Collagenase clostridium histolyticum is under clinical development by Endo International and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Collagenase clostridium histolyticum’s likelihood of approval (LoA) and phase transition for Benign Tumor took place on 16 Aug 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Collagenase clostridium histolyticum Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Collagenase clostridium histolyticum overview

Collagenase Clostridium histolyticum (Xiapex, Xiaflex) contains purified collagenase Clostridium histolyticum, consisting of two microbial collagenases namely collagenase AUX-I and collagenase AUX-II. It is formulated as lyophilized powder for solution, injection for intralesional route of administration. Xiaflex is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord,  for the treatment of adult men with Peyronie’s  disease with a palpable  plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiapex also indicated for the treatment of two Dupuytren's contracture (DC) cords concurrently.

Collagenase Clostridium histolyticum is under development for the treatment of Dupuytren's contracture, uterine fibroids, human lipoma lateral thigh fat and plantar fibromatosis. The drug candidate is administered through subcutaneous route. It acts by targeting collagen.

The drug candidate was under development for the treatment of frozen shoulder syndrome.

Endo International overview

Endo International (Endo) is a specialty healthcare company that develops, manufactures and commercializes various branded pharmaceuticals, generic pharmaceuticals, sterile injectables and other products through its operating companies. It sells generic products in the US in various categories including urology, pain management, central nervous system (CNS) disorders, immunosuppression, cancer, cardiovascular diseases and women’s health. The company offers branded pharmaceuticals for conditions related to urology, orthopedics, endocrine disorders and pain management. Endo also provides over-the-counter (OTC) products, which include dermatological products and anti-infectives. The company sells its products through independent wholesale distributors to retailers, government agencies, doctors, clinics, independent retail and specialty pharmacies and independent specialty distributors. Endo is headquartered in Dublin, Ireland.

Quick View Collagenase clostridium histolyticum LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Collagenase clostridium histolyticum
Administration Pathway
  • Intralesional
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Male Health
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Non Malignant Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.