Business
Successful GMP Manufacture Advances Ox-1 to Clinic
TheraCryf plc has successfully manufactured over 2kg of its lead asset, Ox-1 receptor antagonist, to Good Manufacturing Practice (GMP) standard, producing 2.57kg of human-grade material three weeks ahead of schedule. This achievement, which confirms the scalability and robustness of their optimized manufacturing process, enables the company to advance towards Phase 1 clinical trials without program delays. The successful GMP manufacture further de-risks the program, which targets the substantial substance use disorder market projected to exceed $70 billion by 2035, and supports the planned Q3 2026 completion of the preclinical package for regulatory submission. Disclaimer*
About this update from Theracryf Plc
20 April 2026 TheraCryf plc ("TheraCryf", the "Company" or the "Group") Lead Asset Ox-1 Advances Towards Clinic With Successful GMP Manufacture For Human Use Over 2kg of clinical-grade material produced to support Phase 1 trials TheraCryf plc (AIM: TCF), the biotech company developing new medicines for addiction and other neuropsychiatric disorders, today announces the successful manufacture of over 2kg of drug substance for its lead orexin-1 (Ox-1) receptor antagonist to Good Manufacturing Practice (GMP) standard. Generating human-grade material that meets regulatory standards is the vital next step following the Company's manufacturing update on 5 January 2026. As planned, this latest product batch is suitable for use in human clinical trials. This critical milestone enables a seamless transition from preclinical to clinical activity, allowing initiation of dosing in humans after approval to conduct the Phase 1 study, without introducing programme delays due to further manufacturing. TheraCryf's manufacturing partner successfully produced 2.57kg of human-grade drug substance in an efficient process with a higher yield than anticipated, delivering three weeks ahead of schedule and confirming the scalability and robustness of the Company's optimised manufacturing process, which is the subject of a recent patent filing. Efficient GMP manufacturing is often a key bottleneck in drug development, leading to delays and higher product costs. In contrast, TheraCryf's Ox-1 antagonist has been successfully manufactured at scale, with clinical trial material meeting all required quality standards on first pass, supporting the planned Phase 1 study in human volunteers. This demonstrates strong process reliability, further de-risking the programme as it advances towards clinic readiness. The drug substance is now ready for formulation into the final drug product that will be given to the Phase 1 volunteers. Completion of the preclinical package, including delivery of the 28-day toxicology study results, the final step to enable a regulatory submission and clinic readiness, remains on schedule for Q3 2026. Ox-1 is being developed for the treatment of substance use disorders, a large and growing global market projected to exceed US$70 billion1 by 2035, where there remains a significant unme...