Swedish pharmaceutical company Egetis Therapeutics AB (STO:EGTX) announced on Monday that the United States Patent and Trademark Office has issued a Notice of Allowance for its patent application covering pharmaceutical compositions for treating monocarboxylate transporter 8 (MCT8) deficiency.
The patent protects a composition containing tiratricol designed to correct disrupted thyroid hormone signalling and includes methods of treatment, dosing regimens, and specific excipients. Once administrative processes are completed, the patent is expected to be issued and listed in the Orange Book, with an anticipated expiration in 2045.
This milestone strengthens Egetis' intellectual property portfolio supporting its lead investigational therapy. The company plans to seek corresponding patent protection in Europe, Japan, and other territories based on a PCT International Patent Application.
Egetis submitted a new drug application to the US Food and Drug Administration (FDA) for its lead drug candidate Emcitate (tiratricol) on 29 January 2026. The FDA is expected to confirm filing completeness within 60 days, and, if Priority Review is granted, a regulatory decision is anticipated by September 2026.
Emcitate was developed for the treatment of patients with MCT8 deficiency, a highly debilitating rare disease with no available treatment. In February 2025 the European Commission approved Emcitate as the first and only treatment for MCT8 deficiency in EU.
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