Xiaflex (collagenase clostridium histolyticum) / Asahi Kasei Therapeutics, SOBI, Endo - LARVOL DELTA

Cellulite: What is it, why is it & how is it prevented and treated? (EADV 2026) - "Research has shown that it's superior to placebo but further evaluation of collagenase clostridium histolyticum for cellulite should be performed...Collagen stimulators are being used for cutaneous laxity, and they can be used in combination with different technologies. Although research in the field yielded efficacious treatment modalities for cellulite, as a multifactorial condition, no single treatment seems to entirely solve this condition."

Aesthetic Medicine • CNS Disorders • Depression

Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT) (clinicaltrials.gov) - P3 | N=554 | Recruiting | Sponsor: Endo USA Inc., a Keenova Therapeutics Company | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Diseases • Orthopedics

The impact of collagenase clostridium histolyticum (CCH) priming on surgical outcomes in Peyronie's disease: a retrospective cohort study. (PubMed, Transl Androl Urol) - "Prior CCH exposure was not associated with statistically significant differences in curvature correction or complication rates following tunica albuginea plication, and revision surgery rates were also not statistically different between groups. Larger studies are warranted to improve statistical power to better evaluate potential differences in revision rates and other surgical outcomes."

Journal • Retrospective data • Pain • Rheumatology • Sexual Disorders

Efficacy and safety of hyaluronic acid and enzymatic mix intralesional therapy in Peyronie's disease: a prospective, randomized, controlled pilot study of outcomes and patient satisfaction. (PubMed, J Sex Med) - P=N/A | "Fibrorestil intralesional therapy demonstrates possible improvements in curvature and patient-reported outcomes versus conservative care in stable-phase PD and appears safe, while conservative care alone showed no meaningful improvement. Given baseline imbalances, small pilot sample size, open-label design, and lack of an equivalent sham injection control, these findings should be considered exploratory and require confirmation in larger randomized trials."

Clinical • Journal • Diabetes • Fibrosis • Metabolic Disorders

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease (clinicaltrials.gov) - P4 | N=40 | Active, not recruiting | Sponsor: Charitable Union for the Research and Education of Peyronie's Disease | Recruiting ➔ Active, not recruiting

Enrollment closed

Efficacy of a Novel CCH Protocol for PD Among Prior Non-responders (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: Charitable Union for the Research and Education of Peyronie's Disease | Active, not recruiting ➔ Completed | Trial completion date: Sep 2028 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion • Trial completion date • Trial primary completion date

The Impact of Emerging Therapies and Declining Physician Reimbursement on Dupuytren Disease Treatment: A 21 Year Review. (PubMed, J Hand Surg Glob Online) - "This study aimed to evaluate the trends in treatment and physician reimbursement for Dupuytren contracture (DC) within the Medicare population over a 21-year period, with a focus on how the introduction of collagenase Clostridium histolyticum (CCH) has affected treatment patterns...Treatment patterns for DC have evolved alongside the introduction of less invasive therapies and increasing public awareness. Understanding how utilization, reimbursement, and public interest intersect is essential for informed, evidence-based decision making in the management of DC."

Journal • Reimbursement • US reimbursement

Bridging fibrosis and function: an integrated mechanistic and therapeutic framework for Peyronie's disease and related erectile dysfunction. (PubMed, Sex Med) - "Therapeutic strategies increasingly adopt multimodal approaches: phosphodiesterase-5 inhibitors improve hemodynamics and may attenuate early fibrotic activity; intralesional therapy remains central to nonsurgical management, with collagenase Clostridium histolyticum as the established standard for plaque remodeling and adjunct injectables such as verapamil, interferon-α2b, and hyaluronic acid providing additional anti-inflammatory or antifibrotic benefits, particularly in the active phase; and low-intensity shockwave therapy promotes angiogenesis and tissue recovery...PD and ED represent a shared vascular-fibrotic spectrum requiring integrated, mechanism-driven management. Emerging regenerative and molecular therapies, supported by artificial intelligence-assisted diagnostics and digital health tools, signal a paradigm shift toward personalized, holistic restoration of structure, function, and intimacy."

Journal • Review • Erectile Dysfunction • Fibrosis • Immunology • Sexual Disorders • TGFB1

Peyronie's disease patients with pain: a post hoc analysis of the IMPRESS I/II studies. (PubMed, Transl Androl Urol) - P3 | "To determine whether penile pain should inform PD treatment timing, we analyzed the association between baseline penile pain levels and treatment efficacy using data from the IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I/II studies of collagenase clostridium histolyticum (CCH)...Men with PD who were treated with CCH experienced similar curvature improvements regardless of baseline pain status or disease duration among those who experienced any pain. Findings support the literature that demonstrate similar efficacy when treating men with active vs. stable disease, suggesting that ongoing pain is not a contraindication to CCH therapy."

Journal • Retrospective data • Pain

Study to Assess KN3835 in the Treatment of Flexible/Semi-Flexible Hammertoe (HMT) (clinicaltrials.gov) - P3 | N=554 | Not yet recruiting | Sponsor: Endo USA Inc., a Keenova Therapeutics Company

New P3 trial • Musculoskeletal Diseases • Orthopedics

Collagenase nanocapsules for the treatment of Peyronie's disease. Evaluation in fibrotic plaques obtained from human patients. (PubMed, J Sex Med) - "Extending CCH activity and efficacy by nanoencapsulation may reduce injection repeats and improve therapeutic response to CCH injection, potentially representing a therapeutic strategy. Superiority of ColNC was demonstrated with biochemical assays, cell culture procedures, and in vitro functional evidence in plaque tissue from PD patients. Main limitation was the relatively low number of human samples due to limited human tissue availability. Encapsulation of collagenase into polymeric NC extends enzymatic activity and efficiency to degrade fibrous PD plaque. These results suggest that treatment with ColNC may represent a potential therapeutic strategy to reduce injection repeats in the management of PD but requires validation in in vivo and clinical studies."

Journal • Fibrosis • Immunology

STRIDE: Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease) (clinicaltrials.gov) - P3 | N=436 | Completed | Sponsor: Endo USA Inc., a Keenova Therapeutics Company | Active, not recruiting ➔ Completed

Trial completion • Fibrosis • Solid Tumor

Collagenase Injection for Contracture Management (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: The University of Texas Health Science Center, Houston

New P1 trial • Movement Disorders

Collagenase Injection for Spasticity Management (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: The University of Texas Health Science Center, Houston

New P1 trial • Movement Disorders

Impact of testosterone therapy and hypogonadism on treatment outcomes in Peyronie's disease: a multicenter retrospective analysis of collagenase clostridium histolyticum therapy. (PubMed, J Sex Med) - "Testosterone deficiency is associated with reduced curvature improvement following CCH therapy regardless of testosterone treatment, with eugonadal men demonstrating the greatest therapeutic benefit."

Journal • Retrospective data • Endocrine Disorders • Erectile Dysfunction • Pain • Rheumatology

STRIDE: Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease) (clinicaltrials.gov) - P3 | N=418 | Active, not recruiting | Sponsor: Endo USA Inc., a Keenova Therapeutics Company | Trial completion date: Mar 2026 ➔ Jun 2026 | Trial primary completion date: Mar 2026 ➔ Jun 2026

Trial completion date • Trial primary completion date • Fibrosis • Solid Tumor

Clinical outcomes in Peyronie's disease: impact of curvature severity and disease phase on symptom resolution and treatment response. (PubMed, J Sex Med) - No abstract available

Clinical data • Journal

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease (clinicaltrials.gov) - P4 | N=12 | Active, not recruiting | Sponsor: University of Miami | Recruiting ➔ Active, not recruiting | N=22 ➔ 12

Enrollment change • Enrollment closed • Sexual Disorders

Trends in Treatment and Reimbursement of Dupuytren Disease. (PubMed, J Hand Surg Glob Online) - "Treatment utilization and reimbursement data were extracted for current procedural terminology codes corresponding to percutaneous needle fasciotomy (PNF), open fasciotomy, collagenase Clostridium histolyticum injection (CCH) with manipulation, and fasciectomy-based procedures...Decreasing inflation-adjusted reimbursement highlights growing economic pressures on health care and providers. Economic decision and analysis IV."

Journal • Reimbursement • US reimbursement

Injectable Collagenase Clostridium Histolyticum as a Non-surgical Treatment for Uterine Fibroids: A Scoping Review. (PubMed, Reprod Sci) - "While current data support its safety and biological activity, evidence is limited to early-phase research. Larger prospective trials are needed to determine optimal dosing, long-term efficacy, durability of effect, and clinical utility as a standalone or adjunctive therapy."

Journal • Review • Gynecology • Oncology • Pain • Solid Tumor • Uterine Leiomyoma • Women's Health

Dupuytren's Disease of the Distal Interphalangeal Joint: A Systematic Review of Case Reports and Case Series. (PubMed, Medicina (Kaunas)) - "Surgical fasciectomy was performed in 11 cases and collagenase clostridium histolyticum (CCH) in 2 cases...However, the available evidence is limited to a small number of selectively published case reports and series with incomplete outcome and follow-up reporting. These observations should therefore be interpreted cautiously, and comparative effectiveness or durability estimates cannot be established."

Journal • Review

The Impact of Collagenase Clostridium Histolyticum (CCH) Priming on Surgical Outcomes in Peyronie's Disease: A Retrospective Cohort Study (AUA 2026) - "In this study, the cohort who received CCH was older and had a greater burden of comorbidities compared to those who did not. However, patients previously treated with CCH demonstrated higher rates of short-term postoperative complications and revision surgeries."

Retrospective data • Cardiovascular • CNS Disorders • Depression • Diabetes • Erectile Dysfunction • Hypertension • Metabolic Disorders • Myocardial Infarction • Sexual Disorders • Solid Tumor

Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie's Disease: A Randomized Trial – 3 Year Outcomes (AUA 2026) - "Participants were randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil (CCH) or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD (Surgery). Overall findings suggest that when compared to surgery at 36-months, CCH men were more likely to be very satisfied with therapy and have lesser subjective length loss and fewer overall adverse events."

Clinical • Surgery • CNS Disorders • Depression

Trends in Penile Fracture and Repair after Intralesional Collagenase Clostridium Histolyticum for Peyronie's Disease: An Analysis of the MarketScan Database 2014-2024 (AUA 2026) - "Penile fracture is a rare, but serious complication of CCH treatment. In our cohort of over 10,000 patients, the rate of penile fracture post-CCH was 0.8%. About half of patients with penile fractures underwent surgical repair, with no trend towards conservative management over time."

Musculoskeletal Diseases

Delayed Dose Collagenase Clostridium Histolyticum Protocol for Men with Peyronie's Disease: A Prospective Clinical Study (AUA 2026) - P4 | "Preliminary findings from the current study demonstrate median curvature improvements of 68% despite being only part-way into treatment. The data also suggest significant impacts of disease on partners of men with PD. Findings also report for the first time adverse event trade-offs that patients would be willing to make to achieve curvature correction."

Clinical