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 does not produce enough vasopressin, a hormone that normally tells the kidneys to conserve water. Desmoda is an oral liquid containing desmopressin, a lab-made copy of that missing hormone. By replacing it, the drug helps the kidneys reduce excessive urination, potentially restoring the body's fluid balance.
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
