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GOV.UK (Medicines and Healthcare products Regulatory Agency)

MHRA and HRA agree a modified PATHWAYS protocol; recruitment not due until 1 August 2026 pending legal proceedings

Jun 19, 2026
Editorial illustration of protocol binders beside a Thames-side building

On 19 June 2026, the Medicines and Healthcare products Regulatory Agency said it had concluded scientific dialogue with the PATHWAYS sponsor and that a modified protocol met required regulatory standards. The Health Research Authority, in parallel, approved the trial against its ethical standards.

Still a trial, not a return of routine care. Routine NHS puberty blockers for this indication remain banned. The update does not reopen general clinic prescribing.

MHRA said the modified protocol includes strengthened safeguards (minimum ages of entry; clearer discontinuation measures for bone health, cognition, and vaginal bleeding; more detailed fertility-preservation information). Recruitment was not due to commence until 1 August 2026, due to legal proceedings. That 19 June update did not mean recruitment had already restarted.

Official source

- GOV.UK, 19 June 2026: Update on the PATHWAYS clinical trial

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