{"schema":"rootz.ai/sec-company/v1","layer":1,"cik":"0001710340","name":"Eton Pharmaceuticals, Inc.","summary":"Eton Pharmaceuticals is a rare disease pharmaceutical company focused on developing and commercializing treatments for rare diseases. It currently markets eight commercial products: INCRELEX, ALKINDI SPRINKLE, KHINDIVI, GALZIN, PKU GOLIKE, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The company also has five product candidates in late-stage development: ET-600, Amglidia, ET-700, ET-800, and ZENEO Hydrocortisone Autoinjector. Eton leverages the 505(b)(2) regulatory pathway and relies on third-party CMOs for manufacturing.","people":[],"products":[{"name":"INCRELEX","type":"service","description":"FDA-approved biologic for severe primary insulin-like growth factor 1 deficiency (SPIGFD) in children; approved in 40 territories."},{"name":"ALKINDI SPRINKLE","type":"service","description":"FDA-approved granule hydrocortisone for adrenocortical insufficiency in children under 17; first and only FDA-approved granule formulation."},{"name":"KHINDIVI","type":"service","description":"FDA-approved oral solution hydrocortisone for adrenocortical insufficiency in pediatric patients five years and older; ready-to-use liquid."},{"name":"GALZIN","type":"service","description":"FDA-approved maintenance treatment for Wilson disease patients previously treated with a chelating agent."},{"name":"PKU GOLIKE","type":"service","description":"Medical formula product for dietary management of phenylketonuria (PKU) using Physiomimic technology with taste-masked, odor-free coating."},{"name":"Carglumic Acid Tablets","type":"service","description":"FDA-approved generic version of Carbaglu for acute and chronic hyperammonemia due to NAGS deficiency."},{"name":"Betaine Anhydrous for Oral Solution","type":"service","description":"FDA-approved generic version of Cystadane for treatment of homocystinuria, a rare inherited condition."},{"name":"Nitisinone","type":"service","description":"FDA-approved generic version of Orfadin for treatment of tyrosinemia type 1, an ultra-rare inherited condition."},{"name":"ET-600","type":"service","description":"Product candidate for diabetes insipidus; NDA accepted by FDA with PDUFA goal date of February 25, 2026."},{"name":"Amglidia","type":"service","description":"Glyburide oral suspension in development for neonatal diabetes mellitus; approved by EMA in 2018, FDA Orphan Drug Designation granted."},{"name":"ET-700","type":"service","description":"Product candidate for Wilson disease; proof-of-concept PET study scheduled for 2026."},{"name":"ET-800","type":"service","description":"Ready-to-use injectable liquid hydrocortisone in a vial under development for the hospital market."},{"name":"ZENEO Hydrocortisone Autoinjector","type":"hardware","description":"Proprietary needle-free autoinjector under development for treatment of adrenal crisis."}],"partnerships":[{"partner_name":"AMMTeK","partnership_type":"licensing","description":"Licensing agreement granting Eton U.S. rights to Amglidia (glyburide oral suspension) for neonatal diabetes mellitus, signed November 2024.","start_date":null}],"affiliations":[],"origin":{"leaf":"2fca59c10bfbe4ab312f90591dabf7ab1ae9a70b8b6cc4e9df75040678d81ef9","formula":"v2: sha256( sha256(content) || parent || source_accession )","content_sha256":"fd43490dcf6347b42961f7a036e61dacc7547df79ddeae766a4fcd9c61571607","parent":"687d6dc2a767f5e50c8ed97508cd492d8f66e143685b3774382a73ed41e16903","source":"0001437749-26-009059","chain":"sec.gov/EDGAR (retrieved over TLS, accession recorded) > origin.rootz.global extraction > this response","registry":"origin.rootz.global","verify":"Recompute it: sha256(sha256(<this response body minus the origin block>) || parent || source_accession). 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