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, also called arginine vasopressin deficiency, occurs when the brain does not make enough vasopressin, the hormone that helps the body hold onto water, so the body produces large amounts of urine and loses fluid. Desmoda is a ready-to-use oral liquid form of desmopressin,
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
