Red Leaf Medical and Bionorica Announce Strategic Partnership to Launch Canephron in Canada, Offering a Breakthrough First-Line, Non-Antibiotic UTI Treatment.
Mississauga, Ontario, Canada and Neumarkt, Germany — September 5, 2025 —
Red Leaf Medical Inc., a leading Canadian healthcare company specializing in the field of urology, and Bionorica SE, one of the world’s foremost producers of scientifically researched phytopharmaceuticals, today announced their exclusive partnership to bring Canephron to the Canadian market. This innovative herbal medicine is a unique first-line, non-antibiotic treatment for acute uncomplicated urinary tract infections (UTIs), and holds the potential to significantly reduce antibiotic use and combat the rising threat of antimicrobial resistance (AMR).
Currently marketed in over 41 countries, Canephron has earned global recognition as a clinically proven, first-line, non-antibiotic treatment for UTIs. With over two decades of growing sales and success, Canephron is the market leader in OTC market for UTI in Germany and has gained market share from antibiotics in countries like, Austria, Switzerland and Greece.
A Novel Mechanism of Action with Proven Results
Canephron’s unique formulation provides anti-inflammatory, anti-adhesive, analgetic and spasmolytic properties. This multi-target mechanism not only alleviates UTI symptoms such as dysuria, urgency, and frequency, but also helps normalize the host’s immune response by reducing inflammatory markers like IL-6 and IL-8, comparable to standard antibiotic therapy1.
In a landmark Phase III randomized controlled trial2, Canephron demonstrated non-inferiority to fosfomycin, a first-line antibiotic, in managing acute UTIs. 83.5% of patients treated with Canephron did not require additional antibiotics, underscoring its potential as an effective first-line option. In a retrospective cohort study based on data from the IMS® Disease Analyzer database (IQVIA)3 in Germany, real-world evidence confirmed fewer recurrent UTIs, lower rates of additional antibiotic prescriptions, and reduced sick leave days among Canephron users versus those treated with antibiotics.
A Public Health Opportunity to Combat AMR
With urinary tract infections affecting nearly half of all women at least once in their lives and growing resistance to commonly used antibiotics, the introduction of Canephron in Canada marks a vital step toward improving patient care and advancing antimicrobial stewardship.
“We are excited to partner with Bionorica to launch Canephron in Canada,” said Charles Ko, CEO of Red Leaf Medical. “This product addresses a critical clinical need with an evidence-backed, non-antibiotic solution. Its ability to deliver clinical efficacy while reducing reliance on antibiotics makes it a timely and powerful addition to our portfolio.”
Red Leaf Medical intends to file a Product License Application to Health Canada in Q4 of 2025. Once approved, Canephron will be available to purchase without a prescription .
About Canephron
Canephron (BNO 1045) is a well-established phytopharmaceutical approved in 41 countries for the treatment and prevention of urinary tract conditions. Its clinically validated herbal formulation has demonstrated non-inferior efficacy to an antibiotic(fosfomycin) for the treatment of acute UTIs, symptom relief, microbiota preservation, and reduction in recurrence of UTIs.
About Bionorica SE
Bionorica SE is a global leader in evidence-based herbal medicine, headquartered in Neumarkt, Germany. The company integrates modern pharmaceutical research with traditional botanical knowledge to produce clinically effective, plant-based therapies.
About Red Leaf Medical Inc.
Red Leaf Medical is a Canadian healthcare company committed to delivering innovative, best-in-class therapies and services in urology. With a strong track record of commercializing novel products, Red Leaf Medical is trusted by urologists and urology nurses across the country.
Media Contact:
Red Leaf Medical Inc.
info@redleafmedical.com
+1 (905) 569-7771
Bionorica SE
info@bionorica.de
- Butler, et. al., BNO 1045 Therapy Limits Local Inflammatory Responses, Urol Int 2023
- Wagenlehner, et. al., BNO 1045 Herbal Therapy vs. ABs for uUTI: A Phase III Clinical Trial, Urol Int 2018
- Höller et. al., Treatment of Urinary Tract Infections with Canephron® in Germany: A Retrospective Database Analysis. Antibiotics 2021.
[i] Council of Canadian Academies, 2019. When Antibiotics Fail. Ottawa (ON): The Expert Panel on the Potential Socio-Economic Impacts of Antimicrobial Resistance in Canada, Council of Canadian Academies.
[ii] Foxman B, Barlow R, D’Arcy H, et al. Self-reported incidence of urinary tract infection and associated costs. Ann Epidemiol 2000;10:509-15. https://doi.org/10.1016/S1047-2797(00)00072-7.
[iii] Epp A, Larochelle. ASOGC clinical guidelines for rUTI. J Obstet Gynaecol Can 2017;39:e422-31. https://doi.org/10.1016/j.jogc.2017.08.017
[iv] Nicolle, L. (2013). Urinary Tract Infection. In J. F. M. Nunez, J. S. Cameron & D. G. Oreopoulos (Eds.), The Aging Kidney in Health and Disease. London, United Kingdom: Spring Science+Business Media.
[v] Wagenlehner F, Wullt B, Ballarini S et al: Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res 2018; 18: 107-117.
[vi] Nickel JC, Lee JC, Grantmyre JE, Polygenis D. Natural history of urinary tract infection in a primary care environment in Canada. Can J Urol 12:2728-2737, 2005.
[vii] Renard J, Ballarini S, Mascarenhas T et al. Recurrent lower urinary tract infections have a detrimental effect on patient quality of life: a prospective, observational study. Infect Dis Ther 2015; 4: 125-135.
[i] Anger J, Lee U, Ackerman AL. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol 2019;202:282-289.
