Deflazacort
Deflazacort, Emflaza (deflazacort) is a small molecule pharmaceutical. Deflazacort was first approved as Emflaza on 2017-02-09. It is used to treat duchenne muscular dystrophy and inflammation in the USA.
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Commercial
Trade Name
FDA
EMA
Emflaza (generic drugs available since 2024-02-09)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Deflazacort
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EMFLAZA | PTC Therapeutics | N-208684 RX | 2017-02-09 | 4 products, RLD, RS |
| EMFLAZA | PTC Therapeutics | N-208685 RX | 2017-02-09 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| deflazacort | ANDA | 2024-06-13 |
| deflazacort oral suspension | ANDA | 2024-06-28 |
| emflaza | New Drug Application | 2023-02-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| inflammation | MP_0001845 | D007249 | — |
| duchenne muscular dystrophy | EFO_0000429 | D020388 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DEFLAZACORT, EMFLAZA, PTC THERAP | |||
| 2026-06-07 | ODE-252 | ||
| 2024-02-09 | ODE-130 | ||
Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
23 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | — | — | — | 1 | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 1 | — | 1 |
| Trismus | D014313 | — | — | — | — | — | 1 | — | 1 |
| Impacted tooth | D014095 | HP_0011079 | K01.1 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Muscular dystrophies | D009136 | HP_0003560 | G71.0 | 2 | — | 5 | — | 3 | 10 |
| Duchenne muscular dystrophy | D020388 | EFO_0000429 | — | 2 | — | 4 | — | 3 | 9 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | 1 | 2 |
| Limb-girdle muscular dystrophies | D049288 | EFO_0000758 | G71.03 | — | 1 | 2 | — | — | 2 |
| Glomerulonephritis | D005921 | HP_0000099 | N05 | — | — | 1 | — | — | 1 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | — | 1 | — | — | 1 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 1 | 1 | — | — | 1 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 1 | 1 | — | — | 1 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | — | — | 1 | 1 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Deflazacort |
| INN | deflazacort |
| Description | Deflazacort is a corticosteroid hormone. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)OCC(=O)[C@@]12N=C(C)O[C@@H]1C[C@H]1[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]12C |
Identifiers
| PDB | — |
| CAS-ID | 14484-47-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201891 |
| ChEBI ID | — |
| PubChem CID | 189821 |
| DrugBank | DB11921 |
| UNII ID | KR5YZ6AE4B (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Emflaza – PTC Therapeutics
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,888 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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3,867 adverse events reported
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