deflazacort 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
S (Water solubility) 0.10 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC,STK33,TEK 21
kinase-selectivity-class GRK2,MAP2K6 2
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 117.01 21.94 23 3131 1487 90623806
Angioedema 74.59 21.94 39 3115 64837 90560456
Allergy test positive 74.20 21.94 14 3140 728 90624565
Peripheral vascular disorder 56.88 21.94 17 3137 6414 90618879
Drug reaction with eosinophilia and systemic symptoms 52.85 21.94 27 3127 42731 90582562
Apraxia 48.42 21.94 12 3142 2250 90623043
Bronchiectasis 45.79 21.94 20 3134 22310 90602983
Perseveration 45.56 21.94 8 3146 277 90625016
Toxic epidermal necrolysis 41.53 21.94 21 3133 32507 90592786
Localised infection 40.90 21.94 21 3133 33541 90591752
Hyperreflexia 35.62 21.94 12 3142 6645 90618648
Skin ulcer 33.07 21.94 21 3133 50054 90575239
Bone disorder 32.68 21.94 16 3138 23104 90602189
Pseudoporphyria 32.51 21.94 6 3148 276 90625017
Staphylococcal infection 31.21 21.94 20 3134 48419 90576874
Skin discolouration 30.30 21.94 19 3135 44296 90580997
Short stature 29.70 21.94 7 3147 1063 90624230
Drug interaction 29.69 21.94 42 3112 276411 90348882
Respiratory tract infection 27.61 21.94 20 3134 59058 90566235
Tenosynovitis 26.50 21.94 12 3142 14555 90610738
Myoclonus 26.30 21.94 13 3141 19155 90606138
Muscle atrophy 25.63 21.94 10 3144 8391 90616902
Crying 25.46 21.94 14 3140 25631 90599662
Hemianopia 25.08 21.94 7 3147 2075 90623218
Paradoxical psoriasis 24.91 21.94 5 3149 359 90624934
Allodynia 24.80 21.94 6 3148 1018 90624275
Osteoporosis 24.67 21.94 23 3131 96508 90528785
Myasthenia gravis crisis 24.57 21.94 6 3148 1058 90624235
Laryngeal oedema 23.89 21.94 9 3145 6872 90618421
Syncope 23.63 21.94 26 3128 132637 90492656
Pneumonia pneumococcal 23.27 21.94 7 3147 2695 90622598
Intestinal tuberculosis 23.24 21.94 4 3150 123 90625170
Urticaria 23.08 21.94 40 3114 312694 90312599

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
No adverse event 749.59 28.31 238 4046 38783 42578268
Product dose omission issue 367.77 28.31 214 4070 154151 42462900
Intentional dose omission 363.32 28.31 98 4186 8888 42608163
Weight increased 257.06 28.31 150 4134 107833 42509218
Poor venous access 105.26 28.31 36 4248 7216 42609835
Influenza 103.42 28.31 69 4215 62106 42554945
Myoglobinuria 101.51 28.31 22 4262 781 42616270
Nasopharyngitis 82.72 28.31 68 4216 83928 42533123
Gastroenteritis viral 82.38 28.31 31 4253 8168 42608883
Increased appetite 72.85 28.31 29 4255 8877 42608174
Device issue 70.58 28.31 32 4252 13477 42603574
Cushingoid 65.74 28.31 21 4263 3401 42613650
Growth retardation 55.39 28.31 17 4267 2415 42614636
Femur fracture 50.48 28.31 23 4261 9789 42607262
Anger 47.19 28.31 24 4260 12994 42604057
Systemic inflammatory response syndrome 43.38 28.31 19 4265 7371 42609680
Osteoporosis 41.37 28.31 23 4261 14883 42602168
Behaviour disorder 40.96 28.31 18 4266 7036 42610015
Off label use 39.85 28.31 147 4137 638188 41978863
Fall 36.87 28.31 76 4208 234444 42382607
Lower limb fracture 33.19 28.31 14 4270 4953 42612098
Swelling face 32.83 28.31 25 4259 27529 42589522
Tachypnoea 31.11 28.31 22 4262 21640 42595411
Mucocutaneous leishmaniasis 31.03 28.31 6 4278 119 42616932
Inflammation 30.34 28.31 26 4258 33821 42583230
Rhabdomyolysis 29.92 28.31 38 4246 77981 42539070
Face oedema 29.72 28.31 18 4266 13648 42603403
Abnormal behaviour 29.33 28.31 23 4261 26428 42590623
Product distribution issue 29.31 28.31 10 4274 1984 42615067
Malaise 28.99 28.31 65 4219 212091 42404960
Leishmaniasis 28.41 28.31 7 4277 439 42616612

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
No adverse event 719.93 19.55 229 5413 73610 110510047
Intentional dose omission 341.69 19.55 96 5546 19984 110563673
Product dose omission issue 269.86 19.55 180 5462 321602 110262055
Myoglobinuria 107.05 19.55 22 5620 1206 110582451
Poor venous access 82.95 19.55 35 5607 24487 110559170
Allergy test positive 65.79 19.55 14 5628 909 110582748
Device issue 62.62 19.55 32 5610 34503 110549154
Face oedema 57.76 19.55 30 5612 33439 110550218
Systemic inflammatory response syndrome 52.19 19.55 21 5621 13022 110570635
Bursitis infective 48.94 19.55 12 5630 1464 110582193
Drug reaction with eosinophilia and systemic symptoms 41.47 19.55 34 5608 82061 110501596
Rhabdomyolysis 41.19 19.55 40 5602 120361 110463296
Toxic epidermal necrolysis 40.79 19.55 29 5613 56698 110526959
Perseveration 39.28 19.55 8 5634 419 110583238
Apraxia 38.55 19.55 12 5630 3528 110580129
Angioedema 38.04 19.55 35 5607 98465 110485192
Tachypnoea 32.69 19.55 22 5620 39373 110544284
Leishmaniasis 32.21 19.55 7 5635 502 110583155
Pyrexia 30.76 19.55 108 5534 898157 109685500
Osteoporosis 29.88 19.55 29 5613 87123 110496534
Product distribution issue 28.32 19.55 10 5632 4336 110579321
Hyperreflexia 27.03 19.55 12 5630 9473 110574184
Mucocutaneous leishmaniasis 26.43 19.55 6 5636 525 110583132
Delayed puberty 25.69 19.55 5 5637 207 110583450
Influenza 25.57 19.55 37 5605 169064 110414593
Growth retardation 24.99 19.55 8 5634 2574 110581083
Bone development abnormal 24.03 19.55 4 5638 67 110583590
Pseudoporphyria 23.97 19.55 6 5636 797 110582860
Abnormal behaviour 23.64 19.55 18 5624 39021 110544636
Pneumonia pneumococcal 23.39 19.55 9 5633 4956 110578701
Pulmonary hilum mass 22.58 19.55 5 5637 391 110583266
Weight increased 22.34 19.55 59 5583 419585 110164072
Increased appetite 21.82 19.55 12 5630 14965 110568692
Femur fracture 21.57 19.55 18 5624 44451 110539206
Paradoxical psoriasis 21.14 19.55 5 5637 524 110583133
Hemianopia 20.23 19.55 7 5635 2861 110580796
Hypokinesia 20.07 19.55 13 5629 21813 110561844

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
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

H02AB Glucocorticoids 15 drugs
betamethasonecloprednolcortivazoldexamethasonefluocortolonehydrocortisonemeprednisonemethylprednisoloneparamethasone acetateprednisoloneprednisoneprednylidene show all 15 →

Drug Use | Suggest Off label Use Form| |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 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
9477 IUPHAR_LIGAND_ID
C014725 MESH_SUPPLEMENTAL_RECORD_UI
4323 INN_ID
KR5YZ6AE4B UNII
189821 PUBCHEM_CID
164824 MMSL
18036 MMSL
194846 MMSL
d04977 MMSL
006032 NDDF
116578002 SNOMEDCT_US
396012006 SNOMEDCT_US
C0244919 UMLSCUI
CHEMBL5315131 ChEMBL_ID
13649-57-5 SECONDARY_CAS_RN
3081431 PUBCHEM_CID
T1LWN33J2P UNII
CHEBI:759806 CHEBI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KYMBEE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0813 SUSPENSION 22.75 mg ORAL ANDA 31 sections
KYMBEE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0814 TABLET 6 mg ORAL ANDA 30 sections
KYMBEE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0815 TABLET 18 mg ORAL ANDA 30 sections
KYMBEE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0816 TABLET 30 mg ORAL ANDA 30 sections
KYMBEE HUMAN PRESCRIPTION DRUG LABEL 1 0245-0817 TABLET 36 mg ORAL ANDA 30 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 0832-0814 TABLET 6 mg ORAL ANDA 30 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 0832-0815 TABLET 18 mg ORAL ANDA 30 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 0832-0816 TABLET 30 mg ORAL ANDA 30 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 0832-0817 TABLET 36 mg ORAL ANDA 30 sections
Deflazacort Oral Suspension HUMAN PRESCRIPTION DRUG LABEL 1 27808-249 SUSPENSION 22.75 mg ORAL ANDA 25 sections
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
Deflazacort Oral Suspension HUMAN PRESCRIPTION DRUG LABEL 1 57664-993 SUSPENSION 22.75 mg ORAL ANDA 26 sections
Deflazacort Human Prescription Drug Label 1 59651-599 TABLET 6 mg ORAL ANDA 24 sections
Deflazacort Human Prescription Drug Label 1 59651-600 TABLET 18 mg ORAL ANDA 24 sections
Deflazacort Human Prescription Drug Label 1 59651-601 TABLET 30 mg ORAL ANDA 24 sections
Deflazacort Human Prescription Drug Label 1 59651-602 TABLET 36 mg ORAL ANDA 24 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 60219-2282 TABLET 6 mg ORAL ANDA 24 sections
DEFLAZACORT HUMAN PRESCRIPTION DRUG LABEL 1 60219-2283 TABLET 18 mg ORAL ANDA 24 sections
DEFLAZACORT HUMAN PRESCRIPTION DRUG LABEL 1 60219-2284 TABLET 30 mg ORAL ANDA 24 sections
DEFLAZACORT HUMAN PRESCRIPTION DRUG LABEL 1 60219-2285 TABLET 36 mg ORAL ANDA 24 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 70095-040 TABLET 6 mg ORAL ANDA 18 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 70095-041 TABLET 18 mg ORAL ANDA 18 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 70095-042 TABLET 30 mg ORAL ANDA 18 sections
Deflazacort HUMAN PRESCRIPTION DRUG LABEL 1 70095-043 TABLET 36 mg ORAL ANDA 18 sections
JAYTHARI HUMAN PRESCRIPTION DRUG LABEL 1 70710-1749 TABLET 6 mg ORAL ANDA 23 sections
JAYTHARI HUMAN PRESCRIPTION DRUG LABEL 1 70710-1750 TABLET 18 mg ORAL ANDA 23 sections