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Collagenase Santyl Vehicle
Collagenase enzymatically breaks down collagen in necrotic tissue, facilitating debridement of wounds.
Collagenase Santyl Vehicle, marketed by Healthpoint, is a well-established product in the debridement market. A key strength is the protection provided by its composition patent, which does not expire until 2028. The primary risk is the lack of recent trial results to support ongoing efficacy and safety claims, potentially impacting market confidence.
At a glance
| Generic name | Collagenase Santyl Vehicle |
|---|---|
| Sponsor | Healthpoint |
| Drug class | Enzymatic debridement agent |
| Target | Collagen (fibrous protein substrate) |
| Modality | Small molecule |
| Therapeutic area | Wound Care / Dermatology |
| Phase | FDA-approved |
Mechanism of action
Collagenase is a protease enzyme that specifically cleaves collagen, the primary structural protein in necrotic (dead) tissue. By degrading collagen in the wound bed, it selectively removes devitalized tissue while preserving healthy tissue, promoting wound healing and facilitating the natural debridement process. The Santyl vehicle formulation provides a stable delivery system for topical application.
Approved indications
- Debridement of necrotic tissue in chronic wounds (pressure ulcers, diabetic ulcers, venous ulcers)
- Burn wounds
Common side effects
- Bleeding or increased wound drainage
- Erythema at application site
- Dermatitis or skin irritation
Key clinical trials
- Clinical Study to Evaluate the Safety and the Efficacy of EscharEx Drug Product (EX-03 Formulation) and Its Placebo Compared to Collagenase, Non-surgical Standard of Care, in Patients With Venous Leg Ulcers (PHASE2)
- A Study to Evaluate the Safety and the Efficacy of EscharEx (EX-02 Formulation) in Debridement of Venous Leg Ulcers (PHASE2)
- Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers. (PHASE3)
- Wound Edge Changes Following Treatment With Santyl (PHASE4)
- A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers (PHASE4)
- Effect of Collagenase on Healing and Scarring (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Collagenase Santyl Vehicle CI brief — competitive landscape report
- Collagenase Santyl Vehicle updates RSS · CI watch RSS
- Healthpoint portfolio CI