Eton Pharmaceuticals announced positive results from a bioequivalence study of ET-600, its patented oral solution of desmopressin for central diabetes insipidus. The study demonstrated ET-600’s pharmacokinetic equivalence to the FDA-approved reference product, paving the way for an NDA submission in April 2025. If approved, ET-600 will be the only FDA-approved oral liquid desmopressin formulation.
This development is particularly important for pediatric patients with central diabetes insipidus, who require precise and titratable dosing. Currently, achieving this level of precision with existing formulations can be challenging. The availability of a liquid formulation offers clinicians a more effective means of managing the condition in this sensitive population, potentially improving treatment outcomes and quality of life. This advancement also underscores the company’s commitment to addressing unmet needs in rare pediatric diseases.
The successful bioequivalence study involved 75 healthy adults in a randomized, single-dose, three-way crossover design. Eton holds a patent for ET-600’s formulation extending to 2044, with an additional patent application under review. The company estimates the addressable US pediatric patient population for central diabetes insipidus to be approximately 3,000. Eton has already initiated pre-launch commercial activities, anticipating a potential product launch in the first quarter of 2026.
The positive results of this pivotal study represent a significant step forward for Eton Pharmaceuticals. A potential approval for ET-600 would not only diversify its portfolio of rare disease treatments but also establish the company as a key player in the central diabetes insipidus market. This could translate into increased market share and revenue growth, further strengthening Eton’s position in the rare disease pharmaceutical sector. Looking ahead, the timely NDA submission and subsequent FDA review process will be critical milestones to watch.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
