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daridorexant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| orexin receptor antagonists | 5493 | 1505484-82-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,EIF2AK3,ERBB2,GRK2,PDK1,PDK2,PDK4,PRKDC | 10 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 1, 2022 | FDA | IDORSIA PHARMACEUTICALS LTD | |
| April 29, 2022 | EMA | IDORSIA PHARMACEUTICALS DEUTSCHLAND GMBH |
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 |
|---|---|---|---|---|---|---|
| Nightmare | 144.92 | 43.39 | 34 | 722 | 21691 | 90606000 |
| Sleep paralysis | 69.30 | 43.39 | 11 | 745 | 887 | 90626804 |
| Suicidal ideation | 61.21 | 43.39 | 23 | 733 | 73832 | 90553859 |
| Abnormal dreams | 56.29 | 43.39 | 14 | 742 | 11243 | 90616448 |
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 |
|---|---|---|---|---|---|---|
| Nightmare | 71.60 | 57.74 | 20 | 343 | 24992 | 42595980 |
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 |
|---|---|---|---|---|---|---|
| Nightmare | 124.88 | 35.36 | 35 | 1027 | 38828 | 110549409 |
| Suicidal ideation | 87.18 | 35.36 | 33 | 1029 | 93904 | 110494333 |
| Sleep paralysis | 81.94 | 35.36 | 13 | 1049 | 905 | 110587332 |
| Somnolence | 36.78 | 35.36 | 27 | 1035 | 297422 | 110290815 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05CJ03 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Orexin receptor antagonists |
| FDA MoA | N0000190998 | Orexin Receptor Antagonists |
| FDA EPC | N0000191000 | Orexin Receptor Antagonist |
| CHEBI has role | CHEBI:35469 | antidepressant |
Related Drugs by ATC class:
N05CJ Orexin receptor antagonists 2 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Insomnia | indication | 193462001 | |
| Narcolepsy | contraindication | 60380001 | DOID:8986 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 9732075 | June 12, 2033 | TREATMENT OF INSOMNIA |
| EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 9732075 | June 12, 2033 | TREATMENT OF INSOMNIA |
| EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 10023560 | Dec. 2, 2034 | TREATMENT OF INSOMNIA |
| EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | 10023560 | Dec. 2, 2034 | TREATMENT OF INSOMNIA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | April 7, 2027 | NEW CHEMICAL ENTITY |
| EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | April 7, 2027 | NEW CHEMICAL ENTITY |
| EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | Sept. 30, 2027 | CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING. |
| EQ 25MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | Sept. 30, 2027 | REVISIONS TO THE CLINICAL STUDIES SECTION TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST-MARKETING REQUIREMENT 4150-1 |
| EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | Sept. 30, 2027 | CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING. |
| EQ 50MG BASE | QUVIVIQ | IDORSIA | N214985 | April 7, 2022 | RX | TABLET | ORAL | Sept. 30, 2027 | REVISIONS TO THE CLINICAL STUDIES SECTION TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST-MARKETING REQUIREMENT 4150-1 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Orexin receptor type 1 | GPCR | ANTAGONIST | Ki | 9.33 | DRUG LABEL | ||||
| Orexin receptor type 2 | GPCR | ANTAGONIST | Ki | 9.03 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEBI:757065 | CHEBI |
| CHEMBL4297590 | ChEMBL_ID |
| C000634383 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11648 | IUPHAR_LIGAND_ID |
| DB15031 | DRUGBANK_ID |
| 4041355 | VANDF |
| C5227711 | UMLSCUI |
| D11886 | KEGG_DRUG |
| NS2 | PDB_CHEM_ID |
| CHEMBL4650216 | ChEMBL_ID |
| 10679 | INN_ID |
| 1792993-84-0 | SECONDARY_CAS_RN |
| 91801202 | PUBCHEM_CID |
| 358453 | MMSL |
| 40618 | MMSL |
| d09879 | MMSL |
| 018928 | NDDF |
| 018929 | NDDF |
| LMQ24G57E9 | UNII |
| 2591496 | RXNORM |
| LMQ24G57E9 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 36 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 36 sections |