The UK High Court has rejected a legal challenge brought by campaigners seeking to stop the Pathways clinical trial, which will assess the benefits or risks of puberty blockers in children.
The trial, run by researchers at King's College London (KCL), will begin recruiting more than 220 children aged between 11 and 16 from 1 August. It was commissioned following a 2024 review of gender services by Baroness Hilary Cass, which found evidence for treating young people with puberty blockers was 'remarkably weak'.
The number of children the Pathways trial aims to recruit.
Mr Justice Chamberlain refused the application for a judicial review, stating that none of the campaigners' claims had a realistic chance of success. The Bayswater Support Group, which works with 800 parents, had brought legal action claiming the trial was unethical and children could not give properly informed consent. The group said the trial 'raise fundamental questions about whether the protective framework for minors has been properly implemented'.
It's a tragedy that the court has refused permission for this challenge to proceed.
The UK government has banned the use of puberty blocking drugs in children's gender care. The ban allows children already on medication to continue, but new prescriptions can reportedly only be offered as part of a controlled clinical trial. The Pathways trial, commissioned by NHS England, aims to establish scientific evidence regarding possible health risks and benefits.
KCL researchers reportedly hope to recruit 226 children under the age of 16 in England who have a diagnosis of 'gender incongruence'. The trial will examine the effects of puberty blockers on bone density, brain development, fertility, and mental wellbeing. Each patient will be assessed over 'many months' by specialist doctors to determine if they have a reasonable prospect of clinical benefit.
The UK medicines regulator, the MHRA, reportedly suggested a minimum age of 14 for the trial due to safety concerns in February 2026. Following discussions with researchers, the MHRA announced that girls can participate from age 11 and boys from age 12. The trial design has been approved by the UK's health research regulators, the HRA and MHRA.
The trial is 'essential' to determine if these drugs are helpful.
