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
Deflazacort, Emflaza
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
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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 1,907 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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