LIONNS-D2 Project – Production of T3S API, IMP and FDF

Cardiff University’s School of Medicine is procuring the manufacture of a novel investigational medicinal product (IMP), Triiodothyronine sulphate (T3S), for use in a Phase 2b clinical trial. The service includes the production of the active pharmaceutical ingredient (API), the IMP, and the finished drug formulation (FDF) in blister packs. This bespoke drug is intended for hypothyroid patients with a specific genetic variation affecting thyroid hormone metabolism. The supplier will manufacture the product to GMP standards, using a validated Route of Synthesis supported by existing preclinical and toxicology data.