deflazacort 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| corticosteroids, except prednisolone derivatives | 793 | 14484-47-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 15 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 9, 2017 | FDA | MARATHON PHARMACEUTICALS LLC |
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 |
|---|---|---|---|---|---|---|
| Bursitis infective | 113.17 | 21.03 | 23 | 2915 | 1320 | 63484764 |
| Angioedema | 78.13 | 21.03 | 40 | 2898 | 47925 | 63438159 |
| Allergy test positive | 72.73 | 21.03 | 14 | 2924 | 606 | 63485478 |
| Drug reaction with eosinophilia and systemic symptoms | 54.43 | 21.03 | 28 | 2910 | 33808 | 63452276 |
| Peripheral vascular disorder | 53.18 | 21.03 | 17 | 2921 | 6018 | 63480066 |
| Apraxia | 47.61 | 21.03 | 12 | 2926 | 1809 | 63484275 |
| Bronchiectasis | 46.56 | 21.03 | 20 | 2918 | 16122 | 63469962 |
| Perseveration | 43.57 | 21.03 | 8 | 2930 | 267 | 63485817 |
| Localised infection | 37.36 | 21.03 | 21 | 2917 | 30189 | 63455895 |
| Urticaria | 37.28 | 21.03 | 42 | 2896 | 165760 | 63320324 |
| Toxic epidermal necrolysis | 35.15 | 21.03 | 19 | 2919 | 25315 | 63460769 |
| Hyperreflexia | 33.63 | 21.03 | 12 | 2926 | 5922 | 63480162 |
| Pseudoporphyria | 32.54 | 21.03 | 6 | 2932 | 205 | 63485879 |
| Skin discolouration | 30.52 | 21.03 | 20 | 2918 | 37808 | 63448276 |
| Skin ulcer | 30.52 | 21.03 | 21 | 2917 | 43024 | 63443060 |
| Bone disorder | 29.60 | 21.03 | 16 | 2922 | 21310 | 63464774 |
| Osteoporosis | 29.40 | 21.03 | 23 | 2915 | 57315 | 63428769 |
| Staphylococcal infection | 28.95 | 21.03 | 20 | 2918 | 41236 | 63444848 |
| Respiratory tract infection | 28.85 | 21.03 | 20 | 2918 | 41463 | 63444621 |
| Hemianopia | 27.48 | 21.03 | 7 | 2931 | 1100 | 63484984 |
| Paradoxical psoriasis | 25.65 | 21.03 | 5 | 2933 | 231 | 63485853 |
| Drug interaction | 25.21 | 21.03 | 41 | 2897 | 229090 | 63256994 |
| Myoclonus | 25.12 | 21.03 | 13 | 2925 | 15855 | 63470229 |
| Allodynia | 24.43 | 21.03 | 6 | 2932 | 813 | 63485271 |
| Tenosynovitis | 23.87 | 21.03 | 12 | 2926 | 13783 | 63472301 |
| Crying | 22.98 | 21.03 | 14 | 2924 | 23329 | 63462755 |
| Pneumonia pneumococcal | 22.68 | 21.03 | 7 | 2931 | 2208 | 63483876 |
| Muscle atrophy | 21.22 | 21.03 | 9 | 2929 | 7024 | 63479060 |
FDA Adverse Event Reporting System (Male)
| 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 |
|---|---|---|---|---|---|---|
| Weight increased | 271.03 | 35.71 | 141 | 2944 | 92892 | 34860954 |
| No adverse event | 188.00 | 35.71 | 72 | 3013 | 22855 | 34930991 |
| Product dose omission issue | 150.49 | 35.71 | 106 | 2979 | 119605 | 34834241 |
| Intentional dose omission | 116.97 | 35.71 | 32 | 3053 | 3468 | 34950378 |
| Myoglobinuria | 104.80 | 35.71 | 22 | 3063 | 766 | 34953080 |
| Influenza | 104.53 | 35.71 | 61 | 3024 | 49605 | 34904241 |
| Nasopharyngitis | 97.13 | 35.71 | 66 | 3019 | 69902 | 34883944 |
| Gastroenteritis viral | 79.05 | 35.71 | 28 | 3057 | 7096 | 34946750 |
| Increased appetite | 74.16 | 35.71 | 27 | 3058 | 7402 | 34946444 |
| Off label use | 60.48 | 35.71 | 121 | 2964 | 419403 | 34534443 |
| Poor venous access | 56.08 | 35.71 | 20 | 3065 | 5163 | 34948683 |
| Anger | 49.15 | 35.71 | 23 | 3062 | 11861 | 34941985 |
| Systemic inflammatory response syndrome | 47.55 | 35.71 | 19 | 3066 | 6690 | 34947156 |
| Cushingoid | 47.33 | 35.71 | 15 | 3070 | 2699 | 34951147 |
| Behaviour disorder | 45.86 | 35.71 | 17 | 3068 | 4893 | 34948953 |
| Swelling face | 39.79 | 35.71 | 25 | 3060 | 23080 | 34930766 |
| Growth retardation | 39.77 | 35.71 | 12 | 3073 | 1836 | 34952010 |
| Fall | 39.71 | 35.71 | 67 | 3018 | 202818 | 34751028 |
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 |
|---|---|---|---|---|---|---|
| No adverse event | 181.10 | 20.22 | 70 | 4238 | 37122 | 79702958 |
| Myoglobinuria | 108.23 | 20.22 | 22 | 4286 | 1078 | 79739002 |
| Intentional dose omission | 99.03 | 20.22 | 31 | 4277 | 8786 | 79731294 |
| Product dose omission issue | 77.00 | 20.22 | 80 | 4228 | 247457 | 79492623 |
| Allergy test positive | 68.31 | 20.22 | 14 | 4294 | 714 | 79739366 |
| Systemic inflammatory response syndrome | 53.66 | 20.22 | 21 | 4287 | 11444 | 79728636 |
| Bursitis infective | 49.74 | 20.22 | 12 | 4296 | 1292 | 79738788 |
| Drug reaction with eosinophilia and systemic symptoms | 47.17 | 20.22 | 34 | 4274 | 64210 | 79675870 |
| Face oedema | 46.59 | 20.22 | 25 | 4283 | 28111 | 79711969 |
| Angioedema | 46.37 | 20.22 | 36 | 4272 | 75999 | 79664081 |
| Poor venous access | 41.33 | 20.22 | 20 | 4288 | 18129 | 79721951 |
| Apraxia | 40.37 | 20.22 | 12 | 4296 | 2855 | 79737225 |
| Perseveration | 39.40 | 20.22 | 8 | 4300 | 389 | 79739691 |
| Toxic epidermal necrolysis | 38.33 | 20.22 | 26 | 4282 | 44555 | 79695525 |
| Tachypnoea | 33.17 | 20.22 | 21 | 4287 | 32042 | 79708038 |
| Rhabdomyolysis | 33.16 | 20.22 | 34 | 4274 | 103097 | 79636983 |
| Weight increased | 33.01 | 20.22 | 56 | 4252 | 277330 | 79462750 |
| Pyrexia | 30.60 | 20.22 | 93 | 4215 | 678616 | 79061464 |
| Inflammation | 30.31 | 20.22 | 31 | 4277 | 93722 | 79646358 |
| Hyperreflexia | 27.79 | 20.22 | 12 | 4296 | 8373 | 79731707 |
| Delayed puberty | 25.90 | 20.22 | 5 | 4303 | 187 | 79739893 |
| Hypophosphataemia | 25.62 | 20.22 | 15 | 4293 | 19898 | 79720182 |
| Bone development abnormal | 25.13 | 20.22 | 4 | 4304 | 47 | 79740033 |
| Pseudoporphyria | 25.09 | 20.22 | 6 | 4302 | 622 | 79739458 |
| Paradoxical psoriasis | 24.51 | 20.22 | 5 | 4303 | 249 | 79739831 |
| Device issue | 23.75 | 20.22 | 16 | 4292 | 27092 | 79712988 |
| Hemianopia | 23.32 | 20.22 | 7 | 4301 | 1721 | 79738359 |
| Urticaria | 22.81 | 20.22 | 38 | 4270 | 185163 | 79554917 |
| Increased appetite | 20.82 | 20.22 | 11 | 4297 | 11967 | 79728113 |
| Drug interaction | 20.65 | 20.22 | 59 | 4249 | 415124 | 79324956 |
| Fall | 20.23 | 20.22 | 65 | 4243 | 487564 | 79252516 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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 | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Duchenne muscular dystrophy | indication | 76670001 | DOID:11723 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| ID | Source |
|---|---|
| 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 |
| KR5YZ6AE4B | UNII |
| 189821 | PUBCHEM_CID |
| 18036 | MMSL |
| d04977 | MMSL |
| 006032 | NDDF |
| 116578002 | SNOMEDCT_US |
| 396012006 | SNOMEDCT_US |
| C0244919 | UMLSCUI |
| 13649-57-5 | SECONDARY_CAS_RN |
| 3081431 | PUBCHEM_CID |
| T1LWN33J2P | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EMFLAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52856-501 | TABLET | 6 mg | ORAL | NDA | 27 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 | 52856-502 | 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 | 52856-503 | 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 | 52856-504 | TABLET | 36 mg | ORAL | NDA | 27 sections |
| EMFLAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52856-505 | SUSPENSION | 22.75 mg | ORAL | NDA | 27 sections |
| EMFLAZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52856-505 | SUSPENSION | 22.75 mg | ORAL | NDA | 27 sections |