OncoZenge is developing BupiZenge as a locally acting, long-lasting, non-opioid lozenge intended to relieve severe oral pain in oral mucositis. The condition is a side effect of radiotherapy and chemotherapy that can cause ulcers, swallowing difficulties, infection risk and weight loss. In severe cases, mucositis can lead to treatment breaks, making symptom management clinically relevant beyond comfort alone.
Despite its impact, mucositis pain is often treated as a secondary issue in routine care. Management may rely on short-acting topical lidocaine products, over-the-counter analgesics and other supportive measures, and some patients ultimately require opioids.
A broader focus on opioid-sparing pain management has increased attention on alternatives that can provide meaningful relief without dependence risks. In supportive cancer care, that leaves a clear need for more reliable options for mucositis-related oral pain.
Repurposing a trusted anaesthetic
BupiZenge is based on bupivacaine, a well-established local anaesthetic used in clinical practice for decades. The concept is to translate known pharmacology into a lozenge designed for the oral cavity, aiming to provide sustained analgesia directly at the mucosal injury site.
Because mucositis pain is local and persistent, a long-acting, locally delivered approach may address gaps left by today’s toolbox, which often relies on short-acting topical products, systemic analgesics or escalation to opioids.
Progress in 2025: funding and preparations
In 2025, OncoZenge has shifted from planning to execution. The company has stated that financing for the European phase III programme has been secured through investments from Yangtian Bio-Pharmaceutical, convertible financing from Linc AB and accelerated milestone inflows from Molteni Farmaceutici, totalling approximately SEK 46,7 million.
In early December 2025, OncoZenge announced an amended agreement with Molteni under which Molteni will formally assume responsibility for commercial-scale, high-volume manufacturing of BupiZenge for Europe. The revision does not change existing responsibilities or commercial terms, including milestones, but allows OncoZenge to avoid building its own manufacturing organisation and to shift much of the supply-chain execution – including procurement, production and quality responsibilities – to its partner.
Molteni is also expected to handle launch, marketing and distribution in Europe, while scaling up manufacturing during 2026 as OncoZenge focuses on phase III execution. The European supply chain could also be used by future licensees in other regions if relevant.
Operationally, OncoZenge has engaged LINK Medical to support the clinical programme and reported interest from sites across Scandinavia and Germany. In parallel, manufacturing preparations have progressed with Meribel Pharma Solutions. The company’s communicated timeline is to submit the clinical trial application before year-end, with first patient planned for Q2026 XNUMX.
UCLA study adds patient input
Adding to the 2025 development story is a patient engagement study at the University of California, Los Angeles (UCLA), where the first patient has recently been enrolled. The study aims to gather self-reported insights from up to 45 patients, alongside clinician input, on how oral mucositis is experienced and managed today.
This exploratory UCLA-led study is not designed to measure treatment effect. Instead, the objective is to translate patient feedback into a more workable phase III setup that reduces drop-out risk. The initiative also marks the company’s first activity in the US and may support longer-term regulatory planning alongside the Europe-focused programme.
Strengthening the advisory board
As the project moves toward phase III, OncoZenge has continued to build its advisory board. Dr. Mogensen’s appointment adds the co-inventor perspective behind bupivacaine-based lozenges, alongside experience in anaesthesiology and pain management.
He joins a group of experts in oncology and supportive care. The board includes Professor Stephen T. Sonis of Harvard University, an expert on tissue toxicities of cancer therapy; Dr. Pooja Nandwani Patel, Head of Radiation Oncology at Sterling Cancer Hospital in India; and Dr. Paolo Bossi, Head of the Head and Neck Cancer Unit at Humanitas University in Milan, who also chairs MASCC’s Mucositis Study Group, which works on evidence-based clinical practice guidelines in mucositis. Collectively, the board covers expertise ranging from translational research and regulatory work to quality-of-life research and clinical supportive care.
Comments from Dr. Torben Mogensen
As co-inventor, what do you see as the most compelling rationale for BupiZenge in oral mucositis pain, and what would define success in a phase III setting?
- I expect the study will reproduce the positive findings from the phase II study.
From your clinical perspective, how is oral mucositis pain typically managed today, and where do you see the most consequential gaps in current practice?
- Today, the great variation in treatments illustrates the poor results. There are treatments involving both opioids and lidocaine (a short-acting local anesthetic), but they are not effective enough.
Oral mucositis is sometimes described as a neglected complication compared with other side effects of cancer treatment. Do you agree, and what do you think has historically held back better solutions?
- No, I know that everyone involved in the treatment of mucositis takes it very seriously. However, as I mentioned, it has not been possible to find an effective treatment previously.
Beyond pain itself, what do you consider the most important downstream consequences of mucositis for patients – such as nutrition, weight loss and sleep – and how might better pain control influence treatment adherence?
- I have no doubt about this. Effective pain treatment will increase the quality of life enormously. Furthermore, we know that some patients are forced to stop treatment due to poor physical status caused by nutritional problems. Good pain treatment will therefore increase treatment adherence.
How do you assess the magnitude of the unmet need, and what does that imply for the healthcare impact of improved pain control in oral mucositis?
- I think there is a great need for effective treatment. We are seeing an increase in head and neck cancer due to HPV infection. With better pain control, I believe we will see fewer patients with complications due to mucositis, and thereby a reduced load on the healthcare system.
What do you see as the most important points of differentiation for a locally acting, long-lasting bupivacaine lozenge compared with current strategies, including lidocaine-based products, NSAIDs and opioids?
- You see a longer-lasting effect on pain with bupivacaine compared to lidocaine. A lozenge also provides better distribution in the mouth compared to a fluid; I think this is also an explanation for the results in our previous studies. Opioids have many side effects, like nausea and constipation—side effects that cause patients great problems. Furthermore, opioids are not very effective for treating mucositis pain specifically.
In the upcoming phase III program, OncoZenge plans to track opioid use and patient weight as indicators linked to quality of life. Why do these measures matter from a clinical adoption perspective?
- It is not easy to measure pain and the effect of pain treatment in an objective way. Today we use scales like the visual analogue scale (VAS). However, it is easy to measure the use of opioids. The purpose of pain relief is to increase the quality of life and the patient's ability to complete the treatment. Weight is a good parameter for both.
The UCLA study is designed to capture patient-reported insights that can refine the European phase III setup. Which aspects of patient feedback do you believe are most valuable to incorporate in the study design?
– Insights regarding the patient's adherence to the treatment.
Looking ahead to real-world implementation, what practical factors will determine whether a new supportive-care option becomes widely used in hospitals?
- I think the most important parameter is the clinical effect of the treatment. Also, how easy the new treatment is for staff and patients to use is important. I think price plays a minor role because we simply do not have an effective treatment for mucositis pain today.
Finally, why did you choose to join OncoZenge's advisory board now, and where do you believe your experience can contribute most as the company moves into phase III?
- Since the initial development of the lozenge, I and my co-inventors have worked for it to benefit patients. I have been a member of the OncoZenge board previously, but for various reasons, I needed to take a break. I am very happy to be back on the advisory board.
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