Aloxi(palonosetron)
Akynzeo, Aloxi (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
Combinations
Akynzeo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosnetupitant chloride hydrochloride
+
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKYNZEO | Helsinn Healthcare | N-210493 RX | 2018-04-19 | 2 products, RLD, RS |
Netupitant
+
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AKYNZEO | Helsinn Healthcare | N-205718 RX | 2014-10-10 | 1 products, RLD, RS |
Palonosetron hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PALONOSETRON HYDROCHLORIDE | Hikma Pharmaceuticals | N-207963 RX | 2016-08-22 | 1 products |
Show 4 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| akynzeo | New Drug Application | 2023-12-10 |
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
141 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 | HP_0002013 | R11.1 | 1 | 22 | 22 | 4 | 6 | 52 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | 1 | 4 | 12 | 11 | 28 |
| Neoplasms | D009369 | — | C80 | 2 | 6 | 7 | 4 | 1 | 19 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 9 | 4 | 3 | 1 | 16 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | 3 | — | 4 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | 1 | — | 2 |
| Anesthesia | D000758 | — | — | — | — | 1 | 1 | — | 2 |
| Leukemia | D007938 | — | C95 | — | — | — | 1 | — | 1 |
| Thoracica | D001468 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 2 | — | 1 | 4 |
| Colorectal neoplasms | D015179 | — | — | — | 2 | 1 | — | — | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 1 | 1 | — | 1 | 2 |
| General anesthesia | D000768 | — | — | — | — | 1 | — | 1 | 2 |
| Laparoscopy | D010535 | — | — | — | — | 1 | — | 1 | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | — | — | 1 | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | — | — | 1 | — | — | 1 |
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | 1 | — | — | 1 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | — | 1 | 1 | — | — | 1 |
| Digestive system surgical procedures | D013505 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | 1 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 2 | — | — | — | 2 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | 2 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 2 | — | — | — | 2 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | 1 | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | — | — | 1 | — | — | — | 1 |
Show 8 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 |
| 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 |
| Male breast neoplasms | D018567 | — | — | — | — | — | — | 1 | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Peritoneal neoplasms | D010534 | — | — | — | — | — | — | 1 | 1 |
| Patient reported outcome measures | D000071066 | — | — | — | — | — | — | 1 | 1 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 1 | 1 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 1 | 1 |
| Gynecologic surgical procedures | D013509 | — | — | — | — | — | — | 1 | 1 |
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
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,022 adverse events reported
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