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fezolinetant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| neurokinin NK3 and dual NK3-NK1 receptor antagonists | 5729 | 1629229-37-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Fezolinetant is a neurokinin 3 (NK3) receptor antagonist that blocks neurokinin B (NKB) binding on the kisspeptin/neurokinin B/dynorphin (KNDy) neuron to modulate neuronal activity in the thermoregulatory center. Fezolinetant has high affinity for the NK3 receptor (Ki value of 19.9 to 22.1 nmol/L), which is more than 450-fold higher than binding affinity to NK1 or NK2 receptors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 45 | mg | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,EIF2AK3,GRK2,PDK1,PDK2,PDK4,PRKDC | 7 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 12, 2023 | FDA | ASTELLAS |
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 |
|---|---|---|---|---|---|---|
| Alanine aminotransferase increased | 478.53 | 47.13 | 141 | 1280 | 118197 | 90508829 |
| Aspartate aminotransferase increased | 321.96 | 47.13 | 101 | 1320 | 102836 | 90524190 |
| Hepatic enzyme increased | 216.96 | 47.13 | 107 | 1314 | 360629 | 90266397 |
| Liver function test increased | 163.42 | 47.13 | 58 | 1363 | 84797 | 90542229 |
| Gamma-glutamyltransferase increased | 112.73 | 47.13 | 36 | 1385 | 37916 | 90589110 |
| Drug ineffective | 84.76 | 47.13 | 105 | 1316 | 1384193 | 89242833 |
| Transaminases increased | 69.75 | 47.13 | 25 | 1396 | 37167 | 90589859 |
| Blood alkaline phosphatase increased | 60 | 47.13 | 24 | 1397 | 48055 | 90578971 |
| Hot flush | 55.07 | 47.13 | 24 | 1397 | 59464 | 90567562 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Alanine aminotransferase increased | 305.04 | 52.91 | 91 | 669 | 183682 | 110404857 |
| Aspartate aminotransferase increased | 229.36 | 52.91 | 71 | 689 | 159865 | 110428674 |
| Gamma-glutamyltransferase increased | 73.81 | 52.91 | 24 | 736 | 61285 | 110527254 |
| Blood alkaline phosphatase increased | 55.03 | 52.91 | 20 | 740 | 70915 | 110517624 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G02CX06 | GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS OTHER GYNECOLOGICALS Other gynecologicals |
| FDA EPC | N0000194090 | Neurokinin 3 Receptor Antagonist |
| FDA MoA | N0000194091 | Neurokinin 3 Receptor Antagonists |
| CHEBI has role | CHEBI:140482 | neurokinin-3 receptor antagonist |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
G02CX Other gynecologicals 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Vasomotor symptoms due to menopause | indication | 123756000 | |
| Cirrhosis of liver | contraindication | 19943007 | DOID:5082 |
| End stage renal disease | contraindication | 46177005 | DOID:784 |
| Renal impairment | contraindication | 236423003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 45MG | VEOZAH | ASTELLAS | N216578 | May 12, 2023 | RX | TABLET | ORAL | 10836768 | March 28, 2034 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
| 45MG | VEOZAH | ASTELLAS | N216578 | May 12, 2023 | RX | TABLET | ORAL | 9422299 | March 28, 2034 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
| 45MG | VEOZAH | ASTELLAS | N216578 | May 12, 2023 | RX | TABLET | ORAL | 9987274 | March 28, 2034 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 45MG | VEOZAH | ASTELLAS | N216578 | May 12, 2023 | RX | TABLET | ORAL | May 12, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Neuromedin-K receptor | GPCR | ANTAGONIST | Ki | 7.60 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 4.16 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| CHEBI:229236 | CHEBI |
| CHEMBL3608680 | ChEMBL_ID |
| C000608808 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10422 | IUPHAR_LIGAND_ID |
| DB15669 | DRUGBANK_ID |
| 4042266 | VANDF |
| C4547455 | UMLSCUI |
| 10205 | INN_ID |
| 117604931 | PUBCHEM_CID |
| 367097 | MMSL |
| 41521 | MMSL |
| d10045 | MMSL |
| 019428 | NDDF |
| D11976 | KEGG_DRUG |
| 83VNE45KXX | UNII |
| 2637134 | RXNORM |
| 83VNE45KXX | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VEOZAH | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-2460 | TABLET, FILM COATED | 45 mg | ORAL | NDA | 29 sections |
| VEOZAH | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-2660 | TABLET, FILM COATED | 45 mg | ORAL | NDA | 29 sections |
| VEOZAH | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0469-2760 | TABLET, FILM COATED | 45 mg | ORAL | NDA | 29 sections |