Deflazacort
Also known as Emflaza
PTC THERAPEUTICS, INC. PTCT · Duchenne Muscular Dystrophy; Limb-Girdle Muscular Dystrophy
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- PTC THERAPEUTICS, INC. PTCT Source: Company record for PTC THERAPEUTICS, INC. (opens in a new tab)
- Indications
- Duchenne Muscular Dystrophy; Limb-Girdle Muscular Dystrophy Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 31 Oct 20182 linked trials
- Filed Completed
- Approved Current stage
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Deflazacort. Editors add each one with its source.
Filed application
No filed application is on record for Deflazacort. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Deflazacort.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03783923ClinicalTrials.gov record for NCT03783923 (opens in a new tab) | A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I) | Phase 3 | Terminated | 11 (actual) | 1 Jan 2021 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03783923 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03783923 Serious adverse events (Baseline up to Week 52): Deflazacort 0 of 7 Source: ClinicalTrials.gov results for NCT03783923 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03642145ClinicalTrials.gov record for NCT03642145 (opens in a new tab)PTCEMF | A Study of Deflazacort (Emflaza®) in Participants With Duchenne Muscular Dystrophy (DMD) | Phase 3 | Withdrawn | 0 (actual) | 31 Jul 2021 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Deflazacort.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 208684 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- Drugs@FDA 208685 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03783923 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03642145 (opens in a new tab) Licence: public-domain. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.