XIAFLEX (collagenase clostridium histolyticum)
XIAFLEX is indicated for the treatment of Dupuytren’s Contracture; Peyronie’s Disease.
How XIAFLEX Works
XIAFLEX contains collagenases that hydrolyze collagen in its native triple helical conformation, resulting in the lysis of collagen deposits. When injected directly into a Dupuytren’s cord or a Peyronie’s plaque, the enzymes enzymatically disrupt the Type I and Type III collagen that primarily compose these structures. This disruption breaks down the physical cord or plaque to reduce contractures and penile curvature. The treatment specifically targets collagen deposits while generally sparing the structural integrity of arteries, nerves, and large veins.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-02-02
- Patent Cliff
- 2020
- Routes
- INJECTION
- Dosage Forms
- SOLUTION
XIAFLEX Approval History
What XIAFLEX Treats
2 indicationsXIAFLEX is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dupuytren’s Contracture
- Peyronie’s Disease
XIAFLEX Boxed Warning
CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded...
WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a combination of penile ecchymoses or hematoma, sudden penile detumescence, and/or a penile “popping” sound or sensation was reported, and in these cases, a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients [see Warnings and Precautions (5.2)] . Signs or symptoms that may reflect serious penile injury should be promptly evaluated to assess for corporal rupture or severe penile hematoma which may require surgical intervention [see Warnings and Precautions (5.2)] . Because of the risks of corporal rupture or other serious penile injury, XIAFLEX is available for the treatment of Peyronie’s disease only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XIAFLEX REMS Program [see Warnings and Precautions (5.3)] . WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE See full prescribing information for complete boxed warning Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9%), a diagnosis of corporal rupture cannot be excluded. Severe penile hematoma was also reported as an adverse reaction in 39 of 1044 (3.7%) XIAFLEX-treated patients. ( 5.2 ) XIAFLEX is available for the treatment of Peyronie’s disease only through a restricted program called the XIAFLEX REMS Program. ( 5.3 )
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03406338 | Hlm_DC | Ph 4 | active not recruiting | Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease |
| NCT06649539 | CUREPD120 | Ph 4 | recruiting | Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease |
| NCT04580303 results posted | EN3835-224 | Ph 2 | completed | CCH Treatment of Cellulite in the Presence of Dermal Laxity With Comparison Between Two (2) Different Injection Techniques |
| NCT03329989 results posted | EN3835-205 | Ph 2 | completed | Safety and Effectiveness of EN3835 in the Treatment of EFP in Women |
| NCT02942160 results posted | EN3835-202 | Ph 2 | completed | EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) |
| NCT02724644 results posted | EN3835-201 | Ph 2 | completed | EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) |
| NCT02193828 results posted | AUX-CC-750 | Ph 2 | completed | Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules |
| NCT01987986 results posted | AUX-CC-831 | Ph 2 | completed | A Phase 2, Randomized, Double-blind, Placebo Controlled Dose Ranging Study of Repeat Doses of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy |
| NCT02006719 AC results posted | AUX-CC-871 | Ph 2 | completed | Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder |
| NCT01498640 results posted | AUX-CC-862 | Ph 4 | completed | Retreatment of Recurrent Dupuytren's Contractures |
| NCT01450397 results posted | 11052 | Ph 4 | completed | MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex |
| NCT01588353 CORD-J results posted | AK160-III-1 | Ph 3 | completed | Collagenase Option for Reduction of Dupuytren's Contracture in Japan |
| NCT01613313 results posted | Lipoma DE/01 | Ph 2 | completed | A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma |
| NCT01518907 | AUX-CC-830 | Ph 1 | completed | The Safety, Effectiveness, and Pharmacokinetics of AA4500 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XIAFLEX FDA Label Details
Indications & Usage
FDA Label (PDF)XIAFLEX is indicated for the treatment of Dupuytren’s Contracture; Peyronie’s Disease.
WARNING: CORPORAL RUPTURE (PENILE FRACTURE) OR OTHER SERIOUS PENILE INJURY IN THE TREATMENT OF PEYRONIE’S DISEASE Corporal rupture (penile fracture) was reported as an adverse reaction in 5 of 1044 (0.5%) XIAFLEX-treated patients in clinical studies. In other XIAFLEX-treated patients (9 of 1044; 0.9...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment