Keenova Therapeutics is hoping to step into a new market with Xiaflex (collagenase clostridium histolyticum), after the drug netted a Phase III win in rare foot disease, plantar fibromatosis.
To put Xiaflex to the test in this indication, Keenova conducted the pivotal EN3835-309, or STRIDE study (NCT06151197), in which the company pitted its drug against placebo in 436 patients with plantar fibromatosis, with eligible individuals all having at least one measurable fibrous lump caused by the condition.
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During the Phase III, double-blind, randomised, placebo-controlled trial, treatment with Xiaflex led to a statistically significant, patient-reported improvement in pain over placebo, meeting the trial’s primary endpoint.
On top of this, Xiaflex also improved measures of foot functionality – specifically focused on difficulty and activity limitation, as well as measures of disease severity, treatment satisfaction and the characteristics of fibrous nodules.
The drug was also proven safe and tolerable, with investigators ranking most adverse events (AEs) as mild-to-moderate. No patients experienced any severe AEs linked specifically to treatment with Xiaflex.
Xiaflex acts by breaking down collagen that forms nodules around the fibrous connective tissue in the foot called the plantar fascia.
Next steps for Xiaflex
With this Phase III success under its belt, Keenova plans to submit an application for Xiaflex in plantar fibromatosis in the final quarter of 2026. This would further expand the drug’s legacy in clinical care, which began in 2010 when the drug was originally greenlit by the US Food and Drug Administration (FDA) for progressive, hand-based connective tissue disorder, Dupuytren’s disease. Then, in 2013, the drug secured a second FDA approval in scar tissue-driven penis condition, Peyronie’s disease.
If Xiaflex were to get the FDA go-ahead in plantar fibromatosis, it would become the first drug to reach the market in this rare disease, as patients currently rely on a combination of symptom relief and off-label treatments. In a case study published in the Journal of Surgical Case Reports, the author describes the efficacy of collagenase injections in a paediatric patient after a one-year follow-up.
BioSpecifics Technologies originally developed Xiaflex, before licensing the asset to Auxilium Pharmaceuticals in 2004. Auxilium then secured the drug’s approval, before the comapny was acquired by Endo Pharmaceuticals in 2015. In November 2025, Endo then spun off its branded drug business to create Keenova Therapeutics.
Keenova looks to secure Xiaflex’s place on the plantar fibromatosis market as the therapy’s US patent nears expiry. According to press release dated at the time of Xiaflex’s first approval, the drug is expected to remain patent-protected through to July 2028.
Xiaflex generated net sales of $134m in Q1 2026, with FY2025 sales reaching $546.3m.
