FDA approves oral liquid desmopressin for central diabetes insipidus

The FDA has approved oral desmopressin acetate (Desmoda; Eton Pharmaceuticals) for treating central diabetes insipidus, also known as arginine vasopressin deficiency, in both adult and pediatric patients, according to Eton Pharmaceuticals.¹

This marks the first FDA approval of an oral liquid desmopressin formulation designed for individualized dosing. This is vital when managing a disease that requires careful titration to maintain water balance. The formulation does not require refrigeration, crushing, shaking, or mixing, with a 0.05-mg/mL dose immediately ready for use.¹

“Central diabetes insipidus requires careful, individualized management, where dosing precision and flexibility truly matter,” said Lewis Blevins, MD, professor at the University of California, San Francisco. “Having a liquid formulation of desmopressin has the potential to meaningfully support how we initiate and manage therapy.”¹

Addressing the need for individualized dosing

According to Eton, there are more than 13,000 patients with central diabetes insipidus in the United States, 3000 to 4000 of whom are pediatric patients. These patients require desmopressin matched to their individual diurnal pattern of water balance for effective long-term management.¹

Sean Brynjelsen, CEO of Eton Pharmaceuticals, noted that clinicians previously had to rely on formulations not designed for fine dose adjustments. This often forced clinicians and families to rely on workarounds. Desmopressin acetate allows patients of all ages to receive precise dosing.¹

Central diabetes insipidus, caused by inadequate production of the hormone vasopressin from the hypothalamus or posterior pituitary, is a severe condition that can lead to complications if dosing is not individualized. With oral dosing, therapy can be fine-tuned and adjusted over time if needed.¹

“It’s encouraging to see innovation that directly addresses real-world challenges faced by clinicians and families and gives greater confidence when tailoring treatment across age groups,” said Blevins.¹

Advantages and safety concerns of desmopressin

Eton Pharmaceuticals highlighted the limitations of other treatment methods.² These included inconsistent doses when splitting tablets, discomfort and injection site reactions from injections, and inconsistency caused by nasal congestion or inflammation from nasal sprays.

In comparison, oral desmopressin gives patients precision, flexibility, consistency, and control in their treatment. The formulation was expected to be available for health care professionals to access in early March.²

Safety indications have been noted for oral desmopressin. These include contraindications in patients with hypersensitivity to any of the drug’s components, moderate to severe renal impairment, or current or prior hyponatremia.²

In patients with hyponatremia, the antidiuretic effect of desmopressin may cause water intoxication from excessive fluid intake. This highlights a need for fluid restriction, especially in pediatric or geriatric patients with an increased risk.²

Additional contraindications

Patients with conditions linked to fluid and electrolyte imbalance should undergo frequent monitoring of serum sodium. Additionally, patients with heart failure or uncontrolled hypertension should remain cautious of fluid retention.²

Hypersensitivity reactions have also been reported from desmopressin acetate administered intravenously and nasally. However, these reactions are rare.²

Benzoic acid, a metabolite of benzyl alcohol, is included in desmopressin acetate. While there is little data about the link between systemic benzoic acid exposure and toxicity, severe adverse reactions may occur in low–birth weight and preterm neonates. Investigators recommended monitoring for signs of metabolic acidosis in these populations.²

“A liquid option like Desmoda is a meaningful improvement because it helps make sure that the dose is always right, every time. This is very important in cases where the wrong dose can have a big impact," said Muriël Marks, board member of Worldwide Adrenal and Pituitary Organizations.¹

References

1. Eton Pharmaceuticals announces US 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
2. Desmoda (desmopressin acetate). Desmoda.com. Accessed February 26, 2026. https://desmoda.com/#