The Department of Health and Social Care (DHSC) confirmed on 20 February 2026 that preliminary work to establish the PATHWAYS clinical trial into the prescription of puberty‑suppressing hormones for children and young people has been paused after the Medicines and Healthcare products Regulatory Agency (MHRA) raised new concerns. The department stated the trial will proceed only if expert scientific and clinical advice concludes it is both safe and necessary. (gov.uk)
DHSC said scientific discussions between the MHRA and the sponsor, King’s College London, will begin in the week commencing 23 February 2026. Until the issues raised by the regulator are resolved with the trial clinicians, recruitment will not start. (gov.uk)
According to the Health Research Authority (HRA), PATHWAYS is a Clinical Trial of an Investigational Medicinal Product (CTIMP) approved via the combined review route by the HRA, an independent Research Ethics Committee and the MHRA. With the study paused, the HRA will review the trial again-consistent with standard operating procedures-before any restart, and will consider any amendments arising from the regulator’s dialogue. (hra.nhs.uk)
Public HRA documentation indicates the trial planned to enrol 226 participants under 16 who are eligible for gonadotropin‑releasing hormone analogues, randomly assigning them to begin treatment immediately or after a 12‑month delay, with outcomes assessed over two years and extended follow‑up. The research is funded by the National Institute for Health and Care Research and NHS England, co‑sponsored by King’s College London and South London and Maudsley NHS Foundation Trust, with recruitment through NHS children’s gender services. (hra.nhs.uk)
King’s College London’s study materials set out independent oversight via a Data Monitoring Committee and a Programme Steering Committee with lay representation, alongside prior regulatory and ethics approvals. These governance features remain relevant as the sponsor engages with the MHRA on any required protocol changes. (kcl.ac.uk)
The pause sits within a wider policy framework. NHS England confirmed on 12 March 2024 that puberty‑suppressing hormones are not routinely commissioned for under‑18s and that access, where clinically appropriate, should proceed only within clinical research. Separately, on 11 December 2024 the government made indefinite an order prohibiting the sale and supply of these medicines to under‑18s via private prescriptions, while preserving exemptions including clinical trials and other indications. Together, this means properly authorised research remains the route for any new access. (gov.uk)
Regulatory timelines also matter. The MHRA and HRA have signalled changes to UK clinical trials regulation taking effect on 28 April 2026, including mandatory public registration and results reporting and a more proportionate system for reviewing substantial modifications. Any changes emerging from the current dialogue would require Research Ethics Committee approval and regulator sign‑off before recruitment can begin. (gov.uk)
For clinicians and families, practice remains unchanged. Routine prescribing in NHS England is unavailable and private supply is restricted; the planned trial will not admit participants until the MHRA’s concerns are addressed and approvals reconfirmed. DHSC has reiterated that the safety and wellbeing of children and young people are the determining considerations. (gov.uk)