Overview
Deflazacort, also known as Emflaza, is a corticosteroid prodrug used as an agent to manage Duchenne Muscular Dystrophy (DMD). It is marketed by Marathon Pharmaceuticals and was approved in February 2017 by the FDA. Duchenne Muscular Dystrophy is an inherited disorder resulting from mutations of the dystrophin gene, which is important for muscle function. This disease can cause serious muscle weakness and progressive breathing and cardiovascular disability, severely impacting patient quality of life and survival. This disease usually manifests by muscle weakness in early childhood followed by loss of the ability to walk (ambulation) as early as age 7. Deflazacort delays the onset of muscle related complications resulting from DMD, prolonging the lives of children diagnosed with this disease and exerting less harmful effects on the bone health and weight than other steroid medications.
Indication
⑴用于原发性肾上腺皮质功能减退、风湿病、胶原性疾病、皮肤病、变态反应性疾病、眼科疾病、暴发性和播散性肺结核、造血系统疾患、溃疡性结肠炎、特发性肾病综合征等。 ⑵用于治疗杜氏肌营养不良（DMD）。
Associated Conditions
- Duchenne Muscular Dystrophy (DMD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/03/10 | Phase 1 | UNKNOWN | Parc de Salut Mar | ||
2020/09/10 | Phase 1 | Completed | Catabasis Pharmaceuticals | ||
2020/04/28 | Phase 4 | Active, not recruiting | Yuzuncu Yıl University | ||
2020/01/13 | Phase 2 | Active, not recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2018/12/21 | Phase 3 | Terminated | |||
2018/08/22 | Phase 3 | Withdrawn | |||
2015/10/30 | N/A | APPROVED_FOR_MARKETING | |||
2015/06/30 | Phase 1 | Completed | |||
2014/11/20 | Phase 1 | Completed | |||
2014/11/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Upsher-Smith Laboratories, LLC | 0832-0816 | ORAL | 30 mg in 1 1 | 5/1/2025 | |
| PTC Therapeutics, Inc. | 52856-505 | ORAL | 22.75 mg in 1 mL | 10/6/2021 | |
| Upsher-Smith Laboratories, LLC | 0832-0817 | ORAL | 36 mg in 1 1 | 5/1/2025 | |
| Aurobindo Pharma Limited | 59651-600 | ORAL | 18 mg in 1 1 | 2/12/2024 | |
| PTC Therapeutics, Inc. | 52856-501 | ORAL | 6 mg in 1 1 | 10/6/2021 | |
| PTC Therapeutics, Inc. | 52856-504 | ORAL | 36 mg in 1 1 | 10/6/2021 | |
| Aurobindo Pharma Limited | 59651-602 | ORAL | 36 mg in 1 1 | 2/12/2024 | |
| Aurobindo Pharma Limited | 59651-599 | ORAL | 6 mg in 1 1 | 2/12/2024 | |
| Upsher-Smith Laboratories, LLC | 0832-0815 | ORAL | 18 mg in 1 1 | 5/1/2025 | |
| PTC Therapeutics, Inc. | 52856-503 | ORAL | 30 mg in 1 1 | 10/6/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DEFLAZACORT CINFA 6 mg COMPRIMIDOS EFG | Laboratorios Cinfa S.A. | 73872 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| DEFLAZACORT PENSA 30 MG COMPRIMIDOS EFG | Towa Pharmaceutical S.A. | 73882 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| DEFLAZACORT VIR 6 mg COMPRIMIDOS EFG | Industria Quimica Y Farmaceutica Vir S.A. | 64709 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| DEFLAZACORT STADA 6 mg COMPRIMIDOS EFG | Laboratorio Stada S.L. | 66989 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| ZAMENE 6 mg COMPRIMIDOS | Laboratorios Menarini S.A. | 58654 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| DEFLAZACORT VIR 30 mg COMPRIMIDOS EFG | Industria Quimica Y Farmaceutica Vir S.A. | 64708 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| DEFLAZACORT SUN 30 mg COMPRIMIDOS EFG | 71890 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized | |
| DEZACOR 22,75 mg/ml GOTAS ORALES EN SUSPENSION | 61049 | GOTAS ORALES EN SUSPENSIÓN | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| DEFLAZACORT PENSA 6 MG COMPRIMIDOS EFG | Towa Pharmaceutical S.A. | 73883 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| DEFLAZACORT SANDOZ 30 mg COMPRIMIDOS EFG | Sandoz Farmaceutica S.A. | 64926 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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