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elinzanetant 🐶 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 | 5804 | 929046-33-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Elinzanetant is a non-hormonal, selective neurokinin 1 (NK-1) and 3 (NK-3) receptors antagonist. It blocks NK-1 and NK-3 receptors signalling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons, which is postulated to normalise neuronal activity involved in thermo- and sleep regulation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 24, 2025 | FDA | Bayer HealthCare Pharmaceuticals Inc. | |
| Nov. 11, 2025 | EMA | Bayer AG |
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 |
|---|---|---|---|---|---|---|
| Somnolence | 64.21 | 52.67 | 15 | 26 | 209069 | 90419337 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | G02CX07 | GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS OTHER GYNECOLOGICALS Other gynecologicals |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D064729 | Neurokinin-1 Receptor Antagonists |
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 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 60MG | LYNKUET | BAYER HLTHCARE | N219469 | Oct. 24, 2025 | RX | CAPSULE | ORAL | 10195205 | May 18, 2036 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
| 60MG | LYNKUET | BAYER HLTHCARE | N219469 | Oct. 24, 2025 | RX | CAPSULE | ORAL | 11787820 | March 13, 2039 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
| 60MG | LYNKUET | BAYER HLTHCARE | N219469 | Oct. 24, 2025 | RX | CAPSULE | ORAL | 12264164 | March 13, 2039 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE |
| 60MG | LYNKUET | BAYER HLTHCARE | N219469 | Oct. 24, 2025 | RX | CAPSULE | ORAL | 12533358 | May 14, 2045 | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE BY ADMINISTERING 60 MG (ONE CAPSULE) OF LYNKUET ORALLY ONCE DAILY AT BEDTIME CONCOMITANTLY WITH A MODERATE CYP3A4 INHIBITOR |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 60MG | LYNKUET | BAYER HLTHCARE | N219469 | Oct. 24, 2025 | RX | CAPSULE | ORAL | Oct. 24, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Substance-P receptor | GPCR | ANTAGONIST | Ki | 9.45 | DRUG LABEL | DRUG LABEL | |||
| Neuromedin-K receptor | GPCR | ANTAGONIST | Ki | 8.40 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4802157 | ChEMBL_ID |
| C000731952 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044351 | VANDF |
| C5420949 | UMLSCUI |
| CHEBI:758479 | CHEBI |
| 10952 | INN_ID |
| 16063568 | PUBCHEM_CID |
| 398946 | MMSL |
| 44500 | MMSL |
| d10333 | MMSL |
| 020208 | NDDF |
| 12691 | IUPHAR_LIGAND_ID |
| NZW2BOW35N | UNII |
| 2725511 | RXNORM |
| D12123 | KEGG_DRUG |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| LYNKUET | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50419-475 | CAPSULE | 60 mg | ORAL | NDA | 32 sections |