FDA Approves Desmopressin Acetate Oral Solution in Central Diabetes Insipidus

The FDA has approved a hydrocortisone oral solution desmopression acetate (Desmoda; Eton Pharmaceuticals) for the treatment of central diabetes insipidus (CDI), also referred to as arginine vasopressin deficiency (AVP-D), in patients of all ages.¹ This approval marks the first and only FDA-approved oral liquid formulation of desmopressin, designed to provide precise, individualized dosing in a condition where maintaining water balance is critical.

“Desmoda represents one of the most important product launches in Eton’s history,” said Sean Brynjelsen, chief executive officer, Eton Pharmaceuticals, in a statement. “It builds on our strategy of delivering differentiated therapies to rare endocrine patients. By leveraging our existing pediatric endocrinology platform, we believe Desmoda has the potential to become a foundational therapy in this category. In central diabetes insipidus, effective long-term management depends on accurately matching desmopressin dosing to each patient’s diurnal pattern of water balance. Historically, clinicians have primarily relied on formulations that were not designed for fine dose adjustments or had other administration issues, and both clinicians and families often had to rely on workarounds. Desmoda introduces a liquid solution designed to deliver individualized dosing precision and consistency for patients across the age spectrum.”

CDI is a rare but serious endocrine disorder caused by insufficient vasopressin production from the hypothalamus or posterior pituitary, leading to excessive urination and thirst. Current desmopressin therapy is standard of care, but dosing must be carefully individualized to avoid complications from over- or under-treatment. Desmoda, supplied as a ready-to-use oral solution (0.05 mg/mL), eliminates the need for tablet splitting, crushing, refrigeration, mixing, or shaking, supporting accurate titration across the age spectrum.

Desmoda will be available March 9, 2026, through Anovo, a specialty pharmacy focused on rare and chronic conditions. Patients can access the Eton Cares Program, which provides prescription fulfillment, insurance support, educational resources, and financial assistance, including co-pay support for qualified patients to achieve $0 co-pay.

Eton estimates more than 13,000 US patients with CDI, including 3000 to 4000 pediatric patients, may benefit from Desmoda. This launch complements Eton’s existing pediatric endocrinology portfolio.

“Central diabetes insipidus requires careful, individualized management, where dosing precision and flexibility truly matter,” said Lewis Blevins, MD, director of the California Center for Pituitary Disorders and professor of medicine and neurological surgery at the University of California, San Francisco, in a statement. “Having a liquid formulation of desmopressin has the potential to meaningfully support how we initiate and manage therapy. It’s encouraging to see innovation that directly addresses real-world challenges faced by clinicians and families and gives greater confidence when tailoring treatment across age groups.”

This launch complements Eton’s existing pediatric endocrinology portfolio, which includes hydrocortisone (Alkindi Sprinkle), hydrocortisone (Khindivitm), and mecasermin (Increlex).^1,2

References

1. Eton Pharmaceuticals announces US FDA approval for Desmoda. (desmopressin acetate) Oral Solution. Eton Pharmaceuticals. News release. February 25, 2026. Accessed February 25, 2026. https://finance.yahoo.com/news/eton-pharmaceuticals-announces-u-fda-184700806.html
2. Iapoce C. FDA approves hydrocortisone oral solution for adrenal insufficiency. HCPLive®. May 29, 2025. Accessed February 25, 2026. https://www.hcplive.com/view/fda-approves-hydrocortisone-oral-solution-for-adrenal-insufficiency?utm_source=chatgpt.com