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Regulators approve first trials for puberty-blocking drugs in children since ban

The trial will enroll around 220 under-16s to assess puberty blockers’ effects on wellbeing, brain development, and fertility, addressing a major evidence gap, researchers said.

  • On Friday, UK regulators approved and launched the first clinical trials of puberty‑blocking drugs since last year’s ban, with King's College London researchers expecting recruitment early next year for the PATHWAYS Trial.
  • The Cass review and a sharp rise in referrals drove the decision to commission PATHWAYS as Dr Hilary Cass found poor evidence for hormone treatments amid NHS gender services referrals surging to more than 5,000 by 2022.
  • The PATHWAYS Trial will recruit around 250 children under 16 and randomise eligible young people to immediate treatment or a 12-month delayed start, following both groups for two years.
  • Campaigners including Keira Bell have vowed legal challenges to halt recruitment, while doctors' groups warned of harms including bone loss and brain effects; researchers say some participants might continue treatment after the trial.
  • The PATHWAYS research programme, �10.7 million, aims to inform NHS practice and policy for children attending gender services with initial results in around four years.
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GB News broke the news in London, United Kingdom on Friday, November 21, 2025.
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