OncoZenge Submits Phase III Clinical Trial Application for BupiZenge in Cancer-Related Oral Pain
Key Insights
OncoZenge has submitted a Clinical Trial Application to the European Medicines Agency (search) for its pivotal Phase III trial (BZ003) of BupiZenge (search), a novel non-opioid oral lozenge for cancer-related oral pain.
The randomized registrational trial will evaluate BupiZenge (search)'s efficacy and safety compared to lidocaine in 150 head and neck cancer (search) patients experiencing oral mucositis (search) from radiotherapy with or without chemotherapy.
Patient recruitment is expected to commence in Q2 2026 across multiple sites in Norway, Sweden, Denmark and Germany, following regulatory approval.
OncoZenge AB (search), a clinical-stage pharmaceutical company developing innovative treatments for oral pain in cancer supportive care, has submitted a Clinical Trial Application (CTA) for its pivotal Phase III trial (BZ003) of BupiZenge (search)™ to the European Medicines Agency (search) (EMA). This milestone represents a significant advancement in the company's efforts to address the unmet medical need for effective oral pain management in cancer patients.
Phase III Trial Design and Scope
The BupiZenge (search)™ Phase III trial (BZ003) is designed as a multi-center, randomized registrational trial to evaluate the efficacy and safety of BupiZenge™ compared to lidocaine in patients experiencing pain due to oral mucositis (search) induced by radiotherapy with or without concomitant chemotherapy in head and neck cancer (search) patients. The study will recruit 150 patients and be conducted across multiple sites in Norway, Sweden, Denmark and Germany.
Patient recruitment is expected to commence in Q2 2026, following regulatory approval from the relevant authorities.
Novel Treatment Approach
BupiZenge (search)™ is a novel, non-opioid oral lozenge formulation of the well-established local anesthetic bupivacaine. The treatment represents a potential breakthrough for cancer patients who currently have limited effective treatment options for debilitating oral pain associated with cancer therapy.
In a previously completed Phase II study, BupiZenge (search)™ demonstrated statistically significant and clinically meaningful pain relief compared to standard of care, together with a favorable safety profile.
Clinical Significance and Expert Perspectives
According to Marie-Louise Fjällskog, MD, oncologist and clinical development advisor, "Cancer patients undergoing radiation or chemotherapy often experience severe oral mucositis (search) despite today's standard of care. BupiZenge (search)™ has the potential to meaningfully improve their quality of life—helping them eat and drink more comfortably, reducing reliance on opioids, and supporting completion of their treatment regimens."
Stian Kildal, Chief Executive Officer of OncoZenge, commented: "The submission of our clinical trial application marks a major milestone in OncoZenge's history, and it brings us significantly closer to delivering BupiZenge (search)™ to the millions of cancer patients who suffer from debilitating oral pain with limited effective treatment options today."
Regulatory and Development Progress
Christina Junvik, Head of Regulatory, noted that the CTA submission represents the culmination of extensive preparation: "We have worked closely with sites, patients, and external advisors to ensure the Phase III trial is both practical to conduct and aligned with regulatory expectations. We now look forward to interactions with the authorities in the New Year, and continuing the steps needed to eventually offer BupiZenge (search)™ to patients."
The company has also strengthened its financial position through a directed share issue to Sichuan Yangtian Biological Pharmaceutical (search), pursuant to an investment agreement, which supports the continued execution of the Phase III program.
Strategic Partnerships and Manufacturing Readiness
OncoZenge has collaborated with LINK Medical (search) as its Contract Research Organization (CRO) for site identification, preparation of clinical documentation, and CTA submission. The company has also worked with Meribel Pharma Solutions, Galenica and Molteni Farmaceutici to ensure manufacturing readiness for both trial and potential commercial use.
Tuulikki Lindmark, Head of CMC, emphasized the importance of this milestone: "This milestone is a critical step forward in BupiZenge (search)'s product development, where our Phase III product and process need to demonstrate readiness for trial, and commercial use, upon future regulatory approval."