deflazacort Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 793 14484-47-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • deflazacort
  • azacort
  • azacortinol
  • calcort
  • dezacor
  • dezacort
  • flantadin
  • lantadin
  • oxazacort
Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with Duchenne muscular dystrophy is unknown.
  • Molecular weight: 441.52
  • Formula: C25H31NO6
  • CLOGP: 2.86
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 102.26
  • ALOGS: -4.40
  • ROTB: 4

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
15 mg O

ADMET properties:

PropertyValueReference
BA (Bioavailability) 68 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Feb. 9, 2017 FDA MARATHON PHARMACEUTICALS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Angioedema 145.42 118.33 28 103 8368 2349586

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Weight increased 525.36 68.01 133 798 11224 1734626
Nasopharyngitis 211.93 68.01 64 867 9946 1735904
Influenza 194.90 68.01 55 876 6712 1739138
Off label use 187.44 68.01 83 848 38488 1707362
Increased appetite 128.27 68.01 27 904 944 1744906
Gastroenteritis viral 121.82 68.01 26 905 972 1744878
Fall 110.68 68.01 52 879 27162 1718688
Behaviour disorder 94.57 68.01 16 915 163 1745687
Anger 82.46 68.01 23 908 2643 1743207
Abdominal pain upper 80.73 68.01 32 899 10969 1734881
Swelling face 74.76 68.01 24 907 4459 1741391
Product dose omission 73.28 68.01 37 894 22403 1723447

Pharmacologic Action:

SourceCodeDescription
ATC H02AB13 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
CORTICOSTEROIDS FOR SYSTEMIC USE
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
Glucocorticoids
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Duchenne muscular dystrophy indication 76670001 DOID:11723

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.27 acidic
pKa2 7.14 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
18MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2022 NEW CHEMICAL ENTITY
30MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2022 NEW CHEMICAL ENTITY
36MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2022 NEW CHEMICAL ENTITY
6MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2022 NEW CHEMICAL ENTITY
22.75MG/ML EMFLAZA PTC THERAP N208685 Feb. 9, 2017 RX SUSPENSION ORAL Feb. 9, 2022 NEW CHEMICAL ENTITY
18MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2024 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
30MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2024 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
36MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2024 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
6MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL Feb. 9, 2024 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
22.75MG/ML EMFLAZA PTC THERAP N208685 Feb. 9, 2017 RX SUSPENSION ORAL Feb. 9, 2024 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS 5 YEARS OF AGE AND OLDER
18MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL June 7, 2026 TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
30MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL June 7, 2026 TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
36MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL June 7, 2026 TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
6MG EMFLAZA PTC THERAP N208684 Feb. 9, 2017 RX TABLET ORAL June 7, 2026 TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE
22.75MG/ML EMFLAZA PTC THERAP N208685 Feb. 9, 2017 RX SUSPENSION ORAL June 7, 2026 TREATMENT OF DUCHENE MUSCULAR DYSTROPHY IN PATIENTS 2 YEARS OF AGE TO LESS THAN 5 YEARS OF AGE

Bioactivity Summary:

None

External reference:

IDSource
C0057258 UMLSCUI
D03671 KEGG_DRUG
116578002 SNOMEDCT_US
22396 RXNORM
396012006 SNOMEDCT_US
006032 NDDF
4036431 VANDF
18036 MMSL
d04977 MMSL
C014725 MESH_SUPPLEMENTAL_RECORD_UI
KR5YZ6AE4B UNII
4323 INN_ID
13649-57-5 SECONDARY_CAS_RN
DB11921 DRUGBANK_ID
CHEBI:135720 CHEBI
9477 IUPHAR_LIGAND_ID
CHEMBL1201891 ChEMBL_ID
189821 PUBCHEM_CID
C021988 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 42998-501 TABLET 6 mg ORAL NDA 17 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 42998-502 TABLET 18 mg ORAL NDA 17 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 42998-503 TABLET 30 mg ORAL NDA 17 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 42998-504 TABLET 36 mg ORAL NDA 17 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 42998-505 SUSPENSION 22.75 mg ORAL NDA 17 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-501 TABLET 6 mg ORAL NDA 18 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-502 TABLET 18 mg ORAL NDA 18 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-503 TABLET 30 mg ORAL NDA 18 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-504 TABLET 36 mg ORAL NDA 18 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-505 SUSPENSION 22.75 mg ORAL NDA 18 sections