MHRA Agrees New Safeguards for Pathways Puberty‑Blocker Trial

Regulators and researchers have set minimum entry ages and tougher monitoring, but legal challenges and a delayed recruitment start will decide whether the study proceeds.

Overview

On 19 June the Medicines and Healthcare products Regulatory Agency approved a modified Pathways protocol that adds minimum ages for entry and clearer rules for stopping treatment.
King’s College London said it will not recruit any children before 1 August 2026 while a High Court challenge to the trial’s ethical approval is scheduled for 27 July 2026.
The revised rules require parental consent, more than 13 hours of medical assessments, about 50 forms, and monitoring for bone health, cognition and fertility preservation.
NHS England data obtained by the Press Association show 4,079 children on waiting lists for specialist gender services at the end of March 2026, including around 260 primary‑school aged children and at least one aged six or younger.
Puberty blockers remain banned on the NHS for gender dysphoria outside research settings since 2024, and ministers say the trial’s results will shape future NHS policy depending on regulatory, judicial and parliamentary outcomes.