Trial Profile

Long Term Follow-Up and Collection of Historical Control Data on Menkes Disease Patients

Status: Recruiting

Phase of Trial: Phase IV

Latest Information Update: 09 Jan 2025

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At a glance

Drugs Copper histidine (Primary)
Indications Menkes kinky hair syndrome
Focus Registrational; Therapeutic Use
Sponsors Cyprium Therapeutics

Most Recent Events

06 Jan 2025 According to a Fortress Biotech media release, company announced the acceptance for review of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, based on positive topline clinical efficacy results for CUTX-101 from this trial.
28 Mar 2024 According to a Fortress Biotech media release, the CUTX-101 rolling NDA submission is ongoing and is expected to be completed by Sentynl in 2024.
26 Sep 2023 Planned End Date changed from 31 Dec 2022 to 31 Dec 2023.

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