New Drugs and Therapeutics Update: DESMODA™ (desmopressin acetate) Oral Solution
Prepared by Daniel Mak, MD
DESMODA® (desmopressin acetate) Oral Solution
On February 25th, 2026, the FDA approved DESMODA™ (desmopressin acetate) oral solution for the management of central diabetes insipidus (arginine vasopressin deficiency) as antidiuretic replacement therapy in both adult and pediatric patients of all ages.1 DESMODA™ is the only FDA-approved desmopressin oral solution. This provides an alternative option for children who require low doses that are too small for easy splitting of tablets, require crushing of tablets, or have difficulty with subcutaneous injections. DESMODA® works by binding to vasopressin 2 (V2) receptors in the kidneys, regulating water reabsorption and urine concentration to help maintain the body’s fluid balance.1 It is not indicated for the treatment of nephrogenic diabetes insipidus.
DESMODA™ is supplied as an oral solution containing 0.05 mg of desmopressin acetate per 1 mL. Once opened, the bottle remains stable for up to 120 days and may be stored in the refrigerator or at room temperature (up to 77°F).2 As it is a solution, it does not need to be mixed (i.e. shaken). DESMODA™ is dispensed with a 0.5 mL syringe. The smallest dose that can be accurately delivered is 0.1 mL, or 5 mcg.3
Bioequivalence
In a bioequivalence study conducted in 75 healthy adult subjects, the study drug (desmopressin acetate oral solution) demonstrated pharmacokinetic equivalence to the U.S. Food and Drug Administration (FDA)-approved reference product of the same active ingredient.4
There is no information regarding bioequivalence or instructions on switching from subcutaneous injection desmopressin acetate to oral solution.
Special Considerations
DESMODA™ should be used with caution in low-birth-weight neonates (less than 2,500 grams) and preterm neonates (gestational age less than 34 weeks). DESMODA™ contains benzoic acid, and there is a risk of life-threatening benzyl alcohol toxicity (such as gasping syndrome) and metabolic acidosis in these very young infants.2
Availability
DESMODA™ is produced by Eton Pharmaceuticals and was to be available March 9, 2026, through Anovo Specialty Pharmacy. Patients can access the Eton Cares Program, which provides prescription fulfillment, insurance support, educational resources, and financial assistance, including co-pay support for qualified patients to achieve $0 co-pay.1
References:
- Eton Pharmaceuticals announces US FDA approval forDesmoda™ (desmopressin acetate) oral solution. [News release]. 2026.
- Desmodaprescribing information. https://desmoda.com/PI.pdf
- Eton Pharmaceuticals, Senior Director, Medical Affairs (via email).
- Eton Pharmaceuticals Announces Positive Pivotal Clinical Study Results for Product Candidate ET-600. [News release]. 2025.