynzeo - posfrea - Posfrea ### Other names (33) - (3AS)-2,3,3A,4,5,6-HEXAHYDRO-2-((3S)-3-QUINUCLIDINYL)-1H-BENZ(DE)ISOQUINOLIN-1-ONE MONOHYDROCHLORIDE - 3as 2 3 3a 4 5 6 hexahydro 2 3s 3 quinuclidinyl 1h benz de isoquinolin 1 one monohydrochloride - akynzeo component palonosetron hydrochloride - AKYNZEO COMPONENT PALONOSETRON HYDROCHLORIDE - aloxi - palonocetron hydrochloride - Palonocetron hydrochloride - Palonosetron (as hydrochloride) - palonosetron as hydrochloride - palonosetron hcl - Palonosetron hcl - palonosetron hydrochloride - Palonosetron hydrochloride - PALONOSETRON HYDROCHLORIDE \[EMA EPAR\] - PALONOSETRON HYDROCHLORIDE \[JAN\] - PALONOSETRON HYDROCHLORIDE \[MART.\] - PALONOSETRON HYDROCHLORIDE \[MI\] - PALONOSETRON HYDROCHLORIDE \[ORANGE BOOK\] - PALONOSETRON HYDROCHLORIDE \[USAN\] - PALONOSETRON HYDROCHLORIDE \[USP MONOGRAPH\] - PALONOSETRON HYDROCHLORIDE \[USP-RS\] - Palonosetron hydrochloride \[WHO-DD\] - palonosetron hydrochloride ema epar - palonosetron hydrochloride jan - palonosetron hydrochloride mart And 8 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 135729-62-3 **ChEMBL ID** CHEMBL1720 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **InChIKey** OLDRWYVIKMSFFB-SSPJITILSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1720) **RxNorm IDs (RxCUI)** - 397405 **FDA ingredient codes (UNII)** - 23310D4I19 ### PubChem compound IDs (2) - 6918303 - 139071528 ## Regulatory information ### United States **Applicant** HELSINN HLTHCARE **Approval date** 25 Jul 2003 **Application number** NDA021372 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Approval status **United States (FDA)** Approved ## Pharmacology ### Drug classification **Drug name stem** \-setron #### Administration routes - Oral - Parenteral ### Mechanisms of action - **Mechanism** Serotonin 3a (5-HT3a) receptor antagonist **Action type** Antagonist **Target** 5-hydroxytryptamine receptor 3A **Protein identifier** P46098 ### Open Targets mechanisms - **Mechanism** Serotonin 3a (5-HT3a) receptor antagonist **Action type** Antagonist **Target** 5-hydroxytryptamine receptor 3A ### Investigated indications (6) - **Condition** Postoperative Nausea and Vomiting **Highest recorded phase** 4 **Condition identifier** EFO:0004888 **Subject identifier** D020250 - **Condition** Nausea **Highest recorded phase** 4 **Condition identifier** EFO:0006911 **Subject identifier** D009325 - **Condition** Vomiting **Highest recorded phase** 4 **Condition identifier** HP:0002013 **Subject identifier** D014839 - **Condition** Postoperative Nausea and Vomiting **Highest recorded phase** 4 **Condition identifier** HP:0002017 **Subject identifier** D020250 - **Condition** Nausea **Highest recorded phase** 4 **Condition identifier** HP:0002018 **Subject identifier** D009325 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0004992 **Subject identifier** D009369 ### Open Targets indications (11) - **Condition identifier** EFO\_0004888 - **Condition identifier** EFO\_0004888 **Highest recorded phase** 4 - **Condition identifier** EFO\_0006911 **Highest recorded phase** 3 - **Condition identifier** HP\_0002013 - **Condition identifier** HP\_0002013 **Highest recorded phase** 4 - **Condition identifier** HP\_0002017 - **Condition identifier** HP\_0002017 **Highest recorded phase** 4 - **Condition identifier** HP\_0002018 - **Condition identifier** HP\_0002018 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004992 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 4 ### Reported adverse events (44) - **Event** alopecia **Reports** 27 **Reporting signal score** 20.4214 - **Event** anaphylactic reaction **Reports** 19 **Reporting signal score** 14.6981 - **Event** aortic disorder **Reports** 4 **Reporting signal score** 14.7279 - **Event** aortic thrombosis **Reports** 5 **Reporting signal score** 15.9556 - **Event** appetite disorder **Reports** 6 **Reporting signal score** 14.1157 - **Event** asterixis **Reports** 6 **Reporting signal score** 19.3165 - **Event** back pain **Reports** 29 **Reporting signal score** 12.8176 - **Event** blood pressure decreased **Reports** 17 **Reporting signal score** 14.8691 - **Event** cardiac fibrillation **Reports** 4 **Reporting signal score** 12.5309 - **Event** colony stimulating factor therapy **Reports** 3 **Reporting signal score** 14.3214 - **Event** constipation **Reports** 57 **Reporting signal score** 57.4824 - **Event** deafness neurosensory **Reports** 9 **Reporting signal score** 22.5705 - **Event** dyspnoea **Reports** 72 **Reporting signal score** 26.554 - **Event** ear discomfort **Reports** 9 **Reporting signal score** 20.3764 - **Event** erythema **Reports** 32 **Reporting signal score** 19.998 - **Event** flushing **Reports** 29 **Reporting signal score** 31.2913 - **Event** haematochezia **Reports** 15 **Reporting signal score** 14.6515 - **Event** haemolysis **Reports** 17 **Reporting signal score** 45.16 - **Event** heart rate increased **Reports** 17 **Reporting signal score** 13.6498 - **Event** hypersensitivity **Reports** 29 **Reporting signal score** 15.1373 - **Event** hypotension **Reports** 36 **Reporting signal score** 14.2282 - **Event** immune thrombocytopenic purpura **Reports** 7 **Reporting signal score** 15.1244 - **Event** infusion site erythema **Reports** 9 **Reporting signal score** 20.9189 - **Event** infusion site pruritus **Reports** 9 **Reporting signal score** 30.7259 - **Event** infusion site vesicles **Reports** 9 **Reporting signal score** 44.1143 And 19 more, listed on the interactive page. ### Trial references (7) - NCT00343460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00343460) - NCT00475085 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00475085) - NCT00895245 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00895245) - NCT03367572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03367572) - NCT03578081 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03578081) - NCT04592198 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04592198) - NCT03097588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03097588) ## Dosing **Dose** 0.25 mg **Route** Intravenous **How often** As a single dose ### Conditions of use - Infuse over 30 seconds beginning approximately 30 minutes before chemotherapy ## Chemical properties **Hydrogen bond acceptors** 2 **Hydrogen bond donors** 0 **Polar surface area** 23.55 **Calculated partition coefficient (ALogP)** 2.66 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 1 **Heavy atoms** 23 **Molecular formula** C19H25ClN2O **Monoisotopic mass** 332.1655411 **Natural product** No ## National Drug Codes - 0703-4094 - 0781-3312 - 16714-834 - 25021-783 - 36000-326 - 55111-694 - 55150-186 - 63323-673 - 67457-317 - 68001-355 - 68001-708 - 69097-927 - 69639-101 - 69639-105 - 69639-106 - 71288-409 - 83831-105 - 60505-6193 - 60505-6439 - 67184-0514 - 67184-0515 ## Evidence counts **Recorded assays** 962 **Active assays** 51 ### Active assay types (3) - Confirmatory - Other - Summary ## Pharmacologic actions - Antiemetics Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000932.html) - Serotonin 5-HT3 Receptor Antagonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D058831.html) ## Related records ### Trials (38) - [A Clinical Trial of HRS5580 for Injection Combined With Palonosetron Hydrochloride for the Prevention of Postoperative Nausea and Vomiting](https://trialight.com/data/trial/a-clinical-trial-of-hrs5580-for-injection-combined-with-52322000-5d1d-42bb-bfa1-d0e59c054124.md) - A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron - A Simplified Regimen to Prevent Nausea and Vomiting Using Netupitant/Palonosetron in Germ Cell Cancer Patients Receiving Chemotherapy - Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer - Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab - An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC - An Relative Bioavailability Study of BH006 for Injection in Healthy Subjects - APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer - Bioequivalence and Safety Study of IN-A012 and Akynzeo Capsules in Male and Female Healthy Korean Subjects - Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting - Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC - Clinical Study of HR20013 for Injection in Patients With Malignant Solid Tumors - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients - Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer - Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting - Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy - Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV - Intensive Medicines Monitoring Project of Palonosetron Hydrochloride Capsules (Ruo Shan®) - NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens - Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant ### Approved for (1) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) ### Targets (1) - [HTR3A](https://trialight.com/data/target/htr3a-fe582ba5-f417-57ec-ba38-176d118be59f.md) Serotonin 3a (5-HT3a) receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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