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Drug ReportsPalonosetron
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
neoplasmsD009369
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Palonosetron (discontinued: Aloxi, Palonosetron)
Combinations
Akynzeo (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 HYDROCHLORIDEDr Reddys LaboratoriesN-203050 DISCN2016-03-01
2 products
PALONOSETRON HYDROCHLORIDEFresenius KabiN-208109 DISCN2017-11-21
1 products, RLD
ALOXIHelsinn HealthcareN-021372 DISCN2003-07-25
2 products, RLD
ALOXIHelsinn HealthcareN-022233 DISCN2008-08-22
1 products, RLD
PALONOSETRON HYDROCHLORIDEHikma PharmaceuticalsN-207963 DISCN2016-08-22
1 products
Hide discontinued
Fosnetupitant chloride hydrochloride
+
Palonosetron hydrochloride
Tradename
Company
Number
Date
Products
AKYNZEOHelsinn HealthcareN-210493 RX2020-05-27
1 products, RLD, RS
Show 1 discontinued
Netupitant
+
Palonosetron hydrochloride
Tradename
Company
Number
Date
Products
AKYNZEOHelsinn HealthcareN-205718 RX2014-10-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
akynzeoNew Drug Application2023-12-10
aloxi2008-09-23
palonosetronANDA2024-12-17
palonosetron hydrochlorideANDA2024-11-19
posfreaNew Drug Application2024-09-26
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
FOSNETUPITANT CHLORIDE HYDROCHLORIDE / PALONOSETRON HYDROCHLORIDE, AKYNZEO, HELSINN HLTHCARE
2023-04-19NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Fosnetupitant Chloride Hydrochloride / Palonosetron Hydrochloride, Akynzeo, Helsinn Hlthcare
106249112037-06-02DP
115293622037-06-02DP
84264502032-05-23DS, DP
88955862032-05-23U-2301
94037722032-05-23DPU-2301
99089072032-05-23DS, DP
102080732032-05-23U-2301
107177212032-05-23DP
113126982032-05-23DS, DP
108282972030-12-17U-2293, U-2301
91863572030-11-18U-2293, U-2301
Netupitant / Palonosetron Hydrochloride, Akynzeo, Helsinn Hlthcare
99510162035-09-25DS, DP
102331542035-09-25DP
106764402035-09-25DS, DP
109611952035-09-25DS, DP
92719752031-09-09U-2293
86238262030-11-18U-2293
89519692030-11-18DP
99435152030-11-18U-2293
115595232030-11-18DPU-3522
62973752023-03-17DP
Palonosetron Hydrochloride, Aloxi, Helsinn Hlthcare
79477242024-01-30DP
79477252024-01-30DP
79604242024-01-30DP
85189812024-01-30DP
85982182024-01-30DP
85982192024-01-30DP
87290942024-01-30DPU-528
90669802024-01-30DPU-528
91259052024-01-30DP
91739422024-01-30DP
94398542024-01-30DP
94570202024-01-30DP
94570212024-01-30DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A04: Antiemetics and antinauseants
— A04A: Antiemetics and antinauseants
— A04AA: Serotonin (5ht3) antagonists
— A04AA05: Palonosetron
— A04AA55: Palonosetron, combinations
HCPCS
Code
Description
J1454
Injection, fosnetupitant 235 mg and palonosetron 0.25 mg
J2469
Injection, palonosetron hcl, 25 mcg
J8655
Netupitant 300 mg and palonosetron 0.5 mg, oral
Clinical
No data
Drug
General
Drug common namePalonosetron
INNpalonosetron
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 classserotonin 5-HT3 receptor antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C1c2cccc3c2[C@H](CCC3)CN1[C@@H]1CN2CCC1CC2
Identifiers
PDB—
CAS-ID135729-61-2
RxCUI—
ChEMBL IDCHEMBL1189679
ChEBI ID85161
PubChem CID6337614
DrugBankDB00377
UNII ID5D06587D6R (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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