Pipeline
Emcitate® (tiratricol)
Emcitate has been developed as a treatment of patients with MCT8 deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) Emcitate has shown highly significant and clinically relevant results on serum thyroid hormone T3 levels and secondary clinical endpoints. Emcitate was approved in the EU in February 2025 and launched in Germany in May 2025. In the U.S. Egetis completed a rolling NDA on September 29, 2026. The FDA is expected to confirm within 60 days that the NDA submission is complete. As a designated Fast Track and Breakthrough Therapy, Egetis has requested Priority Review, and if granted, the FDA review should be completed within six months following the 60-day filing review period. Thus, Egetis anticipates regulatory decision on the NDA application in September 2026.
Emcitate holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH- β) in the US and the EU. Emcitate has been granted Rare Pediatric Disease Designation (RPD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval.
Aladote®
Aladote® a first-in-class drug candidate, is being developed to reduce the risk of acute liver injury associated with acetaminophen/paracetamol poisoning. A proof of principle study has been completed. Design of pivotal Phase IIb/III study for Aladote® finalized after completed interactions with FDA, EMA and MHRA. Aladote® has been granted Orphan Drug Designation in the US and EU.
