---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-25-013227"
form_type: "8-K"
ticker: "ETON"
cik: "0001710340"
company_name: "Eton Pharmaceuticals, Inc."
filed_at: "2025-04-28T23:59:59+00:00"
generated_at: "2026-05-23T05:03:32.257704+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Eton Pharmaceuticals submits NDA for ET-600 (desmopressin oral solution) for central diabetes insipidus

## Summary
- FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.
- Expected 10-month FDA review; potential approval and launch in Q1 2026.
- Patent expires in 2044; bioequivalence study in 75 subjects demonstrated PK equivalence to reference product.
- Estimated 3,000 pediatric patients in the U.S. with central diabetes insipidus.
- Pre-launch commercial activities underway; CEO cites strong physician demand for titratable pediatric dosing.

## SEC filing metadata
- accession: 0001437749-25-013227
- form_type: 8-K
- ticker: ETON
- cik: 0001710340
- company_name: Eton Pharmaceuticals, Inc.
- filed_at: 2025-04-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710340/000143774925013227/0001437749-25-013227-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710340/000143774925013227/eton20250326_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-25-013227
- JSON: https://secwatch.observer/filing/0001437749-25-013227.json
- Plain text: https://secwatch.observer/filing/0001437749-25-013227.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.