Dublin, Ireland, August 3, 2026
Keenova Therapeutics plc announced the publication of a new manuscript evaluating XIAFLEX® (collagenase clostridium histolyticum) treatment outcomes in men with Peyronie’s disease, with a specific focus on whether baseline penile pain influences therapeutic outcomes. The Keenova-sponsored post hoc analysis of existing XIAFLEX clinical trial data was published in Translational Andrology and Urology and examined information from the pivotal IMPRESS I/II studies. The research adds to the clinical evidence surrounding XIAFLEX and provides further insight into the relationship between pain, disease characteristics and treatment decision-making for men affected by Peyronie’s disease.
IMPRESS Analysis Examines Pain and XIAFLEX Treatment Outcomes
The manuscript, titled “Peyronie’s Disease Patients With Pain: A Post Hoc Analysis of the IMPRESS I/II Studies,” evaluates whether the presence of penile pain at baseline should influence expectations surrounding treatment outcomes with XIAFLEX. According to Keenova, the findings highlight the importance of looking beyond pain alone when evaluating patients with Peyronie’s disease. Investigators indicated that pain and disease duration are important clinical factors but should not be used as the sole determinants of treatment timing. Instead, treatment decisions should incorporate a broader clinical assessment and the evolving scientific understanding of Peyronie’s disease. The analysis is particularly relevant because penile pain may be considered when assessing disease stage and determining when therapeutic intervention should occur. By re-examining existing IMPRESS I/II clinical data, the study provides additional information that may help clinicians understand the role of baseline pain when evaluating patients for treatment with collagenase clostridium histolyticum.
XIAFLEX Targets Fibrous Plaque in Peyronie’s Disease
Peyronie’s disease is characterized by the development of fibrous scar tissue that causes abnormal penile curvature, which can interfere with arousal and intimacy and substantially affect quality of life. Keenova noted that the condition may affect as many as one in 10 men in the United States, although diagnosis rates remain low because some patients may be uncomfortable discussing their symptoms or seeking medical care. XIAFLEX is indicated for adult men with Peyronie’s disease who have a palpable plaque and curvature deformity of at least 30 degrees at the beginning of therapy. The therapy contains collagenase clostridium histolyticum and is administered directly into the Peyronie’s plaque. Treatment requires careful clinical management because injection into collagen-containing structures outside the targeted plaque can cause serious injury. The product carries a boxed warning regarding corporal rupture, also known as penile fracture, and other serious penile injuries. Because of these risks, XIAFLEX for Peyronie’s disease is available only through the restricted XIAFLEX Risk Evaluation and Mitigation Strategy (REMS) Program.
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Publication Adds to Clinical Evidence Supporting XIAFLEX
The newly published analysis extends the clinical evidence generated from the IMPRESS I/II studies by exploring how baseline patient characteristics may relate to outcomes following XIAFLEX treatment. The findings reinforce the importance of a comprehensive clinical assessment when determining treatment timing, rather than relying exclusively on penile pain or disease duration. Safety remains an important consideration in XIAFLEX treatment. In clinical studies, corporal rupture was reported in 5 of 1,044 XIAFLEX-treated patients, while severe penile hematoma occurred in 39 of 1,044 patients. The most frequently reported adverse drug reactions occurring in at least 25% of patients and at a higher incidence than placebo included penile hematoma, penile swelling and penile pain. Keenova Therapeutics is a U.S.-focused branded therapeutics company developing and commercializing treatments across specialty areas with significant unmet medical needs, including urology, rheumatology, ophthalmology, nephrology, neurology, pulmonology, orthopedics and neonatal respiratory critical care. The publication of the XIAFLEX Peyronie’s disease post hoc analysis provides clinicians with additional evidence to consider when assessing treatment candidates and underscores the continuing role of clinical data analysis in refining patient management strategies for this potentially underdiagnosed condition.
Source: Keenova Therapeutics press release
