for central diabetes insipidus (arginine vasopressin deficiency) — patients of all ages
NDA· Standard Review
FDA approved Desmoda (desmopressin acetate) Oral Solution on February 25, 2026 — on the assigned PDUFA target date. First and only FDA-approved oral liquid formulation of desmopressin; supports precise individualized dosing without tablet splitting, crushing, refrigeration, mixing, or shaking. Commercial launch expected March 9, 2026. Eton estimates ~13,000 US patients (~3,000-4,000 pediatric) with peak sales potential $30-50M annually.
About
Central diabetes insipidus is a condition where the brain fails to produce enough vasopressin, a hormone that helps the kidneys retain water, leading to excessive urination and dehydration. Desmoda is an oral liquid form of desmopressin that mimics the action of vasopressin, helping the kidneys reduce urine output and maintain proper hydration. This ready-to-use solution may offer easier and more precise dosing, particularly for children and those who struggle with traditional tablet forms.
Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-Inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose
