Dublin, Ireland, August 20, 2026
Keenova Therapeutics plc has announced that the first patient has been enrolled and dosed in its Phase 3 clinical trial evaluating XIAFLEX® (collagenase clostridium histolyticum) as a potential nonsurgical treatment for hammer toe. The milestone marks a significant step in the development of a new therapeutic approach for a common foot deformity for which there are currently no FDA-approved nonsurgical therapies specifically indicated for hammer toe. The randomized clinical program is designed to evaluate the efficacy, safety and tolerability of XIAFLEX in adults with the condition.
Phase 3 Trial Evaluates XIAFLEX for Hammer Toe
The Phase 3 study, designated KN3835-313, is a double-blind, randomized, placebo-controlled clinical trial expected to enroll approximately 550 participants across 35 sites in the United States. The primary endpoint will assess whether treatment with XIAFLEX can improve the ability to straighten the affected toe by reducing flexion contracture of the proximal interphalangeal (PIP) joint. Researchers will also evaluate secondary measures involving foot function, activity limitations and participants’ assessments of overall hammer toe severity. The first-patient dosing milestone moves the program into a pivotal development stage and provides an opportunity to generate clinical evidence for XIAFLEX in this previously unapproved indication. The study is registered on ClinicalTrials.gov under NCT07759362.
Investigational Nonsurgical Option Addresses Unmet Need
Hammer toe is a musculoskeletal deformity in which one or more toes, commonly the second toe, bend downward at the middle joint because of flexion or contracture of the PIP joint. The condition can cause pain, discomfort and difficulty walking and may affect mobility and quality of life. Current management generally ranges from conservative measures such as footwear modification, orthotics, exercises and physical therapy to surgical correction in more advanced cases. Keenova is evaluating XIAFLEX as a potential nonsurgical treatment option that could address the underlying contracture. The company noted that claims data analysis indicated approximately 2 million U.S. adults were diagnosed with hammer toe in 2025, highlighting the potential patient population for additional treatment approaches. The company describes the Phase 3 program as the first registered randomized Phase 3 trial evaluating XIAFLEX specifically for hammer toe.
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XIAFLEX Advances Into Pivotal Clinical Development
XIAFLEX is already approved by the U.S. Food and Drug Administration for certain urological and orthopedic conditions, but its use for hammer toe remains investigational and has not been FDA approved for this indication. The Phase 3 trial therefore represents an important development milestone as Keenova evaluates whether the established collagenase therapy can be applied to another musculoskeletal condition. If successful, the program could provide additional evidence for a treatment strategy aimed at reducing toe contracture without surgery. However, the efficacy, safety and tolerability of XIAFLEX for hammer toe have yet to be established, and the outcome of the Phase 3 study will be important in determining the future regulatory pathway for this indication. Keenova Therapeutics, headquartered in Dublin, Ireland, develops branded therapies across specialty areas including orthopedics, rheumatology, ophthalmology, nephrology, neurology, pulmonology and urology.
Source: Keenova Therapeutics press relese
