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netupitant 🐶 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 | 4898 | 290297-26-6 |
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 |
|---|---|---|
| Vd (Volume of distribution) | 5.54 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.83 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.00 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 34.28 hours | Lombardo F, Berellini G, Obach RS |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,BRAF,EIF2AK3,GRK2,PDK2,PDK4,PRKDC | 7 | |||
| kinase-selectivity-class | PDK4 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 10, 2014 | FDA | HELSINN HLTHCARE | |
| May 27, 2015 | EMA | Helsinn Birex Pharmaceuticals 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 |
|---|---|---|---|---|---|---|
| Neutropenia | 61.70 | 39.65 | 40 | 1360 | 224864 | 90402183 |
| Dysgeusia | 48.27 | 39.65 | 21 | 1379 | 52539 | 90574508 |
| Febrile neutropenia | 47.92 | 39.65 | 30 | 1370 | 158319 | 90468728 |
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 |
|---|---|---|---|---|---|---|
| Subclavian artery occlusion | 40.33 | 39.81 | 6 | 897 | 120 | 42620312 |
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 |
|---|---|---|---|---|---|---|
| Neutropenia | 67.48 | 34.97 | 59 | 2301 | 374561 | 110212378 |
| Febrile neutropenia | 51.25 | 34.97 | 47 | 2313 | 316720 | 110270219 |
| Hypomagnesaemia | 50.55 | 34.97 | 25 | 2335 | 60345 | 110526594 |
| Anaemia | 50.39 | 34.97 | 60 | 2300 | 547026 | 110039913 |
| Dysgeusia | 41.48 | 34.97 | 23 | 2337 | 69962 | 110516977 |
| Decreased appetite | 40.20 | 34.97 | 50 | 2310 | 475796 | 110111143 |
| Asthenia | 39.52 | 34.97 | 60 | 2300 | 688939 | 109898000 |
| Subclavian artery occlusion | 38.37 | 34.97 | 6 | 2354 | 167 | 110586772 |
| Flushing | 35.31 | 34.97 | 24 | 2336 | 104712 | 110482227 |
| Hypokalaemia | 35.30 | 34.97 | 30 | 2330 | 182418 | 110404521 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000010262 | Neurokinin 1 Antagonists |
| FDA EPC | N0000175786 | Substance P/Neurokinin-1 Receptor Antagonist |
| FDA MoA | N0000182141 | Cytochrome P450 3A4 Inhibitors |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50919 | antiemetic |
| CHEBI has role | CHEBI:55350 | neurokinin-1 receptor antagonist |
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 | 8.9 | Basic |
| pKa2 | 3.35 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 11559523 | Nov. 18, 2030 | METHOD OF TREATING EMESIS |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 12042494 | Nov. 18, 2030 | METHOD OF TREATING EMESIS |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 8623826 | 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 CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 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 CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 9943515 | 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 CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 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 CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC CHEMOTHERAPY |
| 300MG;EQ 0.5MG BASE | AKYNZEO | HELSINN HLTHCARE | N205718 | Oct. 10, 2014 | RX | CAPSULE | ORAL | 9271975 | Sept. 9, 2031 | USE IN COMBINATION WITH DEXAMETHASONE IN ADULTS FOR THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF CANCER CHEMOTHERAPY, INCLUDING, BUT NOT LIMITED TO, HIGHLY EMETOGENIC 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 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| 7732P08TIR | UNII |
| D05152 | KEGG_DRUG |
| 4033795 | VUID |
| N0000191094 | NUI |
| 4033795 | VANDF |
| C1700730 | UMLSCUI |
| CHEBI:85155 | CHEBI |
| CHEMBL206253 | ChEMBL_ID |
| 6451149 | PUBCHEM_CID |
| DB09048 | DRUGBANK_ID |
| 8409 | INN_ID |
| C508854 | MESH_SUPPLEMENTAL_RECORD_UI |
| 5742 | IUPHAR_LIGAND_ID |
| 1552337 | RXNORM |
| 30612 | MMSL |
| d08299 | MMSL |
| 015714 | NDDF |
| 1296945000 | SNOMEDCT_US |
| 716123009 | SNOMEDCT_US |
| GAW | PDB_CHEM_ID |
| 7732P08TIR | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| AKYNZEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 69639-101 | CAPSULE | 300 mg | ORAL | NDA | 26 sections |