Eton Pharmaceuticals (ETON) FDA Approvals

Eton Pharmaceuticals' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Eton Pharmaceuticals (ETON). Over the past two years, Eton Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as KHINDIVI™, ET-700, DESMODA, and ET-600. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

KHINDIVI™ FDA Regulatory Timeline and Events

KHINDIVI™ is a drug developed by Eton Pharmaceuticals for the following indication: In pediatric patients five years of age and older with adrenocortical insufficiency. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - July 29,2026

• Drug: KHINDIVI™
• Announced Date: July 29, 2026
• Indication: In pediatric patients five years of age and older with adrenocortical insufficiency.

Announcement

Eton Pharmaceuticals, Inc announced that the Company’s new formulation of KHINDIVI (hydrocortisone) oral solution successfully showed bioequivalence to ALKINDI SPRINKLE (hydrocortisone) oral granules, the FDA-approved hydrocortisone granule formulation, and the Company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) requesting an expansion of the product’s label to include younger pediatric patients.

AI Summary

Eton Pharmaceuticals announced that its new KHINDIVI (hydrocortisone) oral solution successfully demonstrated bioequivalence to ALKINDI SPRINKLE, the FDA-approved hydrocortisone oral granule product. The company has submitted a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration seeking to expand KHINDIVI’s label to include younger pediatric patients.

KHINDIVI is currently approved as replacement therapy for children ages 5 and older with adrenocortical insufficiency, a rare condition in which the adrenal glands do not produce enough cortisol. The product is not approved for stress dosing or acute events. Safety concerns include hyperosmolarity, metabolic acidosis, gastrointestinal irritation, infection risk, growth delays, and other effects linked to corticosteroid use or inactive ingredients. FDA review of the proposed label expansion is pending.

FDA approved - May 29,2025

NDA

• Drug: KHINDIVI™
• Announced Date: May 29, 2025
• Indication: In pediatric patients five years of age and older with adrenocortical insufficiency.

Announcement

Eton Pharmaceuticals announced that The U.S. Food and Drug Administration (FDA) approved 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.

AI Summary

Eton Pharmaceuticals announced that the FDA approved its new drug application for KHINDIVI™, an innovative hydrocortisone oral solution designed as replacement therapy for pediatric patients aged five years and older with adrenocortical insufficiency. KHINDIVI is the first and only FDA-approved oral solution of hydrocortisone, formulated at 1mg/ml to allow precise dosing without the need to split or crush tablets. Its ready-to-use liquid format eliminates the need for refrigeration, mixing, or shaking, which simplifies administration for children who may have trouble swallowing tablets or require gastric tube administration. This breakthrough approval is a major step forward in managing pediatric adrenal insufficiency, offering healthcare providers a reliable and convenient treatment option that can improve dosing accuracy and help ensure better clinical outcomes for affected children.

FDA Approval - May 28,2025

NDA

• Drug: KHINDIVI™
• Announced Date: May 28, 2025
• Indication: In pediatric patients five years of age and older with adrenocortical insufficiency.

Announcement

Eton Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency.

AI Summary

Eton Pharmaceuticals recently received FDA approval for its New Drug Application for KHINDIVI™ (hydrocortisone) Oral Solution. This milestone product is the first and only FDA‐approved hydrocortisone liquid formulation for use as replacement therapy in pediatric patients aged five and older with adrenocortical insufficiency. Unlike tablets, KHINDIVI is a ready-to-use solution that comes in a 1mg/ml strength, eliminating the need to split or crush pills. Its design allows for simple, accurate dosing, making it especially useful for children who have difficulty swallowing or require administration via a gastric tube. This approval marks a significant advancement in pediatric care, offering a treatment option that can be tailored precisely to a child’s changing needs during a critical phase of growth and development.

ET-700 FDA Regulatory Events

ET-700 is a drug developed by Eton Pharmaceuticals for the following indication: Treatment Of Wilson Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Dose Update - April 27,2026

• Drug: ET-700
• Announced Date: April 27, 2026
• Indication: Treatment Of Wilson Disease

Announcement

Eton Pharmaceuticals, Inc announced the first patient has been dosed in a pilot clinical study assessing the efficacy of ET-700, the Company's proprietary, patent-pending formulation of extended-release zinc acetate under development for the treatment of Wilson disease.

AI Summary

Eton Pharmaceuticals announced the first patient has been dosed in a pilot clinical study of ET-700, the company’s proprietary, patent-pending extended-release zinc acetate being developed for Wilson disease. The study treatment period lasts four weeks and includes three groups. PET scans will assess intestinal copper absorption by measuring 64Cu in the liver. The primary endpoint is the change in mean hepatic 64Cu standard uptake value (SUV) from pre- to post-intervention between the three groups, as determined by two blinded investigators. The trial aims to see whether ET-700 can safely reduce copper uptake.

For context, zinc acetate (Galzin) is used for maintenance treatment in Wilson disease after initial chelation. Long-term zinc can cause copper deficiency and gastric ulcers, so patients require monitoring of copper and zinc levels, liver tests, and neuropsychiatric signs. Galzin should be taken on an empty stomach and capsules not opened or chewed.

DESMODA FDA Regulatory Events

DESMODA is a drug developed by Eton Pharmaceuticals for the following indication: central diabetes insipidus. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Approval - February 25,2026

NDA

• Drug: DESMODA
• Announced Date: February 25, 2026
• Indication: central diabetes insipidus

Announcement

Eton Pharmaceuticals, Inc announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for DESMODA™ (desmopressin acetate) Oral Solution for the management of central diabetes insipidus, also known as arginine vasopressin deficiency (AVP-D), as antidiuretic replacement therapy for patients of all ages.

AI Summary

Eton Pharmaceuticals announced FDA approval of DESMODA (desmopressin acetate) Oral Solution for management of central diabetes insipidus (AVP‑D) as antidiuretic replacement therapy. DESMODA is the first and only FDA‑approved oral desmopressin liquid. Supplied ready‑to‑use (0.05 mg/mL), it supports precise, individualized dosing without tablet splitting, crushing, refrigeration, mixing, or shaking.

Central diabetes insipidus is a rare condition from insufficient vasopressin; treatment needs careful titration to avoid under‑ or over‑treatment. Eton estimates more than 13,000 U.S. patients, including about 3,000–4,000 children, with expected peak sales of $30–50 million annually. A liquid formulation lets clinicians fine‑tune doses and adjust therapy as patient needs change.

DESMODA is indicated for adults and pediatric patients with central DI and should not be used for nephrogenic DI. Contraindications include hypersensitivity to desmopressin, moderate‑to‑severe renal impairment (CLcr <50 mL/min), or hyponatremia. Clinicians can e‑prescribe via Anovo #5 or fax 855‑813‑2039; more at desmoda.com.

ET-600 FDA Regulatory Timeline and Events

ET-600 is a drug developed by Eton Pharmaceuticals for the following indication: For the treatment of an endocrinology. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PDUFA Date - July 8,2025

NDA

• Drug: ET-600
• Announced Date: July 8, 2025
• Target Action Date: February 25, 2026
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.

AI Summary

Eton Pharmaceuticals announced that its New Drug Application (NDA) for ET-600, a new formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026, for this application. This milestone brings the company one step closer to offering a treatment aimed at addressing significant dosing challenges in pediatric patients with central diabetes insipidus. ET-600, which holds patent protection until 2044, is designed to provide a reliable oral liquid option, reducing the current need for caregivers to adjust or use unapproved doses. Eton's preparation for a potential market launch in early 2026 reflects its commitment to developing innovative treatments for rare diseases.

FDA review - July 8,2025

NDA

• Drug: ET-600
• Announced Date: July 8, 2025
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the U.S. Food and Drug Administration (FDA)

AI Summary

Eton Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for ET-600, a proprietary desmopressin oral solution. The FDA has also assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026 for this review. If approved, ET-600 will be the only oral liquid option on the market, offering a safer and more accurate dosing method for pediatric patients with central diabetes insipidus (arginine vasopressin deficiency). This new formulation has strong patent protection extending through 2044, ensuring its market exclusivity. The company is preparing for the potential launch of ET-600 in early 2026, aiming to address a significant unmet need in pediatric endocrinology by offering caregivers a reliable, titratable, and approved dosage form.

FDA review - April 28,2025

• Drug: ET-600
• Announced Date: April 28, 2025
• Target Action Date: Q1 2026
• Estimated Target Date Range: January 1, 2026 - March 31, 2026
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced that The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2026.

AI Summary

Eton Pharmaceuticals recently submitted a New Drug Application (NDA) to the FDA for ET-600, a treatment for central diabetes insipidus. The company expects that the FDA will assign a 10-month review period to this application. This timeline could lead to a potential FDA approval and a commercial launch in the first quarter of 2026.

If approved, ET-600 would become the only FDA-approved oral liquid formulation of desmopressin, offering the small, precise doses needed for pediatric patients. Eton is already preparing for the launch, working closely with leading pediatric endocrinologists to meet the treatment needs of children affected by this condition. The company’s preparations reflect its commitment to improving treatment options for rare diseases.

Application Submitted - April 28,2025

NDA

• Drug: ET-600
• Announced Date: April 28, 2025
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, Eton's proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

AI Summary

Eton Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, the company’s proprietary, patented oral solution of desmopressin. ET-600 is being developed to treat central diabetes insipidus, a condition affecting thousands of pediatric patients. The NDA review is expected to take 10 months, with a potential launch of the product in the first quarter of 2026 if approved. This submission marks an important step toward providing a unique, precise oral liquid formulation to meet the specific dosing needs of children with this rare disease. Pre-launch commercial activities are already underway as the company prepares for regulatory decisions.

Positive Results - March 14,2025

• Drug: ET-600
• Announced Date: March 14, 2025
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

AI Summary

Eton Pharmaceuticals recently announced that ET-600, its patented oral solution of desmopressin for treating central diabetes insipidus, met key bioequivalence criteria. In a study with 75 healthy adults, the drug demonstrated that it performs similarly to the FDA-approved reference product. The trial used a randomized, open-label, three-way crossover design to compare the pharmacokinetics of ET-600 with the standard treatment, showing that the experimental formulation is equivalent in delivering the active ingredient.

Based on these promising results, the company plans to submit a New Drug Application to the FDA in April 2025. If approved, ET-600 will be the only FDA-approved oral liquid formulation of desmopressin, offering a potentially more precise and titratable option, especially beneficial for pediatric patients who require careful dose adjustments.

Provided Update - February 7,2025

• Drug: ET-600
• Announced Date: February 7, 2025
• Indication: For the treatment of an endocrinology

Announcement

Eton Pharmaceuticals, Inc announced that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 12,214,010, covering its ET-600 product candidate's proprietary formulation of desmopressin oral solution.

AI Summary

Eton Pharmaceuticals announced that the USPTO granted U.S. Patent No. 12,214,010 for its ET-600 product candidate. This patent covers the company’s proprietary formulation of desmopressin oral solution, a treatment being developed for diabetes insipidus. The patent is set to expire in 2044, ensuring long-term protection for the innovative formulation.

The ET-600 formulation is specially designed to address the needs of pediatric patients who require small, precise, and titratable doses. Currently, desmopressin is only available in injectable, tablet, or nasal forms, with many children relying on less optimal compounded liquid suspensions or fractional tablet doses. Once approved by the FDA, the product is expected to be listed in the FDA Orange Book, further recognizing its importance and supporting its future market presence.