XIAFLEX
XIAFLEX is a combination of bacterial collagenases indicated for the treatment of adult patients with Dupuytren’s contracture who have a palpable cord. It is also approved for the treatment of adult men with Peyronie’s disease who present with a palpable plaque and a curvature deformity of at least 30 degrees. The drug serves as a targeted enzymatic intervention to address physical deformities caused by collagen accumulation in the hand or penis.
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.
Details
- Status
- Prescription
- First Approved
- 2010-02-02
- 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 )
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
ProIndications & Usage
FDA Label (PDF)XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicated 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. XIAFLEX is a combination of bacterial collagenases indicated for: The treatment of adult patients with Dupuytren’s contracture with a palpable cord 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
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.