Regulatory Green Light for trial 0205, the pivotal trial for CT001 – first patient expected shortly

Cessatech A/S announces that the pivotal trial 0205 has obtained regulatory approval and thereby… Cessatech A/S announces that the pivotal trial 0205 has obtained regulatory approval and thereby green light by the authorities and is now ready to initiate patient recruitment. The trial will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised, double-blind placebo controlled trial with 220 patients. Comment from Jes Trygved, CEO of Cessatech We are very pleased with finally being able to initiate this important trial, and the company is now moving into a different stage with its pivotal study – great work and effort by all the people involved in the preparation of this trial. Unfortunately, it has taken much too long a time and we are disappointed that the approval process, in particular with the Ethical Committee, is so cumbersome and not in favour of an innovative company and industry. CT001 is getting closer to the market and its potential patients and the period ahead will be extremely interesting. See full press release 220630 – Regulatory green light trial0205 Related articles Releases 27. August, 2026 CT001 ready for shipment to initial U.S. hospitals as launch activities commence Initial U.S. commercial supply of CT001 now available for shipment Launch activities initiated with... Read more Releases 24. July, 2026 Proveca intends to request a re-examination of CHMP opinion for CT001/KemSu See also the updated Q&A documentation related to the Release: Link The European Medicines... Read more Releases 12. June, 2026 Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet Cessatech enters collaboration with University Hospital of Copenhagen, Rigshospitalet, to advance an intravenous formulation of melatonin for post-anaesthesia delirium (CT004) in children ... Read more Stay up to date! Subscribe and get notified on Cessatech's latest news. An acceptance email will be sent to you, please check your spam. Please leave this field empty Almost there! Please check your inbox to confirm your subscription to Cessatech.

The release as fetched from its publisher. cessatech.com ↗