Emcitate (tiratricol)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- tiratricol
- Company
- Rare Thyroid Therapeutics International AB
- Status
- Authorised
- Therapeutic area
- Thyrotoxicosis; Heredodegenerative Disorders, Nervous System
- EU approval
- Wed 12 Feb 2025
- Designations
- Orphan
- Application
- EMEA/H/C/005220
- ATC
- H03AA04
- Official record
- www.ema.europa.eu
Indication
Emcitate is indicated for the treatment of peripheral thyrotoxicosis in patients with monocarboxylate transporter 8 (MCT8) deficiency (Allan-Herndon-Dudley Syndrome), from birth.
Regulatory milestones
Mon 28 Sep 2026🇺🇸 FDA approval
FDA approves Emcitate (tiratricol), a new medicine
Rare Thyroid; NDA220963; New molecular entity, Priority review; tablet, for suspension · source
Same substance in other markets
- 🇺🇸 Emcitate Approved · Rare Thyroid
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.