After thriving on the market for more than a decade as the only treatment for Dupuytrens contracture and Peyronie’s disease, Keenova Therapeutics’ Xiaflex has excelled in a phase 3 trial that could set up the injectable biologic enzyme for approval in a third indication.
The study of 436 patients with plantar fibromatosis achieved its primary endpoint, showing statistically significant and clinically meaningful reductions in pain versus placebo as measured by the Average Daily Pain Intensity on the Numeric Rating Scale (NRS).
Patients received two injections, separated by a span of at least 28 days, and recorded foot pain intensity on a scale of 0-10, with a 2-point difference considered clinically meaningful. Keenova did not reveal figures related to the scoring.
The study also aced its secondary endpoints as measured by the Foot Function Index (FFI) scale, a 23-item questionnaire which asks patients to rate their levels of pain, disability and activity limitation, also on a 0-10 basis.
The safety profile of Xiaflex in the trial was consistent with its established indications. Most adverse events were rated by investigators as mild to moderate and there were no treatment-related serious adverse events, according to the company.
Keenova chief scientific officer Marek Honczarenko, M.D., said that the company plans to submit for FDA approval in the fourth quarter of this year with hopes to launch Xiaflex in the indication in 2028.
Plantar fibromatosis, which is also known as Ledderhose disease, causes lumps composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. It can cause pain, swelling, and difficulty walking. Based on claims data and projections, Keenova estimates that 300,000 people will see a healthcare provider for plantar fibromatosis in 2028.
There is no medicine on the market specifically for plantar fibromatosis. Patients can get relief through radiation therapy or corticosteroid injections, with surgical interventions generally reserved as a last resort.
Xiaflex works by breaking down collagen, allowing thickened cords in the hands (Dupuytrens contracture) and penis (Peyronie’s disease), to dissolve and soften. FDA approvals in those indications came in 2010 and 2013.
Sales of Xiaflex have scaled up each year since it reached the market, coming to $546 million last year and $134 million in the first quarter of 2026, for an 11% year-over-year gain.
Xiaflex was developed by Auxillium Pharmaceuticals, a Pennsylvania-based biotech which was bought out in 2014 by Endo for $2.6 billion. Last year, Ireland-based generics giants Endo and Mallinckrodt merged in a $6.7 billion deal. Eight months ago, the companies spun off their generics business as Par Health and rebranded as Keenova.
In the first quarter of this year, Keenova reported revenue of $468 million, with $170 million coming from Acthar Gel, a treatment for an array of inflammatory and autoimmune conditions which has seen a recent spike in sales thanks to a new self-injection delivery device.