Drug Profile

Fumarylacetoacetate hydrolase gene therapy - Castle Creek Pharmaceuticals

Alternative Names: Fumarylacetoacetate hydrolase gene therapy

Latest Information Update: 28 Feb 2026

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At a glance

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Tyrosinaemia type I
New Molecular Entity No

28 Feb 2026 No recent reports of development identified for preclinical development in Tyrosinaemia-type-I in USA (Parenteral)
25 May 2022 Castle Creek Biosciences announces it intention to submit an IND application to US FDA for Tyrosinaemia type I
25 Jan 2022 Preclinical trials in Tyrosinaemia type I in USA (Parenteral) (Castle Creek Pharmaceuticals pipeline, January 2022)

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