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A Phase I/II First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

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Trial Profile

A Phase I/II First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of a Single Intravenous (IV) Administration of ECUR-506 in Males Less Than 9 Months of Age With Genetically Confirmed Neonatal Onset Ornithine Transcarbamylase (OTC) Deficiency

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Sep 2026

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At a glance

  • Drugs ECUR 506 (Primary)
  • Indications Ornithine carbamoyltransferase deficiency disease
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms OTC-HOPE
  • Sponsors iECURE

Most Recent Events

  • 27 Aug 2026 According to an iECURE media release, dosing has been completed across all dose cohorts.
  • 27 Aug 2026 According to an iECURE media release, status changed from recruiting to active, no longer recruiting.
  • 27 Aug 2026 According to an iECURE media release, company is presenting data from OTC-HOPE trial in an oral platform presentation at the Annual Symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Helsinki, Finland.

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