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 acer, nausea, neoplasms, and vomiting.
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Commercial
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
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
107 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 | 18 | 20 | 4 | 5 | 45 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 1 | 4 | 9 | 8 | 22 | |
| Neoplasms | D009369 | C80 | — | 4 | 7 | 4 | 1 | 15 | |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 7 | 3 | 3 | 1 | 13 |
| Lymphoma | D008223 | C85.9 | — | 1 | — | 1 | — | 2 | |
| Anesthesia | D000758 | — | — | 1 | 1 | — | 2 | ||
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | — | 1 | — | 2 |
| Leukemia | D007938 | C95 | — | — | — | 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 | — | 1 | 2 | — | 1 | 3 |
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | 1 | 1 | — | 1 | 2 | |
| General anesthesia | D000768 | — | — | 1 | — | 1 | 2 | ||
| Gastrointestinal neoplasms | D005770 | C26.9 | — | — | 1 | — | — | 1 | |
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | 1 | — | — | 1 |
| Uterine cervical neoplasms | D002583 | — | 1 | 1 | — | — | 1 | ||
| Digestive system surgical procedures | D013505 | — | — | 1 | — | — | 1 | ||
| Laparoscopy | D010535 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | — | 2 | — | — | — | 2 | |
| Colorectal neoplasms | D015179 | — | 2 | — | — | — | 2 | ||
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | 2 | — | — | — | 2 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | C34.90 | — | 1 | — | — | — | 1 | |
| Squamous cell carcinoma of head and neck | D000077195 | — | 1 | — | — | — | 1 | ||
| Squamous cell carcinoma | D002294 | — | 1 | — | — | — | 1 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Germ cell and embryonal neoplasms | D009373 | — | 1 | — | — | — | 1 | ||
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Orthopedic procedures | D019637 | — | — | — | — | 1 | 1 | ||
| Sarcoma | D012509 | — | — | — | — | 1 | 1 | ||
| Male breast neoplasms | D018567 | — | — | — | — | 1 | 1 | ||
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 1 | 1 |
| Postoperative pain | D010149 | G89.18 | — | — | — | — | 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 |
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 | 70561 |
| ChEMBL ID | CHEMBL1189679 |
| ChEBI ID | 85161 |
| PubChem CID | 6337614 |
| DrugBank | DB00377 |
| UNII ID | 5D06587D6R (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,299 adverse events reported
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