FDA Approvals / Endocrinology | Regulatory News

FDA Approves Desmoda Oral Solution for Central Diabetes Insipidus

Approval Snapshot

Drug Name Desmoda™ (desmopressin acetate)

Company Eton Pharmaceuticals

Indication Central Diabetes Insipidus

Availability March 9, 2026 (via Anovo)

The Food and Drug Administration (FDA) has officially approved Desmoda™ (desmopressin acetate) oral solution for the management of central diabetes insipidus. The newly approved medication serves as an antidiuretic replacement therapy indicated for both adults and pediatric patients.

Mechanism of Action

Desmoda oral solution contains desmopressin, an analog of the natural pituitary hormone 8-arginine vasopressin (antidiuretic hormone). It works by binding to vasopressin 2 receptors, which increases water reabsorption in the kidney, thereby effectively reducing urine production.

Clinical Pharmacokinetic Data

Pharmacokinetic data from a crossover study demonstrated that the liquid formulation is bioequivalent to an existing FDA-approved oral desmopressin reference product.

The approval was supported by comprehensive data from an open-label, single-dose, 3-treatment, 3-sequence, 3-period, 3-way crossover bioequivalence study that included 75 healthy adults. Study participants were randomly assigned to receive Desmoda or an FDA-approved oral desmopressin reference product. An analysis of the pharmacokinetic data showed that Desmoda was fully bioequivalent to the FDA-approved product.

“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.” Sean Brynjelsen Chief Executive Officer, Eton Pharmaceuticals

Dosing and Administration

• Supply: Desmoda oral solution is supplied in a 145mL bottle. Each mL contains 0.05mg of desmopressin acetate.
• Storage: The oral solution does not require mixing, shaking, or refrigeration.
• Administration: It should be administered using an oral syringe at least 1 hour prior to or 2 hours after food.
• Titration: Dosage should be individualized for each patient and adjusted according to the diurnal pattern of response.

Desmoda is expected to be commercially available to patients on March 9, 2026, exclusively through Anovo, a specialty pharmacy.