Gender-questioning children as young as 11 will be able to access puberty-blocking drugs in a planned clinical trial, sparking fury among campaigners who are taking legal action against the Government.
Background of the Trial
The Pathways Trial, approved by UK regulators and ethics experts in November 2025, aims to examine the impact of puberty blockers on the social, physical and emotional wellbeing of children under 16 who are questioning their gender. However, the trial was paused in February 2026 due to safety concerns and the absence of a minimum age.
The Medicines and Healthcare products Regulatory Agency (MHRA) suggested introducing a minimum age of 14. In the new proposals, safeguards including participation age were strengthened after discussions with the research team. Yet the new age limits are much lower: 11 for birth-registered females and 12 for birth-registered males.
Legal and Ethical Concerns
Some doctors have questioned whether the trial is necessary, while campaigners are taking legal action against the MHRA, the Government and those involved. Children will need parental consent, but critics argue that children cannot give fully informed consent to a treatment that may impact their future fertility.
Researchers from King's College London have agreed not to recruit participants until after August 1 to allow legal proceedings to take place. Children must also meet criteria including “demonstrating a good understanding of the intervention and its possible benefits and risks”.
Researchers said they “always welcome scrutiny” of studies involving children and young people and had strengthened patient information, but there were “no major changes to the design or conduct” of the trial. New guidance on when to stop the drugs includes concerns around bone density, impact on brain function or vaginal bleeding. Individuals will be provided information on how to preserve their fertility.
Regulatory History
The NHS stopped routine prescription of puberty blocker treatments to under-18s in March 2024 following the Cass Review into gender identity services. The drugs were then banned in December 2024 after a consultation found an “unacceptable safety risk”. The legislation was set to be reviewed in 2027.
Dr Hilary Cass, author of the independent review, said in 2024: “Puberty blockers are powerful drugs with unproven benefits and significant risks.” She recommended they only be prescribed following a multi-disciplinary assessment. She has since told the BBC it is “vital” that the trial for under-16s goes ahead, or “we're going to have ongoing charlatans just handing out inappropriate drugs,” referring to unregulated sales.
