On 20 February 2026, the Department of Health and Social Care confirmed that preliminary work to establish the PATHWAYS clinical trial on prescribing puberty‑suppressing hormones for children and young people with gender incongruence has been paused after the Medicines and Healthcare products Regulatory Agency (MHRA) raised new concerns. Recruitment will not begin until the issues identified by the regulator are resolved. (gov.uk)
King’s College London, the trial sponsor, will hold discussions with the MHRA next week. Ministers reiterated that the study can proceed only if expert scientific and clinical advice concludes it is both safe and necessary, with child safety the overriding consideration. (gov.uk)
The Health Research Authority (HRA) has stated that PATHWAYS is a Clinical Trial of an Investigational Medicinal Product (CTIMP) approved via the combined HRA Research Ethics Committee and MHRA route. If amendments to the protocol are required, the independent Research Ethics Committee will review its opinion before any restart, and the HRA will continue to work with the MHRA while concerns are addressed. (hra.nhs.uk)
According to materials published by King’s College London and the HRA, PATHWAYS is designed as a randomised controlled study comparing immediate initiation of gonadotropin‑releasing hormone analogue treatment with a 12‑month deferred start. The indicative protocol envisages up to 226 participants under 16, measuring outcomes across quality of life, mental health, physical development and cognitive function, alongside linked observational components (PATHWAYS CONNECT and HORIZON). The study is co‑sponsored by King’s College London and South London and Maudsley NHS Foundation Trust and funded through the National Research Collaboration Programme, a partnership between NHS England and the NIHR. (hra.nhs.uk)
The pause sits within a policy environment in which routine access to puberty‑suppressing hormones for under‑18s in England has been removed. NHS England’s clinical policy, first published on 12 March 2024, states these medicines are not commissioned outside research. Separately, government regulations made indefinite from December 2024 restrict private prescribing and supply of puberty blockers to under‑18s, with limited exemptions. (england.nhs.uk)
For NHS services, the immediate effect is that there is currently no active recruitment route for new patients to receive puberty‑suppressing hormones within research, while routine prescribing remains unavailable. Providers should continue delivering psychosocial support through the reconfigured regional Children and Young People’s Gender Services established from April 2024, pending any revised protocol and approvals. (gov.uk)
No timeframe has been set for recruitment to begin. The HRA has confirmed the study will be re‑reviewed in line with standard operating procedures before any restart, and that amendments triggered by the MHRA’s scientific dialogue with the sponsor will require further ethics and regulatory scrutiny. (hra.nhs.uk)
Operationally, any change to eligibility or trial conduct will be communicated through the usual regulatory channels. Until then, commissioning and clinical teams should plan on the basis that access to puberty‑suppressing hormones remains research‑only and paused, with the wider Cass Review implementation work across children’s gender services continuing in parallel. (hra.nhs.uk)