Drugs / Deflazacort
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | EMFLAZA | — | 2019-06-07 | fda.gov ↗ |
| Approved | US (FDA) | EMFLAZA | — | 2017-02-09 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT04791345 | Feb 2021 → Feb 2022 | — | Parc de Salut Mar | Unknown | No outcome recorded |
| Phase 1 | NCT04543370 | Aug → Sep 2020 | — | Catabasis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02485431 | Jun → Aug 2015 | — | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02251600 | Dec 2014 → Oct 2015 | Duchenne muscular dystrophy | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02286609 | Dec 2014 → Feb 2015 | — | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02286622 | Dec 2014 → Feb 2015 | impaired renal function disease | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02295748 | Dec 2014 → Aug 2017 | Duchenne muscular dystrophy | PTC Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02286635 | Nov → Dec 2014 | — | PTC Therapeutics | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04227483 | Jan 2020 → Jul 2025 overdue | allergic bronchopulmonary aspergillosis | Post Graduate Institute of Medical Education and Research, Chandigarh | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03783923 | Oct 2019 → Jan 2021 | limb-girdle muscular dystrophy | PTC Therapeutics | Terminated | No outcome recorded |
| Phase 3 | NCT03642145 | Oct 2018 → Jul 2021 | Duchenne muscular dystrophy | PTC Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT01603407 | Jan 2013 → Nov 2019 | Duchenne muscular dystrophy | University of Rochester | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04365088 | Dec 2018 → Nov 2023 | impacted teeth, multiple | Yuzuncu Yil University | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02592941 | — | Duchenne muscular dystrophy | PTC Therapeutics | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00527228 Comparator | Sep 2003 → Apr 2008 | Miyoshi myopathy, autosomal recessive limb-girdle muscular dystrophy type 2B | Ludwig-Maximilians - University of Munich | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04632940 Background | Mar 2021 → Jun 2023 | Duchenne muscular dystrophy | Kyntra Bio | Terminated | No outcome recorded |
| Phase 3 | NCT04371666 Background | Aug 2020 → Feb 2023 | Duchenne muscular dystrophy | Kyntra Bio | Terminated | No outcome recorded |
| Phase 3 | NCT01282073 Comparator | Mar 2011 → May 2016 | membranous glomerulonephritis | Kyungpook National University Hospital | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01817322 Background | Jun 2011 → Aug 2013 | chronic kidney disease | Samsung Medical Center | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | deflazacort | “Pamrevlumab 35 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally for up to 52 weeks” NCT04371666 ↗18“Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet.” NCT01282073 ↗ “Systemic deflazacort or equivalent potency of corticosteroids administered orally” NCT04632940 ↗ |
| Known as | Azacortinol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | Calcort | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | DL-458IT | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | Emflaza | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | L-5458 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | MDL 458 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Known as | Zamene | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201891 ↗ |
| Action | Activate | “Glucocorticoid receptor agonist” CHEMBL1201891 ↗ |
| Modality | Other / unclassified | “Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases.” NCT02286635 ↗ |
| Route | Oral | “by the mouth” NCT01603407 ↗ |
| Target | NR3C1 | “Glucocorticoid receptor agonist” CHEMBL1201891 ↗ |