OncoZenge AB has selected LINK Medical, a Nordic-based clinical research organization (CRO), to lead the Phase III trial for BupiZenge, its innovative drug candidate designed to relieve oral pain from mucositis in cancer patients.
The program will enroll approximately 150 patients across 10-12 sites in Norway, Sweden, Denmark, and Germany. Patient recruitment and study results are expected in 2026, with the primary focus on reducing patients' pain compared to lidocaine. Secondary endpoints will include quality-of-life measures (e.g., eating ability, sleep), weight as a proxy for oral intake, and opioid consumption. Pain remains the leading cause for deferred or terminated cancer therapy, affecting cancer patient outcomes, a testament to the inadequacy of today's standard of care.
BupiZenge is a novel oral lozenge developed to provide effective, fast, and long-lasting pain relief in patients with oral mucositis. It has shown superior results in previous clinical studies and is expected to offer an improved, opioid-sparing treatment option for patients suffering from this debilitating condition.
"We are very pleased to award the BupiZenge Phase III clinical project execution to LINK Medical," said Stian Kildal, CEO of OncoZenge AB. "After a successful Phase III feasibility study in Europe we have full confidence in LINK Medical's experience and expertise to successfully conduct our Phase III study. Their strong presence in Northern Europe, leadership commitment and experience in oncology trials make them a very suitable partner. We look forward to take the next steps in contracting sites and finalizing the necessary documentation for the regulatory dossier for our Clinical Trial Application."
"Oncology and pain management are key focus areas for LINK Medical, a passion we share with the team at OncoZenge and our network of experienced sites across Northern Europe" said Anders Göransson, CEO of LINK Medical. "We are proud to leverage this dedication to help advance the BupiZenge clinical program and bring hope to patients affected by oral mucositis worldwide."
About LINK Medical?
LINK Medical is a full-service clinical research organization (CRO) operating in Northern Europe. LINK Medical's reach supports clinical trials across multiple countries and specializes in the planning and execution of pivotal registration clinical trials. With offices in six countries and a team of 160 dedicated professionals, LINK Medical is committed to delivering high-quality services as measured by its employees, customers, investigators, and vendors. www.linkmedical.eu.
About BupiZenge?
BupiZenge has been developed by OncoZenge and is a novel oral lozenge formulation of the local anesthetic bupivacaine, with decades of documented therapeutic use. BupiZenge has been successfully evaluated in Phase I and Phase II studies. BupiZenge is being developed for the treatment of oral pain caused by oral mucositis, an inflammatory condition affecting cancer patients. BupiZenge has the potential to provide substantially better pain relief compared to the current standard of care, enabling patients to eat and drink more comfortably while reducing reliance on opioids.
About Oral Mucositis?
Oral mucositis is an inflammatory condition of the oral mucosa, often resulting from chemotherapy and radiotherapy in cancer treatment. It affects millions of cancer patients annually, causing severe pain, ulcers, and difficulty in eating, drinking, and speaking, which can lead to malnutrition, infections, and treatment interruptions. Approximately 18 million people are diagnosed with cancer each year globally, with oral mucositis estimated to occur in at least 35% of all patients, and nearly 100% of those affected by head and neck cancers. Today patients often rely on inadequate symptom management and opioids, highlighting a clear unmet need for better options like BupiZenge. The market potential for effective treatments is estimated at $1 billion globally, annually.
BupiZenge - Potential to be the leading treatment for oral pain.
For additional information, please contact:
Stian Kildal, CEO, mobile: +46 76 115 3797, e-mail: stian.kildal@oncozenge.se
About this release
The information in this release was submitted for publication, through the agency of the contact person(s) set out above, at 17:10 CEST on September 10, 2025.
Certified Adviser
OncoZenge's Certified Adviser is Redeye AB.
OncoZenge AB
Gustavslundsvägen 34, 167 51 Stockholm, Sweden
About OncoZenge AB
OncoZenge AB (publ) is a clinical-stage pharmaceutical company developing an innovative, effective, and well-tolerated treatment for oral pain in conditions where current options are insufficient, such as oral mucositis from cancer therapy. Its lead candidate, BupiZenge, represents a novel formulation of bupivacaine in a lozenge form, aimed at providing rapid and sustained local pain relief without the risks associated with systemic opioids. OncoZenge is headquartered in Stockholm, Sweden, and is publicly traded on Nasdaq First North Growth Market under the ticker ONCOZ. For more information, please visit www.oncozenge.se.
