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 |
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 | 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 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 | 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 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 |
|---|---|---|---|---|---|---|
| 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:
| 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, 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:
| 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 |
| 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:
| 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 | 52856-502 | 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 |