FDA Approves Desmopressin Acetate Oral Solution for Central Diabetes Insipidus

The US Food and Drug Administration (FDA) has approved desmopressin acetate oral solution (DESMODA) for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy in adults and pediatric patients. According to Eton Pharmaceuticals, the product is the first FDA-approved oral liquid formulation of desmopressin for this indication and is expected to be commercially available on March 9.

Central diabetes insipidus is a rare disorder caused by insufficient production of vasopressin from the hypothalamus or posterior pituitary, resulting in polyuria and polydipsia. Desmopressin remains the standard of care; however, dosing must be individualized to avoid complications related to over- or under-replacement, particularly hyponatremia and water intoxication.

The newly approved formulation is supplied as a ready-to-use oral solution at a concentration of 0.05 mg/mL and does not require tablet splitting, crushing, refrigeration, mixing, or shaking. The company stated that the liquid formulation is intended to facilitate precise, individualized titration across age groups, including pediatric patients.

Eton estimates that more than 13 000 individuals in the US have central diabetes insipidus, including approximately 3000 to 4000 pediatric patients. The company projects potential peak annual sales of $30 to $50 million and notes patent protection through 2044.

“DESMODA represents one of the most important product launches in Eton’s history. It builds on our strategy of delivering differentiated therapies to rare endocrine patients. By leveraging our existing pediatric endocrinology platform, we believe DESMODA has the potential to become a foundational therapy in this category,” Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals, said in a press release. “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.”

Desmopressin is contraindicated in patients with hypersensitivity to desmopressin acetate or any component of the formulation, in adults with moderate to severe renal impairment (creatinine clearance <50 mL/min), and in patients with hyponatremia or a history of hyponatremia.

The prescribing information includes a boxed warning regarding hyponatremia. Excessive fluid intake in the presence of desmopressin’s antidiuretic effect can lead to water intoxication and hyponatremia, which may manifest as headache, nausea, vomiting, weight gain, lethargy, confusion, muscle cramps, seizures, coma, respiratory arrest, or death. Fluid restriction during treatment is recommended, particularly in pediatric and geriatric patients. Serum sodium should be monitored more frequently in patients with conditions associated with fluid and electrolyte imbalance or in those receiving concomitant medications that may increase the risk of hyponatremia.

Desmopressin acetate may also cause fluid retention and should be used with caution in patients with heart failure or uncontrolled hypertension. The product is not recommended in patients at risk for increased intracranial pressure or those with a history of urinary retention.

Desmopressin contains benzoic acid, a metabolite of benzyl alcohol. Serious adverse reactions, including fatal reactions, have been reported in low-birth-weight and preterm neonates exposed to benzyl alcohol-containing drugs intravenously. Although the relationship between systemic benzoic acid exposure and toxicity is not well characterized, caution is advised in low-birth-weight or preterm neonates, with monitoring for signs of metabolic acidosis.

Serious adverse reactions associated with desmopressin include hyponatremia, fluid retention, hypersensitivity reactions, and potential benzyl alcohol toxicity in neonates. Common adverse reactions reported with desmopressin acetate include abnormal thinking, diarrhea, and edema or weight gain. Additional adverse reactions reported in clinical studies or postmarketing experience include nausea, vomiting, headache, fatigue, dizziness, water intoxication, seizures, confusion, hallucinations, urinary retention, and rash.

Desmopressin will be distributed exclusively through a specialty pharmacy and supported by a patient assistance program that includes insurance benefits investigation and co-pay support for eligible patients. Clinicians may prescribe the medication electronically or via fax referral.

The approval expands available formulations of desmopressin for central diabetes insipidus and introduces an oral liquid option intended to facilitate individualized dose titration across the lifespan.

Reference: Eton Pharmaceuticals Announces U.S. FDA Approval for DESMODA™ (desmopressin acetate) Oral Solution. News release. Eton Pharmaceuticals. February 25, 2026. Accessed February 26, 2026. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-desmodatm