FDA Approves Eton Pharma's Oral Drug For Adrenal Insufficiency In Pediatric Patients, Analyst Sees Boost In 2025 Revenue

The U.S. Food and Drug Administration (FDA) approved Eton Pharmaceuticals, Inc.’s ETON new drug application (NDA) for Khindivi (hydrocortisone) oral solution as a replacement therapy for pediatric patients five years of age and older with adrenocortical insufficiency.

Adrenocortical insufficiency, also known as adrenal insufficiency, is when the adrenal glands don’t produce enough hormones, particularly glucocorticoids (like cortisol) and mineralocorticoids (like aldosterone). 

Also Read: Eton Pharma Plans FDA Filing For ET-600 Oral Desmopressin Next Month, Eyes 2026 Launch

Cortisol helps break down fats, proteins and carbohydrates in the body.

Khindivi comes in a 1mg/ml strength designed to eliminate the need to split or crush tablets. It does not require refrigeration, mixing or shaking as it is a ready-to-use oral liquid solution.

Khindivi will be promoted by Eton’s existing team of pediatric endocrinology rare disease specialists. Eton currently commercializes FDA-approved Alkindi Sprinkle (hydrocortisone) oral granules for pediatric patients with adrenocortical insufficiency.

Eton estimates that there are more than 5,000 adrenal insufficiency patients in the U.S. between the ages of 5 and 17.

Khindivi will be available in the U.S. exclusively through Anovo, a specialty pharmacy.

The program provides prescription fulfillment, insurance benefits investigation, educational support, financial assistance for qualified patients and other services designed to help patients access treatment. Eton Cares will offer co-pay assistance to allow for zero-dollar co-pays for qualifying patients.

HC Wainwright writes that Khindivi could potentially become the hydrocortisone formulation of choice for patients with adrenal insufficiency and gain rapid adoption among caregivers and physicians.

Analyst Swayampakula Ramakanth projects Khindivi-associated revenues to grow to a peak of $28 million in 2030 from $3 million in 2025.

Analyst Ramakanth writes, “Based on management's strength in commercial execution to date we believe these additions could make 2025 a year of revenue inflection.”

On Thursday, the analyst raised the price target from $33 to $35, maintaining the Buy rating, accounting for the launch in June compared to the prior the beginning of 2Q25; raised peak penetration to 60% from the prior 40%, considering the ease of administration.

ETON Price Action: Eton Pharmaceuticals stock is down 4.83% at $19.11 at publication on Thursday

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