TheraCryf plc (AIM: TCF), a biotechnology company developing new medicines for addiction and other neuropsychiatric disorders, revealed on Monday that it has completed the Good Manufacturing Practice (GMP) production of over 2kg of clinical-grade drug substance for its lead orexin-1 (Ox-1) receptor antagonist, marking a key milestone in advancing the programme towards human trials.

The company confirmed that 2.57kg of material suitable for clinical use has been produced, exceeding yield expectations and delivered three weeks ahead of schedule. The batch meets regulatory standards for human use and supports the planned Phase 1 study, enabling a transition from preclinical development without manufacturing-related delays.

TheraCryf plc stated that the successful scale-up and first-pass quality achievement demonstrate the robustness and scalability of its manufacturing process, which is subject to a recent patent filing. The drug substance will now be formulated into the final product for administration in Phase 1 volunteers.

Completion of the remaining preclinical package, including 28-day toxicology studies, is on track for Q3 2026, supporting regulatory submissions for first-in-human trials within the year.

The Ox-1 programme targets substance use disorders, a market projected to exceed USD70bn by 2035, where demand remains high for effective, non-addictive therapies. TheraCryf plc continues to advance its pipeline under a capital-light model, focusing on early clinical development ahead of potential partnering opportunities.