A challenge to the regulatory approval of the PATHWAYS Trial has beenrejected by the High Courtthis afternoon. PATHWAYSis a programme of research aiming to help find out how the NHS can better support children and young people with gender incongruence. As part of the programme an application forPATHWAYS Trial, a Clinical Trial of an Investigational Medicine Product (CTIMP) investigating the effects of puberty-suppressing medication on young people's physical, social and emotional wellbeing,received a favourable opinion in November 2025. The approval was given via theCombined Reviewprocess, where both the HRA andMedicine and Healthcare products Regulatory Agency(MHRA) review applications for CTIMPs in parallel, and provide a single combined
UK Health Research Authority · July 31, 2026
UK HRA: Legal challenge to PATHWAYS Trial approval rejected by High Court
Original title: Our response to the outcome of a legal challenge of the PATHWAYS Trial
High Court rejected a legal challenge to HRA and MHRA approval of the PATHWAYS Trial, a clinical trial of puberty-suppressing medication in young people with gender incongruence.
Published by UK Health Research Authority. HealthSignal links to the original document; the summary above is extracted from the source text.