deflazacort 🐶 Veterinary Use | 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: OFP

  • 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
Bursitis infective 111.52 23.24 23 2716 1211 50601174
Angioedema 75.43 23.24 38 2701 37638 50564747
Allergy test positive 70.06 23.24 13 2726 392 50601993
Bronchiectasis 52.26 23.24 20 2719 10263 50592122
Peripheral vascular disorder 52.21 23.24 17 2722 5450 50596935
Drug reaction with eosinophilia and systemic symptoms 49.16 23.24 26 2713 28398 50573987
Apraxia 47.71 23.24 12 2727 1533 50600852
Perseveration 42.68 23.24 8 2731 255 50602130
Localised infection 37.63 23.24 21 2718 25464 50576921
Urticaria 36.86 23.24 40 2699 129521 50472864
Toxic epidermal necrolysis 35.71 23.24 19 2720 20973 50581412
Hyperreflexia 33.53 23.24 12 2727 5106 50597279
Skin ulcer 31.31 23.24 21 2718 35297 50567088
Osteoporosis 31.21 23.24 23 2716 44856 50557529
Respiratory tract infection 30.71 23.24 20 2719 31997 50570388
Skin discolouration 30.30 23.24 20 2719 32737 50569648
Bone disorder 29.18 23.24 16 2723 18736 50583649
Staphylococcal infection 28.78 23.24 20 2719 35596 50566789
Hemianopia 27.97 23.24 7 2732 875 50601510
Paradoxical psoriasis 27.30 23.24 5 2734 140 50602245
Tenosynovitis 25.12 23.24 12 2727 10553 50591832
Allodynia 24.50 23.24 6 2733 686 50601699
Myoclonus 24.33 23.24 13 2726 14457 50587928

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 287.06 40.03 138 2495 76529 29495365
Myoglobinuria 106.48 40.03 22 2611 702 29571192
Nasopharyngitis 106.32 40.03 66 2567 59599 29512295
Influenza 105.47 40.03 58 2575 41823 29530071
Product dose omission issue 92.67 40.03 73 2560 96310 29475584
Gastroenteritis viral 80.61 40.03 27 2606 5745 29566149
Increased appetite 75.40 40.03 26 2607 6038 29565856
Off label use 66.43 40.03 105 2528 300695 29271199
Intentional dose omission 51.24 40.03 15 2618 2051 29569843
Anger 50.89 40.03 23 2610 10867 29561027
Behaviour disorder 50.81 40.03 17 2616 3599 29568295
Systemic inflammatory response syndrome 49.52 40.03 19 2614 5962 29565932
Cushingoid 48.79 40.03 15 2618 2423 29569471
No adverse event 46.08 40.03 25 2608 17453 29554441
Fall 43.28 40.03 65 2568 177113 29394781
Growth retardation 41.11 40.03 12 2621 1624 29570270
Poor venous access 41.02 40.03 14 2619 3147 29568747

FDA Adverse Event Reporting System (Geriatric)

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
Myoglobinuria 109.13 21.30 22 3657 978 64494075
Allergy test positive 68.42 21.30 13 3666 423 64494630
Systemic inflammatory response syndrome 54.88 21.30 21 3658 10214 64484839
Bursitis infective 50.09 21.30 12 3667 1188 64493865
Angioedema 46.70 21.30 34 3645 61787 64433266
Drug reaction with eosinophilia and systemic symptoms 43.65 21.30 31 3648 54186 64440867
Apraxia 41.38 21.30 12 3667 2483 64492570
Toxic epidermal necrolysis 41.37 21.30 26 3653 37140 64457913
No adverse event 39.58 21.30 23 3656 28538 64466515
Perseveration 39.28 21.30 8 3671 374 64494679
Intentional dose omission 39.14 21.30 14 3665 5638 64489415
Pyrexia 38.99 21.30 93 3586 558551 63936502
Weight increased 38.87 21.30 54 3625 213294 64281759
Tachypnoea 35.77 21.30 21 3658 26550 64468503
Inflammation 34.33 21.30 29 3650 65271 64429782
Product dose omission issue 33.54 21.30 48 3631 194699 64300354
Rhabdomyolysis 33.11 21.30 33 3646 91693 64403360
Hyperreflexia 29.01 21.30 12 3667 7136 64487917
Poor venous access 28.51 21.30 14 3665 12403 64482650
Paradoxical psoriasis 26.97 21.30 5 3674 142 64494911
Delayed puberty 26.73 21.30 5 3674 149 64494904
Bone development abnormal 25.24 21.30 4 3675 43 64495010
Face oedema 24.28 21.30 16 3663 24745 64470308
Hemianopia 23.75 21.30 7 3672 1532 64493521
Hypophosphataemia 23.48 21.30 13 3666 14707 64480346
Urticaria 23.44 21.30 35 3644 147282 64347771
Fall 22.38 21.30 63 3616 416763 64078290

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Duchenne muscular dystrophy indication 76670001 DOID:11723




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
D03671 KEGG_DRUG
153100 RXNORM
4036431 VANDF
C0057258 UMLSCUI
CHEBI:135720 CHEBI
CHEMBL1201891 ChEMBL_ID
DB11921 DRUGBANK_ID
C021988 MESH_SUPPLEMENTAL_RECORD_UI
C014725 MESH_SUPPLEMENTAL_RECORD_UI
9477 IUPHAR_LIGAND_ID
4323 INN_ID
13649-57-5 SECONDARY_CAS_RN
KR5YZ6AE4B UNII
189821 PUBCHEM_CID
3081431 PUBCHEM_CID
18036 MMSL
d04977 MMSL
006032 NDDF
116578002 SNOMEDCT_US
396012006 SNOMEDCT_US
C0244919 UMLSCUI
T1LWN33J2P UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-501 TABLET 6 mg ORAL NDA 27 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-502 TABLET 18 mg ORAL NDA 27 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-503 TABLET 30 mg ORAL NDA 27 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-504 TABLET 36 mg ORAL NDA 27 sections
EMFLAZA HUMAN PRESCRIPTION DRUG LABEL 1 52856-505 SUSPENSION 22.75 mg ORAL NDA 27 sections