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fosnetupitant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| neurokinin NK1 (substance P) receptor antagonist | 5283 | 1703748-89-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Netupitant is a selective antagonist of human substance P/neurokinin 1 (NK-1) receptors. Delayed emesis has been largely associated with the activation of tachykinin family neurokinin 1 (NK-1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 1.40 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 19, 2018 | FDA | HELSINN HLTHCARE | |
| March 28, 2022 | PMDA | Taiho Pharmaceutical Co., Ltd. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 58.77 | 39.80 | 31 | 1023 | 158318 | 90469075 |
| Neutropenia | 48.65 | 39.80 | 31 | 1023 | 224873 | 90402520 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Hypoalbuminaemia | 44.46 | 38.03 | 15 | 785 | 15595 | 42604940 |
| Nausea | 38.86 | 38.03 | 42 | 758 | 396757 | 42223778 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Triple negative breast cancer | 234.51 | 31.72 | 33 | 2053 | 499 | 110586714 |
| Febrile neutropenia | 64.82 | 31.72 | 51 | 2035 | 316716 | 110270497 |
| Decreased appetite | 63.60 | 31.72 | 60 | 2026 | 475786 | 110111427 |
| Neutropenia | 61.37 | 31.72 | 53 | 2033 | 374567 | 110212646 |
| Neutrophil count decreased | 60.38 | 31.72 | 34 | 2052 | 120907 | 110466306 |
| Hypoalbuminaemia | 52.64 | 31.72 | 20 | 2066 | 28954 | 110558259 |
| Nausea | 49.22 | 31.72 | 85 | 2001 | 1235605 | 109351608 |
| Flushing | 43.12 | 31.72 | 26 | 2060 | 104710 | 110482503 |
| Ultrasound foetal abnormal | 34.57 | 31.72 | 5 | 2081 | 92 | 110587121 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| CHEBI has role | CHEBI:50919 | antiemetic |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chemotherapy-induced nausea and vomiting | indication | 236084000 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.75 | acidic |
| pKa2 | 3.93 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | AKYNZEO | HELSINN HLTHCARE | N210493 | May 27, 2020 | RX | SOLUTION | INTRAVENOUS | 9186357 | Nov. 18, 2030 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | AKYNZEO | HELSINN HLTHCARE | N210493 | April 19, 2018 | DISCN | POWDER | INTRAVENOUS | 9186357 | Nov. 18, 2030 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | AKYNZEO | HELSINN HLTHCARE | N210493 | May 27, 2020 | RX | SOLUTION | INTRAVENOUS | 10828297 | Dec. 17, 2030 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | AKYNZEO | HELSINN HLTHCARE | N210493 | April 19, 2018 | DISCN | POWDER | INTRAVENOUS | 10828297 | Dec. 17, 2030 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | AKYNZEO | HELSINN HLTHCARE | N210493 | May 27, 2020 | RX | SOLUTION | INTRAVENOUS | 10208073 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | AKYNZEO | HELSINN HLTHCARE | N210493 | May 27, 2020 | RX | SOLUTION | INTRAVENOUS | 8895586 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | AKYNZEO | HELSINN HLTHCARE | N210493 | May 27, 2020 | RX | SOLUTION | INTRAVENOUS | 9403772 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | AKYNZEO | HELSINN HLTHCARE | N210493 | April 19, 2018 | DISCN | POWDER | INTRAVENOUS | 10208073 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | AKYNZEO | HELSINN HLTHCARE | N210493 | April 19, 2018 | DISCN | POWDER | INTRAVENOUS | 8895586 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
| EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | AKYNZEO | HELSINN HLTHCARE | N210493 | April 19, 2018 | DISCN | POWDER | INTRAVENOUS | 9403772 | May 23, 2032 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMOTHERAPY |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Substance-P receptor | GPCR | ANTAGONIST | Ki | 9.02 | SCIENTIFIC LITERATURE | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| T672P80L2S | UNII |
| 4037545 | VANDF |
| C4691680 | UMLSCUI |
| CHEBI:756410 | CHEBI |
| CHEMBL3989917 | ChEMBL_ID |
| 71544786 | PUBCHEM_CID |
| DB14019 | DRUGBANK_ID |
| CHEMBL3989919 | ChEMBL_ID |
| D11065 | KEGG_DRUG |
| 10146 | INN_ID |
| 781258008 | SNOMEDCT_US |
| 1643757-72-5 | SECONDARY_CAS_RN |
| 34267 | MMSL |
| d08869 | MMSL |
| 017511 | NDDF |
| 017512 | NDDF |
| 2044416 | RXNORM |
| T672P80L2S | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AKYNZEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 69639-102 | INJECTION | 260 mg | INTRAVENOUS | NDA | 26 sections |
| AKYNZEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 69639-105 | INJECTION | 260 mg | INTRAVENOUS | NDA | 26 sections |
| AKYNZEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 69639-106 | INJECTION | 260 mg | INTRAVENOUS | NDA | 26 sections |