Overview
- The Medicines and Healthcare products Regulatory Agency approved a modified Pathways protocol on Friday that introduces strengthened safeguards and minimum entry ages of 11 for birth-registered females and 12 for birth-registered males.
- Researchers at King’s College London said they have improved patient information and that the trial’s core design is unchanged as it prepares to recruit about 226 young people to study the timing and effects of puberty suppression.
- The MHRA originally paused the study in February and asked for a higher lower age after raising concerns about unquantified long-term biological risks such as effects on bone density and fertility.
- A campaign group and two individuals have launched judicial review proceedings challenging the trial’s approvals, and the MHRA says no children are expected to be recruited before 1 August while the legal action proceeds.
- The Pathways trial was commissioned after the 2024 Cass Review found weak evidence for puberty blockers; its results are intended to inform NHS care and could shape future clinical and policy decisions about treatment for gender-questioning young people.