Eton Pharmaceuticals Announces Positive Pivotal Clinical Study Results for Product Candidate ET-600
Eton Pharmaceuticals (ETON) has announced positive results from its bioequivalence study for ET-600, a patented oral solution of desmopressin designed to treat central diabetes insipidus. The pivotal study, involving 75 human subjects, demonstrated pharmacokinetic equivalence to the FDA-approved reference product.
The study was conducted as an open label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover oral bioequivalence study. Following these successful results, Eton plans to submit a New Drug Application (NDA) to the FDA in April 2025.
If approved, ET-600 would become the only FDA-approved oral liquid formulation of desmopressin, particularly beneficial for pediatric patients requiring precise and titratable doses. The company anticipates a potential commercial launch in the first quarter of 2026.
Eton Pharmaceuticals (ETON) ha annunciato risultati positivi dal suo studio di bioequivalenza per ET-600, una soluzione orale brevettata di desmopressina progettata per trattare il diabete insipido centrale. Lo studio cruciale, che ha coinvolto 75 soggetti umani, ha dimostrato equivalenza farmacocinetica rispetto al prodotto di riferimento approvato dalla FDA.
Lo studio è stato condotto come uno studio di bioequivalenza orale in aperto, bilanciato, randomizzato, a dose singola, con tre trattamenti, tre sequenze, tre periodi e crossover a tre vie. Dopo questi risultati positivi, Eton prevede di presentare una Domanda di Nuovo Farmaco (NDA) alla FDA nell'aprile del 2025.
Se approvato, ET-600 diventerebbe l'unica formulazione liquida orale di desmopressina approvata dalla FDA, particolarmente vantaggiosa per i pazienti pediatrici che necessitano di dosi precise e titolabili. L'azienda prevede un possibile lancio commerciale nel primo trimestre del 2026.
Eton Pharmaceuticals (ETON) ha anunciado resultados positivos de su estudio de bioequivalencia para ET-600, una solución oral patentada de desmopresina diseñada para tratar la diabetes insípida central. El estudio clave, que involucró a 75 sujetos humanos, demostró equivalencia farmacocinética con el producto de referencia aprobado por la FDA.
El estudio se llevó a cabo como un estudio de bioequivalencia oral abierto, equilibrado, aleatorizado, de dosis única, con tres tratamientos, tres secuencias, tres períodos y un cruce de tres vías. Tras estos resultados exitosos, Eton planea presentar una Solicitud de Nuevo Medicamento (NDA) a la FDA en abril de 2025.
Si se aprueba, ET-600 se convertiría en la única formulación líquida oral de desmopresina aprobada por la FDA, especialmente beneficiosa para los pacientes pediátricos que requieren dosis precisas y titrables. La empresa anticipa un posible lanzamiento comercial en el primer trimestre de 2026.
이튼 제약(Eton Pharmaceuticals, ETON)은 중앙성 요붕증 치료를 위해 설계된 ET-600의 생물학적 동등성 연구에서 긍정적인 결과를 발표했습니다. 75명의 인간 피험자가 참여한 이 주요 연구는 FDA에서 승인된 기준 제품과의 약리학적 동등성을 입증했습니다.
이 연구는 공개 라벨, 균형 잡힌, 무작위, 단일 용량, 세 가지 치료, 세 가지 순서, 세 가지 기간, 세 가지 경로의 교차 생물학적 동등성 연구로 수행되었습니다. 이러한 성공적인 결과에 따라, 이튼은 2025년 4월에 FDA에 신약 신청서(NDA)를 제출할 계획입니다.
승인될 경우, ET-600은 FDA에서 승인된 유일한 구강 액체 제형의 데스모프레신이 되어, 정밀하고 조절 가능한 용량이 필요한 소아 환자에게 특히 유익할 것입니다. 회사는 2026년 1분기에 상업적 출시를 예상하고 있습니다.
Eton Pharmaceuticals (ETON) a annoncé des résultats positifs de son étude de bioéquivalence pour ET-600, une solution orale brevetée de desmopressine conçue pour traiter le diabète insipide central. L'étude pivot, impliquant 75 sujets humains, a démontré une équivalence pharmacocinétique par rapport au produit de référence approuvé par la FDA.
L'étude a été réalisée en tant qu'étude de bioéquivalence orale ouverte, équilibrée, randomisée, à dose unique, avec trois traitements, trois séquences, trois périodes et un croisement à trois voies. Suite à ces résultats positifs, Eton prévoit de soumettre une Demande de Nouveau Médicament (NDA) à la FDA en avril 2025.
Si elle est approuvée, ET-600 deviendrait la seule formulation liquide orale de desmopressine approuvée par la FDA, particulièrement bénéfique pour les patients pédiatriques nécessitant des doses précises et titrables. L'entreprise anticipe un lancement commercial potentiel au premier trimestre de 2026.
Eton Pharmaceuticals (ETON) hat positive Ergebnisse aus seiner Bioäquivalenzstudie für ET-600, eine patentierte orale Lösung von Desmopressin zur Behandlung von zentralem Diabetes insipidus, bekannt gegeben. Die entscheidende Studie, an der 75 menschliche Probanden teilnahmen, zeigte eine pharmakokinetische Äquivalenz zu dem von der FDA zugelassenen Referenzprodukt.
Die Studie wurde als offene, ausgewogene, randomisierte, Einzeldosis-, Dreibehandlungs-, Dreisequenz-, Dreiperioden- und Dreifach-Crossover-Bioäquivalenzstudie durchgeführt. Nach diesen erfolgreichen Ergebnissen plant Eton, im April 2025 einen Neuen Arzneimittelantrag (NDA) bei der FDA einzureichen.
Wenn genehmigt, würde ET-600 die einzige von der FDA zugelassene orale Flüssigformulierung von Desmopressin werden, die besonders vorteilhaft für pädiatrische Patienten ist, die präzise und titrierbare Dosen benötigen. Das Unternehmen erwartet einen möglichen Markteintritt im ersten Quartal 2026.
- Successful completion of pivotal bioequivalence study with positive results
- ET-600 would be the only FDA-approved oral liquid desmopressin formulation if approved
- Clear pathway to NDA submission in April 2025
- Potential market entry in Q1 2026
- FDA approval still pending and not guaranteed
- Commercial success dependent on market adoption and competition
- Company’s patented desmopressin oral solution successfully passed pivotal bioequivalence study -
- Company expects to submit New Drug Application (NDA) in April 2025 -
DEER PARK, Ill., March 14, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today 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.
In a bioequivalence study conducted in 75 human subjects, ET-600 demonstrated pharmacokinetic equivalence to the U.S. Food and Drug Administration (FDA)-approved reference product of the same active ingredient. Healthy adults enrolled in the study were randomly assigned to receive the test and reference drug in an open label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover oral bioequivalence study. Based on these successful trial results, Eton anticipates submitting an NDA to the FDA for ET-600 in April 2025. If approved, ET-600 would be the only FDA-approved oral liquid formulation of desmopressin.
“We are pleased to see ET-600 pass its pivotal study and move one step closer to reaching patients. Through our deep relationships in the pediatric endocrinology community, we've come to appreciate the significant need for a desmopressin medication that can accommodate the precise and titratable doses necessary for pediatric patients. We expect to submit the NDA shortly and have begun pre-launch commercial readiness activities in anticipation of a potential launch in the first quarter of 2026,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
About ET-600
ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidus. The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under revise by the United States Patent and Trademark Office. Central diabetes insipidus is estimated to impact approximately 3,000 pediatric patients in the United States.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Relations:
Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
Source: Eton Pharmaceuticals, Inc.
FAQ
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