Data updated: Nov 8, 2026
EMCITATE (tiratricol) · RARE THYROID
Approved 2026-09-28
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-09-28
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
Latest EMCITATE News
All EMCITATE news →EMCITATE Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What EMCITATE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05579327 ReTRIACt | MCT8-2021-3 | Ph 3 | completed | Withdrawal of Tiratricol Treatment in Males With Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency) |
| NCT02396459 | MCT8-2019-2 | Ph 2 | active not recruiting | Triac Trial II in MCT8 Deficiency Patients |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EMCITATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.