Aloxi(palonosetron)
Akynzeo, Aloxi, Palonosetron, Posfrea (palonosetron) is a small molecule pharmaceutical. Palonosetron was first approved as Aloxi on 2003-07-25. It has been approved in Europe to treat nausea, neoplasms, and vomiting.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Palonosetron (discontinued: Aloxi, Palonosetron)
CombinationsAkynzeo (discontinued: Akynzeo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PALONOSETRON HYDROCHLORIDE | Dr Reddys Laboratories | N-203050 DISCN | 2016-03-01 | 2 products |
| PALONOSETRON HYDROCHLORIDE | Fresenius Kabi | N-208109 DISCN | 2017-11-21 | 1 products, RLD |
| ALOXI | Helsinn Healthcare | N-021372 DISCN | 2003-07-25 | 2 products, RLD |
| ALOXI | Helsinn Healthcare | N-022233 DISCN | 2008-08-22 | 1 products, RLD |
| PALONOSETRON HYDROCHLORIDE | Hikma Pharmaceuticals | N-207963 DISCN | 2016-08-22 | 1 products |
Hide discontinued
Fosnetupitant chloride hydrochloride
+
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKYNZEO | Helsinn Healthcare | N-210493 RX | 2020-05-27 | 1 products, RLD, RS |
Show 1 discontinued
Netupitant
+
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKYNZEO | Helsinn Healthcare | N-205718 RX | 2014-10-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| akynzeo | New Drug Application | 2023-12-10 |
| aloxi | 2008-09-23 | |
| palonosetron | ANDA | 2025-01-30 |
| palonosetron hydrochloride | ANDA | 2024-11-19 |
| posfrea | New Drug Application | 2025-04-29 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FOSNETUPITANT CHLORIDE HYDROCHLORIDE / PALONOSETRON HYDROCHLORIDE, AKYNZEO, HELSINN HLTHCARE | |||
| 2023-04-19 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fosnetupitant Chloride Hydrochloride / Palonosetron Hydrochloride, Akynzeo, Helsinn Hlthcare | |||
| 10624911 | 2037-06-02 | DP | |
| 11529362 | 2037-06-02 | DP | |
| 8426450 | 2032-05-23 | DS, DP | |
| 8895586 | 2032-05-23 | U-2301 | |
| 9403772 | 2032-05-23 | DP | U-2301 |
| 9908907 | 2032-05-23 | DS, DP | |
| 10208073 | 2032-05-23 | U-2301 | |
| 10717721 | 2032-05-23 | DP | |
| 11312698 | 2032-05-23 | DS, DP | |
| 10828297 | 2030-12-17 | U-2293, U-2301 | |
| 9186357 | 2030-11-18 | U-2293, U-2301 | |
| Netupitant / Palonosetron Hydrochloride, Akynzeo, Helsinn Hlthcare | |||
| 9951016 | 2035-09-25 | DS, DP | |
| 10233154 | 2035-09-25 | DP | |
| 10676440 | 2035-09-25 | DS, DP | |
| 10961195 | 2035-09-25 | DS, DP | |
| 9271975 | 2031-09-09 | U-2293 | |
| 8623826 | 2030-11-18 | U-2293 | |
| 8951969 | 2030-11-18 | DP | |
| 9943515 | 2030-11-18 | U-2293 | |
| 11559523 | 2030-11-18 | DP | U-3522 |
| 6297375 | 2023-03-17 | DP | |
| Palonosetron Hydrochloride, Aloxi, Helsinn Hlthcare | |||
| 7947724 | 2024-01-30 | DP | |
| 7947725 | 2024-01-30 | DP | |
| 7960424 | 2024-01-30 | DP | |
| 8518981 | 2024-01-30 | DP | |
| 8598218 | 2024-01-30 | DP | |
| 8598219 | 2024-01-30 | DP | |
| 8729094 | 2024-01-30 | DP | U-528 |
| 9066980 | 2024-01-30 | DP | U-528 |
| 9125905 | 2024-01-30 | DP | |
| 9173942 | 2024-01-30 | DP | |
| 9439854 | 2024-01-30 | DP | |
| 9457020 | 2024-01-30 | DP | |
| 9457021 | 2024-01-30 | DP | |
Clinical
Clinical Trials
160 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vomiting | D014839 | — | R11.1 | 2 | 31 | 37 | 15 | 21 | 103 |
| Nausea | D009325 | — | R11.0 | 1 | 27 | 33 | 14 | 17 | 90 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | 6 | 13 | 12 | 32 |
| Neoplasms | D009369 | — | C80 | 3 | 7 | 7 | 5 | 2 | 23 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 3 | 1 | 2 | 7 |
| Lymphoma | D008223 | — | C85.9 | — | 3 | — | 1 | 1 | 5 |
| Pain | D010146 | EFO_0003843 | R52 | — | 2 | — | 3 | — | 5 |
| Leukemia | D007938 | — | C95 | — | 1 | — | 1 | — | 2 |
| Anesthesia | D000758 | — | — | — | — | 1 | 1 | — | 2 |
| Scoliosis | D012600 | EFO_0004273 | M41 | — | — | — | 2 | — | 2 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | — | 2 | 1 | — | — | 3 |
| Male breast neoplasms | D018567 | — | — | — | — | 1 | — | 1 | 2 |
| General anesthesia | D000768 | — | — | — | — | 1 | — | 1 | 2 |
| Laparoscopy | D010535 | — | — | — | — | 1 | — | 1 | 2 |
| Electroacupuncture | D015671 | — | — | — | — | 2 | — | — | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | — | 1 | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | — | — | 1 | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | — | — | 1 | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | — | 1 | — | — | 1 |
| Inflammatory breast neoplasms | D058922 | — | — | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 3 | 3 | — | — | — | 4 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 2 | — | — | 1 | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | — | — | 1 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 2 | — | — | — | 3 |
| Hiv | D006678 | — | O98.7 | 1 | 2 | — | — | 1 | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | 1 | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | 1 | 2 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Amebiasis | D000562 | EFO_0007144 | A06 | 1 | — | — | — | — | 1 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 2 | 2 |
| Orthopedic procedures | D019637 | — | — | — | — | — | — | 1 | 1 |
| Sarcoma | D012509 | — | — | — | — | — | — | 1 | 1 |
| Persistent infection | D000088562 | — | — | — | — | — | — | 1 | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Peritoneal neoplasms | D010534 | — | — | — | — | — | — | 1 | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Pruritus | D011537 | — | L29 | — | — | — | — | 1 | 1 |
| Patient reported outcome measures | D000071066 | — | — | — | — | — | — | 1 | 1 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 1 | 1 |
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Palonosetron |
| INN | palonosetron |
| Description | Palonosetron is an organic heterotricyclic compound that is an antiemetic used (as its hydrochloride salt) in combination with netupitant (under the trade name Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. It has a role as an antiemetic and a serotonergic antagonist. It is a delta-lactam, an organic heterotricyclic compound and an azabicycloalkane. It is a conjugate base of a palonosetron(1+). |
| Classification | Small molecule |
| Drug class | serotonin 5-HT3 receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1c2cccc3c2[C@H](CCC3)CN1[C@@H]1CN2CCC1CC2 |
Identifiers
| PDB | — |
| CAS-ID | 135729-61-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1189679 |
| ChEBI ID | 85161 |
| PubChem CID | 6337614 |
| DrugBank | DB00377 |
| UNII ID | 5D06587D6R (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,406 adverse events reported
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