FDA

FDA greenlights Desmoda oral solution for central diabetes insipidus

March 2, 2026

Brand name: Desmoda

Generic name: desmopressin acetate

Manufacturer: Eton Pharmaceuticals

Approval date: February 25, 2026

FDA approved Desmoda (desmopressin acetate) oral solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), in adults and pediatric patients.

According to a manufacturer press release, Desmoda is supplied as a ready-to-use oral solution (0.05 mg/mL) that doesn’t require tablet splitting, crushing, refrigeration, mixing, or shaking.

In a bioequivalence trial involving 75 participants, the patented oral solution of desmopressin showed pharmacokinetic equivalence to the FDA‑approved reference product containing the same active ingredient. Healthy adult volunteers were randomly assigned to receive both the test and reference formulations in an open‑label, balanced, randomized, single‑dose study designed as a three‑treatment, three‑sequence, three‑period crossover.

Source:

Eton Pharmaceuticals announces US FDA approval for Desmoda™ (desmopressin acetate) oral solution. [News release]. 2026. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-desmodatm

Eton Pharmaceuticals Announces Positive Pivotal Clinical Study Results for Product Candidate ET-600. [News release]. 2025. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-positive-pivotal-clinical-study