CDEK
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deflazacort

Trade name: emflaza

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 9, 2017

Deflazacort is a glucocorticoid developed for the treatment of different inflammatory and immune conditions. The drug is rapidly metabolized to an active metabolite, 21-hydroxy-deflazaxort that may cross the blood brain barrier. Deflazacort acts by suppressing inflammatory response. — NCATS

Clinical trial activity

16 trials · 19 clinical orgs · 10 marketing orgs

Phase 1
8
Phase 2
3
Phase 3
5
Phase 4
2

Earliest trial started Sep 1, 2003 (NCT00527228)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Aug 16, 2013

    Orphan Drug Designation

  3. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  4. Feb 9, 2017

    Gilead Sciences — Earliest FDA Approval

  5. Feb 9, 2017

    PTC Therapeutics — NDA Secondary Org

  6. Feb 9, 2017

    Gilead Sciences — NDA Organization

2020s

  1. Mar 29, 2023

    Aurobindo Pharma — Marketing Organization

  2. Apr 25, 2024

    Tris Pharma, Inc. — Marketing Organization

  3. Nov 5, 2024

    Upsher-Smith Laboratories — Marketing Organization

  4. Mar 18, 2025

    Sun Pharmaceuticals — Marketing Organization

  5. Apr 8, 2025

    Zydus Discovery DMCC — Marketing Organization

  6. Jun 30, 2025

    Aucta Pharms — Marketing Organization

  7. Dec 12, 2025

    Amneal Pharmaceuticals — Marketing Organization

  8. May 28, 2026

    CARNEGIE — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackFeb 9, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CC1=N[C@@]2([C@@H](C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@]5(C)[C@H]4[C@@H](O)C[C@]23C)O1)C(=O)CO
Mol. weight
399.4801 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in classProdrug

Sources

Also known as

  • (11 beta,16 beta)-21-(acetyloxy)-11-hydroxy-2'- methyl-5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20- dione
  • azacort
  • azacortinol
  • calcort
  • calcort
  • calcort
  • calcort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • deflazacort
  • dezacor
  • dezacor
  • dezacort
  • emflaza
  • emflaza
  • emflaza
  • flantadin
  • lantadin
  • mdl-458
  • mdl-458
  • oxazacort
  • zamene
  • zamene
  • zamene

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04791345Phase 1Feb 26, 2021Institut Hospital del Mar d'Investigacions Mèdiques
NCT04543370Phase 1Aug 8, 2020Catabasis
NCT04227483Phase 2/Phase 3 (Phase 3)Jan 15, 2020Postgraduate Institute of Medical Education and Research
NCT03783923Phase 3May 15, 2019PTC Therapeutics
NCT04365088Phase 4Dec 15, 2018Yuzuncu Yıl University
NCT03642145Phase 3Oct 31, 2018PTC Therapeutics
NCT02592941N/AOct 29, 2015Dohmen Life Science Services, Marathon Pharmaceuticals, Parexel
NCT02485431Phase 1Jun 1, 2015ICON, Marathon Pharmaceuticals
NCT02251600Phase 1Dec 1, 2014Celerion, Marathon Pharmaceuticals
NCT02295748Phase 1Dec 1, 2014Marathon Pharmaceuticals
NCT02286622Phase 1Dec 1, 2014Marathon Pharmaceuticals
NCT02286609Phase 1Dec 1, 2014Marathon Pharmaceuticals
NCT02286635Phase 1Nov 1, 2014Marathon Pharmaceuticals
NCT01603407Phase 3Jan 1, 2013National Institute of Neurological Disorders and Stroke (NINDS), Newcastle University, University of Freiburg, University of Rochester
NCT01817322Phase 4Jun 1, 2011Ajou University, Seoul National University, Sungkyunkwan University, Yonsei University
NCT00527228Phase 2/Phase 3 (Phase 3)Sep 1, 2003Ludwig Maximilians University
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (19)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Marathon PharmaceuticalsFor profit7722014
PTC TherapeuticsFor profit2212018
Ajou UniversityAcademic/Hospital1012011
CatabasisFor profit1112020
CelerionFor profit1012014
Dohmen Life Science ServicesFor profit1012015
ICONFor profit1012015
Institut Hospital del Mar d'Investigacions MèdiquesAcademic/Hospital1112021
Ludwig Maximilians UniversityAcademic/Hospital1112003
National Institute of Neurological Disorders and Stroke (NINDS)Government1012013
Newcastle UniversityAcademic/Hospital1012013
ParexelFor profit1012015
Postgraduate Institute of Medical Education and ResearchAcademic/Hospital1112020
Seoul National UniversityAcademic/Hospital1012011
Sungkyunkwan UniversityAcademic/Hospital1112011
University of FreiburgAcademic/Hospital1012013
University of RochesterAcademic/Hospital1112013
Yonsei UniversityAcademic/Hospital1012011
Yuzuncu Yıl UniversityAcademic/Hospital1112018
19 organizations
Page 1 / 1

Marketing (12)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGDec 12, 2025
Aucta PharmsFor profitMKTGJun 30, 2025
Aurobindo PharmaFor profitMKTGMar 29, 2023
Aurobindo PharmaFor profitSYNFeb 9, 2024
CARNEGIEFor profitMKTGMay 28, 2026
Gilead SciencesFor profitNDAFeb 9, 2017
PTC TherapeuticsFor profitNDA2Feb 9, 2017
Sun PharmaceuticalsFor profitMKTGMar 18, 2025
Sun PharmaceuticalsFor profitSYNJan 27, 2026
Tris Pharma, Inc.For profitMKTGApr 25, 2024
Upsher-Smith LaboratoriesFor profitMKTGNov 5, 2024
Zydus Discovery DMCCFor profitMKTGApr 8, 2025