Trial Profile

A registrational pivotal trial program of Cenegermin-bkbj for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 14 Nov 2025

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At a glance

14 Nov 2025 New trial record
15 Oct 2025 According to Dompe farmaceutici media release, this registrational pivotal trial program is planned in more than 130 sites across 16 countries.
15 Oct 2025 According to Dompe farmaceutici media release, company announced selection by the United States Food and Drug Administration (FDA) to participate in the Commissioner National Priority Voucher (CNPV) program that shortened review timeline for marketing application and enhanced collaboration with the FDA. Company intends to apply the voucher for the Biologic License Application (BLA) for an intranasal Cenegermin-bkbj for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION).

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