The NHS has paused new prescriptions of puberty blockers for transgender young people after the PATHWAYS clinical trial, run by King’s College London, was put on hold by regulators.
Why the trial stopped
The Medicines and Healthcare products Regulatory Agency (MHRA) asked for a temporary suspension after preparatory reviews flagged concerns about governance, safety oversight and some clinical procedures in the PATHWAYS study. The Department of Health and Social Care says regional children and young people’s gender services will continue to offer psychosocial and mental-health support, but there is currently no NHS route to begin the medications under investigation while the issues are worked through.
What regulators want
MHRA reviewers have asked investigators for clearer justification when enrolling biologically healthy adolescents, stronger risk assessments, and tightened consent procedures for younger participants. They have also made independent safety oversight and transparent reporting prerequisites for any restart. Investigators must explain how amended eligibility criteria will be monitored and audited, and spell out stopping rules and escalation pathways for adverse events.
Responses from clinicians and advocates
Many clinicians support careful scrutiny but want practical assurances that young people’s care won’t be disrupted. Advocacy groups are calling for transparency about long-term follow-up, data-sharing and how families will be informed of risks. Trial managers say they are in active discussions with regulators to revise the protocol; until MHRA’s concerns are addressed, the suspension remains in place.
Arguments over prescribing and consistency
Some clinicians argue the pause risks politicising clinical judgment. They point out that the same drugs are prescribed under established protocols for conditions such as precocious puberty, and say a controlled trial to study outcomes in adolescents with gender dysphoria was a reasonable next step. Others insist that treating developmentally typical adolescents for gender dysphoria requires distinct evidence and safeguards, and that trial design should explicitly address differences in diagnosis, natural history and risk–benefit balance.
Practical consequences for families
For many young people and their families the pause is immediate and unsettling. NHS sources say existing patients in local services will continue to receive care, but the PATHWAYS trial had been the main public route to start new prescriptions—so some people now face waits or the prospect of seeking private treatment. Clinics are reviewing eligibility criteria and psychological assessment procedures; some have tightened thresholds, others have paused new starts entirely.
NHS services and ongoing support
The NHS has reiterated that regional gender services will maintain holistic care focused on counselling, family support and non-pharmacological approaches while PATHWAYS is paused. Clinicians warn, however, that delays to pharmacological options can increase distress and complicate care planning for some adolescents and their families.
Next steps
MHRA and the trial team are negotiating protocol amendments, which may include enhanced consent protocols, independent audit mechanisms and clearer monitoring plans. The trial can only resume once regulators are satisfied these safeguards are in place and ethics approvals are renewed. The outcome will shape whether routine NHS prescribing pathways for puberty suppression can safely restart and how services are organised going forward. The coming weeks and months will be critical as investigators, regulators and clinicians try to reach an arrangement that protects participants while allowing research—and clinical practice—to move forward.