Eton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval as a replacement therapy for children aged five years and above with adrenocortical insufficiency.
This rare condition is characterised by the adrenal glands’ failure to produce adequate levels of cortisol.
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Khindivi is the sole FDA-approved hydrocortisone oral solution and is available in a 1mg/ml concentration.
This formulation is particularly beneficial as it removes the necessity of splitting or crushing tablets, providing precise dosing in a ready-to-use liquid solution that does not require mixing, shaking or refrigeration.
The product is designed to be suitable for those who struggle with swallowing pills or have specific administration needs, such as a gastric tube.
The company’s current team of paediatric endocrinology rare disease specialists will promote the oral solution.
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By GlobalDataKhindivi will soon be available in the country via speciality pharmacy Anovo that caters to patients with rare and chronic conditions.
Khindivi is not approved for increased dosing at times of stress or acute events.
Eton also markets Alkindi Sprinkle, another FDA-approved hydrocortisone treatment for paediatric adrenocortical insufficiency.
Eton Pharmaceuticals CEO Sean Brynjelsen stated: “The FDA approval of Khindivi is a tremendous achievement for Eton and more importantly, a pivotal step forward for paediatric patients with adrenal insufficiency. As a home-grown programme, our team expertly navigated the development, clinical and regulatory pathway.
“Being in a position to commercialise Khindivi within days of this approval is a further testament to the executional excellence from our entire company.”
In February 2025, the company secured a patent from the US Patent and Trademark Office for the desmopressin oral solution formulation of its ET-600 product candidate for the treatment of diabetes insipidus.
