Gender-questioning children as young as 11 will be able to access puberty-blocking drugs in a planned clinical trial. However, campaigners are taking legal action against the Government after puberty blockers, which delay or prevent puberty from happening, were banned for under-18s in 2024.
The Pathways Trial, approved by UK regulators and ethics experts in November 2025, aims to examine the impact of the drugs on the social, physical and emotional wellbeing of children under the age of 16 who are questioning their gender, and are currently accessing gender services. However, the trial was paused in February 2026 since there were safety concerns and no minimum age. The Medicines and Healthcare products Regulatory Agency (MHRA) suggested introducing a minimum age of 14.
In the new proposals, it said “a number of safeguards”, including participation age, were strengthened after discussions with the research team. However, the new age limits are much lower at 11 for birth-registered females, and 12 for birth-registered males.
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 have to get parental consent to take part in the trial, but they 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 will also need to meet criteria to be involved, which includes “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 that they had also strengthened patient information. But there were “no major changes to the design or conduct” of the trial.
There is also new guidance on when to stop the drugs, such as if there are concerns around bone density, impact on brain function or vaginal bleeding. Individuals will be provided information on how to preserve their fertility.
The drugs were then banned in December 2024 after a targeted consultation found there was an “unacceptable safety risk in the continued prescription of puberty blockers to children”. The legislationn 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 there were only prescribed following a multi-disciplinary assessment.
She has since told the BBC it is “vital” that the trial for puberty blockers for under-16s goes ahead, or “we’re going to have ongoing charlatans just handing out inappropriate drugs,” referring to unregulated sales.