ATB200
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- AMICUS THERAPEUTICS, INC. Source: Company record for AMICUS THERAPEUTICS, INC. (opens in a new tab)
- Indication
- Pompe Disease (Late-onset) 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 Current stageFirst trial start 18 Dec 20191 linked trial
- Filed Not yet
- Approved Not yet
The evidence trail loads here.
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 ATB200. Editors add each one with its source.
Filed application
No filed application is on record for ATB200. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for ATB200.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04138277ClinicalTrials.gov record for NCT04138277 (opens in a new tab) | A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD) | Phase 3 | Completed | 119 (actual) | 31 Dec 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04138277 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04138277 Serious adverse events (Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1 to 58 months).): Treatment Continued Group 17 of 81; Treatment Switched Group 10 of 37 Source: ClinicalTrials.gov results for NCT04138277 (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. Publications listing NCT04138277 (3), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
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 ATB200.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT04138277 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
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