THERAPY DOSSIER · th-88331a0ae2a1

Collagenase Santyl Ointment (clostridial collagenase), active ingredient CS-API

Biologic · Collagen hydrolytic enzyme (HYDROLYTIC ENZYME)

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Evidence & regulatory context

Mechanism: Collagen hydrolytic enzyme (HYDROLYTIC ENZYME)
Target: CHEMBL2364188
Injury models: Wound
Reported indication: Not recorded
First approval: 2010
Development stage: Not recorded
ChEMBL record: CHEMBL2108709 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: AA-4500; AA4500; Clostridial collagenase; Clostridium histolyticum enzymes; Collagenase; Collagenase clostridium histolyticum; Collagenase clostridium histolyticum aaes; Cordase; Iruxol; MZ-004; Plaquase; Qwo; Santyl; Xiaflex; Xiapex
Note: Not recorded

Clinical trials 8

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT01229436 ↗PHASE3completed

Non-surgical Treatment With CCH (Xiapex)

Dupuytren's Contracture

Enrolment: 254 · Results not recorded

NCT01221597 ↗PHASE3completed

AA4500 (2x4) in Men With Peyronie's Disease

Peyronie's Disease

Enrolment: 418 · Results not recorded

NCT02724644 ↗PHASE2completed

EN3835 (CCH) for Cellulite

Edematous Fibrosclerotic Panniculopathy · Cellulite

Enrolment: 375 · Results not recorded

NCT01430169 ↗PHASE2completed

AA4500 0.58 mg in Men With Peyronie's Disease (PK)

Peyronie's Disease

Enrolment: 20 · Results not recorded

NCT00261209 ↗PHASE1/PHASE2completed

Collagenase Injection for Zone II Flexor Tendon Adhesions

Adhesion of Flexor Tendon of Hand

Enrolment: 3 · Results not recorded

NCT01538017 ↗NAcompleted

Injectable Collagenase vs Percutaneous Needle Fasciotomy for Dupuytren's

Dupuytrens Contracture

Enrolment: 50 · Results not recorded

NCT06065436 ↗NArecruiting

Shockwave With CCH in Peyronie's Disease

Peyronie Disease · Erectile Dysfunction

Enrolment: 60 · Results not recorded

NCT05646602 ↗NAwithdrawn

Focused LiSWT +/- Clostridial Collagenase (Xiaflex)

Peyronie Disease · Penile Curvature · Erectile Dysfunction

Enrolment: 0 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 29374192 ↗2018Reported benefit

Novel mechanisms of Collagenase Santyl Ointment (CSO) in wound macrophage polarization and resolution of wound inflammation.

MouseWoundC57BL/6 and BKS.Cg-m +/+ Leprdb/J (db/db)MaleTopical, loaded into implanted subcutaneous PVA sponges300 mg CSO per sponge; CS-API 250 ng/mL in vitroLoaded into sponges at the time of implantation, that is at wounding

Model: Subcutaneous implantation of 8 mm sterile PVA sponges with sutured incisional wounds; acute wound model in C57BL/6 and chronic diabetic wound model in db/db mice

CSO and CS-API shifted wound macrophages toward a pro-reparative phenotype with higher IL-10 and TGF-beta and lower TNF-alpha and IL-1beta in both acute and diabetic wounds, acting through PGE2-EP4-dependent STAT6 activation.

Extraction: extract · Supplied extraction confidence: 0.85. Machine-extracted fields require source verification.

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