daridorexant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
orexin receptor antagonists 5493 1505484-82-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • daridorexant
  • quviviq
  • daridorexant hydrochloride
  • ACT-541468
  • nemorexant
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.
  • Molecular weight: 450.93
  • Formula: C23H23ClN6O2
  • CLOGP: 5.19
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 88.93
  • ALOGS: -4.61
  • ROTB: 4

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 1, 2022 FDA IDORSIA PHARMACEUTICALS LTD

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA MoA N0000190998 Orexin Receptor Antagonists
FDA EPC N0000191000 Orexin Receptor Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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:

IDSource
NS2 PDB_CHEM_ID
CHEMBL4297590 ChEMBL_ID
C000634383 MESH_SUPPLEMENTAL_RECORD_UI
11648 IUPHAR_LIGAND_ID
10679 INN_ID
1792993-84-0 SECONDARY_CAS_RN
LMQ24G57E9 UNII
91801202 PUBCHEM_CID
DB15031 DRUGBANK_ID
2591496 RXNORM
4041355 VANDF
D11886 KEGG_DRUG
C5227711 UMLSCUI
CHEMBL4650216 ChEMBL_ID
018928 NDDF
018929 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
QUVIVIQ HUMAN PRESCRIPTION DRUG LABEL 1 80491-7825 TABLET, FILM COATED 25 mg ORAL NDA 34 sections
QUVIVIQ HUMAN PRESCRIPTION DRUG LABEL 1 80491-7850 TABLET, FILM COATED 50 mg ORAL NDA 34 sections