Swedish pharmaceutical company OncoZenge AB (Nasdaq First North Growth Market:ONCOZ) announced on Tuesday that it has received European regulatory approval to initiate its pivotal Phase III BEAM-Pain trial of BupiZenge (BZ003) for oral pain in cancer supportive care.

The approval follows a Clinical Trial Application submitted in December 2025, with Denmark acting as Reference Member State and Sweden, Norway and Germany as Concerned Member States.

The randomised, multi-centre study will evaluate BupiZenge versus lidocaine in 150 patients suffering from oral pain due to radiotherapy-induced mucositis in head and neck cancer, with enrolment planned across up to 12 sites in Norway, Sweden, Denmark and Germany. The company expects to enrol the first patient in Q2 2026.

This approval triggers milestone payments, including SEK15.1m from Sichuan Yangtian Bio-Pharmaceutical Co Ltd and an accelerated EUR550,000 payment from Molteni Farmaceutici S.p.A., strengthening OncoZenge's financial position ahead of trial execution.