daridorexant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 29, 2022 | EMA | IDORSIA PHARMACEUTICALS DEUTSCHLAND GMBH | |
| Jan. 1, 2022 | FDA | IDORSIA 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 |
|---|---|---|---|---|---|---|
| Nightmare | 118.60 | 74.28 | 20 | 55 | 19174 | 63469773 |
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 |
|---|---|---|---|---|---|---|
| Nightmare | 112.71 | 97.08 | 19 | 48 | 25842 | 79718479 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000190998 | Orexin Receptor Antagonists |
| FDA EPC | N0000191000 | Orexin Receptor Antagonist |
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 |
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 |
|---|---|
| NS2 | PDB_CHEM_ID |
| CHEMBL4297590 | ChEMBL_ID |
| C000634383 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11648 | IUPHAR_LIGAND_ID |
| 1792993-84-0 | SECONDARY_CAS_RN |
| DB15031 | DRUGBANK_ID |
| 018928 | NDDF |
| 018929 | NDDF |
| 4041355 | VANDF |
| D11886 | KEGG_DRUG |
| C5227711 | UMLSCUI |
| CHEMBL4650216 | ChEMBL_ID |
| 10679 | INN_ID |
| 91801202 | PUBCHEM_CID |
| 2591496 | RXNORM |
| 358453 | MMSL |
| 40618 | MMSL |
| d09879 | MMSL |
| LMQ24G57E9 | UNII |
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 | 35 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 35 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7825 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 35 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |
| QUVIVIQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80491-7850 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 35 sections |