{"id":"collagenase","rwe":[{"pmid":"41903787","year":"2026","title":"Systemic administration of osteoblast-derived collagenase released extracellular vesicles restores trabecular bone loss in ovariectomized mice.","finding":"","journal":"Bone","studyType":"Clinical Study"},{"pmid":"41901281","year":"2026","title":"From Extraction to Cryobanking: Which Critical Process Parameters Genuinely Improve DPSC Production?","finding":"","journal":"Pharmaceuticals (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41898281","year":"2026","title":"An In Vitro Study on the Efficacy of Green Synthesized Silver Nanoparticles on Surgical Site Infections and Healings.","finding":"","journal":"Biomedicines","studyType":"Clinical Study"},{"pmid":"41893413","year":"2026","title":"A 3D Organotypic Human Bronchial Model Reveals Persistent Infection and Modulated Inflammatory Response when Exposed to Brucella abortus.","finding":"","journal":"Tropical medicine and infectious disease","studyType":"Clinical Study"},{"pmid":"41889224","year":"2026","title":"Paraquat Dichloride Induced Cytotoxicity in Primary Hepatocytes via an Antioxidative and Mitochondrial-Dependent Pathway.","finding":"","journal":"Journal of applied toxicology : JAT","studyType":"Clinical Study"}],"_fda":{"id":"155959d1-0367-4fb6-8877-29099d08801c","set_id":"6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd","openfda":{"upc":["0350484010300"],"unii":["9X7O8V25IT"],"route":["TOPICAL"],"rxcui":["309509"],"spl_id":["155959d1-0367-4fb6-8877-29099d08801c"],"brand_name":["COLLAGENASE SANTYL"],"spl_set_id":["6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffd"],"package_ndc":["50484-010-30","50484-010-90"],"product_ndc":["50484-010"],"generic_name":["COLLAGENASE SANTYL"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["COLLAGENASE CLOSTRIDIUM HISTOLYTICUM"],"manufacturer_name":["SMITH & NEPHEW, INC"],"application_number":["BLA101995"],"is_original_packager":[true]},"version":"3","overdosage":["OVERDOSAGE No systemic or local reaction attributed to overdose has been observed in clinical investigations and clinical use. If deemed necessary the enzyme may be inactivated by washing the area with povidone iodine."],"description":["DESCRIPTION Collagenase Santyl ◊ Ointment is a sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum . It possesses the unique ability to digest collagen in necrotic tissue."],"precautions":["PRECAUTIONS The optimal pH range of collagenase is 6 to 8. Higher or lower pH conditions will decrease the enzyme’s activity and appropriate precautions should be taken. The enzymatic activity is also adversely affected by certain detergents, and heavy metal ions such as mercury and silver which are used in some antiseptics. When it is suspected such materials have been used, the site should be carefully cleansed by repeated washings with normal saline before Collagenase Santyl ◊ Ointment is applied. Soaks containing metal ions or acidic solutions should be avoided because of the metal ion and low pH. Cleansing materials such as Dakin’s solution and normal saline are compatible with Collagenase Santyl ◊ Ointment. Debilitated patients should be closely monitored for systemic bacterial infections because of the theoretical possibility that debriding enzymes may increase the risk of bacteremia. A slight transient erythema has been noted occasionally in the surrounding tissue, particularly when Collagenase Santyl ◊ Ointment was not confined to the wound. Therefore, the ointment should be applied carefully within the area of the wound. Safety and effectiveness in pediatric patients have not been established."],"how_supplied":["HOW SUPPLIED Collagenase Santyl ◊ Ointment contains 250 units of collagenase enzyme per gram of white petrolatum USP. Do not store above 25°C (77°F). Sterility guaranteed until tube is opened. Collagenase Santyl ◊ Ointment is available in the following sizes: 30 g tube NDC 50484-010-30 90 g tube NDC 50484-010-90 REFERENCES 1 – Mandl, I., Adv Enzymol. 23:163, 1961. 2 – Boxer, A.M., Gottesman, N., Bernstein, H., & Mandl, I., Geriatrics. 24:75, 1969. 3 – Mazurek, I., Med. Welt. 22:150, 1971. 4 – Zimmermann, WE., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 131, p. 185. 5 – Vetra, H., & Whittaker, D., Geriatrics. 30:53, 1975. 6 – Rao, D.B., Sane, P.G., & Georgiev, E.L., J. Am. Geriatrics Soc. 23:22, 1975. 7 – Vrabec, R., Moserova, J., Konickova, Z., Behounkova, E., & Blaha, J., J. Hyg. Epidemiol. Microbiol. Immunol. 18:496, 1974. 8 – Lippmann, H.I., Arch. Phys. Med. Rehabil. 54:588, 1973. 9 – German, F. M., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 165. 10 – Haimovici, H. & Strauch, B., in “Collagenase,” Mandl, I., ed., Gordon & Breach, Science Publishers, New York, 1971, p. 177. 11 – Lee, L.K., & Ambrus, J.L., Geriatrics. 30:91, 1975. 12 – Locke, R.K., & Heifitz, N.M., J. Am. Pod. Assoc. 65:242, 1975. 13 – Varma, A.O., Bugatch, E., & German, F.M., Surg. Gynecol. Obstet. 136:281, 1973. 14 – Barrett, D., Jr., & Klibanski, A., Am. J. Nurs. 73:849, 1973. 15 – Bardfeld, L.A., J. Pod. Ed. 1:41, 1970. 16 – Blum, G., Schweiz, Rundschau Med Praxis. 62:820, 1973. Abstr. in Dermatology Digest, Feb. 1974, p. 36. 17 – Zaruba, F., Lettl, A., Brozkova, L., Skrdlantova, H., & Krs, V., J. Hyg. Epidemiol. Microbiol. Immunol. 18:499, 1974. 18 – Altman, M.I., Goldstein, L., & Horwitz, S., J. Am. Pod. Assoc. 68:11, 1978. 19 – Rehn, V.J., Med. Klin. 58:799, 1963. 20 – Krauss, H., Koslowski, L., & Zimmermann, W. E., Langenbecks Arch. Klin. Chir. 303:23, 1963. 21 – Gruenagel, H.H., Med. Klin. 58:442, 1963. Manufactured by: SMITH & NEPHEW, INC Fort Worth, Texas 76109 US Gov’t License #2004 Marketed by: Smith & Nephew ◊ 1-800-441-8227 Smith & Nephew, Inc., Fort Worth, Texas 76109 © 2016 Smith & Nephew, Inc. SANTYL is a registered trademark of Smith & Nephew, Inc. 140749-0316"],"effective_time":"20190517","adverse_reactions":["ADVERSE REACTIONS No allergic sensitivity or toxic reactions have been noted in clinical use when used as directed. However, one case of systemic manifestations of hypersensitivity to collagenase in a patient treated for more than one year with a combination of collagenase and cortisone has been reported."],"contraindications":["CONTRAINDICATIONS Collagenase Santyl ◊ Ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Since collagen accounts for 75% of the dry weight of skin tissue, the ability of collagenase to digest collagen in the physiological pH and temperature range makes it particularly effective in the removal of detritus. 1 Collagenase thus contributes towards the formation of granulation tissue and subsequent epithelization of dermal ulcers and severely burned areas. 2, 3, 4, 5, 6 Collagen in healthy tissue or in newly formed granulation tissue is not attacked. 2, 3, 4, 5, 6, 7, 8 There is no information available on collagenase absorption through skin or its concentration in body fluids associated with therapeutic and/or toxic effects, degree of binding to plasma proteins, degree of uptake by a particular organ or in the fetus, and passage across the blood brain barrier."],"indications_and_usage":["INDICATIONS AND USAGE Collagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21"],"spl_unclassified_section":["R x only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Collagenase Santyl ◊ Ointment should be applied once daily (or more frequently if the dressing becomes soiled, as from incontinence). When clinically indicated, crosshatching thick eschar with a #10 blade allows Collagenase Santyl ◊ Ointment more surface contact with necrotic debris. It is also desirable to remove, with forceps and scissors, as much loosened detritus as can be done readily. Use Collagenase Santyl ◊ Ointment in the following manner: 1 - Prior to application the wound should be cleansed of debris and digested material by gently rubbing with a gauze pad saturated with normal saline solution, or with the desired cleansing agent compatible with Collagenase Santyl ◊ Ointment (See PRECAUTIONS ), followed by a normal saline solution rinse. 2 - Whenever infection is present, it is desirable to use an appropriate topical antibiotic powder. The antibiotic should be applied to the wound prior to the application of Collagenase Santyl ◊ Ointment. Should the infection not respond, therapy with Collagenase Santyl ◊ Ointment should be discontinued until remission of the infection. 3 - Collagenase Santyl ◊ Ointment may be applied directly to the wound or to a sterile gauze pad which is then applied to the wound and properly secured. 4 - Use of Collagenase Santyl ◊ Ointment should be terminated when debridement of necrotic tissue is complete and granulation tissue is well established."],"spl_product_data_elements":["COLLAGENASE SANTYL COLLAGENASE SANTYL COLLAGENASE CLOSTRIDIUM HISTOLYTICUM COLLAGENASE CLOSTRIDIUM HISTOLYTICUM PETROLATUM WHITE TO OFF WHITE"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2228603f-figure-01","TUBE LABEL.PRINCIPAL DISPLAY PANEL 2228603f-figure-02"]},"tags":[{"label":"Collagen-specific Enzyme","category":"class"},{"label":"Biologic","category":"modality"},{"label":"D03BA02","category":"atc"},{"label":"Topical","category":"route"},{"label":"Oral","category":"route"},{"label":"Intralesional","category":"route"},{"label":"Injection","category":"form"},{"label":"Ointment","category":"form"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"Dupuytren's disease of finger, with contracture","category":"indication"},{"label":"Induratio penis plastica","category":"indication"},{"label":"Advance Biofactures","category":"company"},{"label":"Approved 1960s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1418 reports"},{"date":"","signal":"CONTUSION","source":"FDA FAERS","actionTaken":"666 reports"},{"date":"","signal":"SWELLING","source":"FDA FAERS","actionTaken":"574 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"554 reports"},{"date":"","signal":"PENILE SWELLING","source":"FDA FAERS","actionTaken":"479 reports"},{"date":"","signal":"PENILE CONTUSION","source":"FDA FAERS","actionTaken":"449 reports"},{"date":"","signal":"FRACTURE OF PENIS","source":"FDA FAERS","actionTaken":"445 reports"},{"date":"","signal":"INJECTION SITE PAIN","source":"FDA FAERS","actionTaken":"321 reports"},{"date":"","signal":"PENILE PAIN","source":"FDA FAERS","actionTaken":"311 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"297 reports"}],"commonSideEffects":[{"effect":"Hypersensitivity","drugRate":"reported","severity":"unknown"},{"effect":"Fatigue","drugRate":"reported","severity":"unknown"}],"specialPopulations":{"Pregnancy":"There are no available data on collagenase clostridium histolyticum use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Following subcutaneous injection, the systemic concentrations for QWO were below the bioanalytical assay limit of quantification [see Clinical Pharmacology (12.3)].In animal reproduction studies, intravenous administration of collagenase clostridium histolyticum to pregnant rats during organogenesis at doses up to 0.13 mg/rat (43 human equivalent dose [HED] on mg/kg basis) revealed no evidence of harm to the fetus.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.","Geriatric use":"In two double-blind, placebo-controlled, clinical trials in subjects with cellulite (Trials and 2), 24 (5.7%) of the 424 subjects who received QWO were 65 years of age or older. No overall differences in safety of QWO were observed between these patients and younger patients.","Paediatric use":"The safety and effectiveness of QWO have not been established in pediatric patients."}},"trials":[],"aliases":[],"company":"Advance Biofactures","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=collagenase","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:15:28.212827+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Collagenase","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:15:36.782792+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:15:35.217543+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:15:26.848776+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=collagenase","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:15:36.212592+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:15:25.527085+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:15:25.527182+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:15:37.691712+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Collagen hydrolytic enzyme","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:15:36.782415+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108709/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:15:36.677739+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA101995","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:15:25.527212+00:00"}},"allNames":"xiaflex","offLabel":[],"synonyms":["collagenase","xiaflex","collagenase clostridium histolyticum"],"timeline":[{"date":"1965-06-04","type":"positive","source":"DrugCentral","milestone":"FDA approval (Advance Biofactures)"}],"approvals":[{"date":"1965-06-04","orphan":false,"company":"ADVANCE BIOFACTURES","regulator":"FDA"}],"brandName":"Xiaflex","ecosystem":[{"indication":"Dupuytren's disease of finger, with contracture","otherDrugs":[],"globalPrevalence":null},{"indication":"Induratio penis plastica","otherDrugs":[{"name":"benzoic acid","slug":"benzoic-acid","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Biologic","drugClass":"Collagen-specific Enzyme","explanation":"","oneSentence":"","technicalDetail":"Xiaflex is a collagenase, a type of enzyme that specifically breaks down collagen type I and III, the primary collagen types involved in Dupuytren's disease and Peyronie's disease."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Collagenase","title":"Collagenase","extract":"Collagenases are enzymes that break the peptide bonds in collagen. They assist in destroying extracellular structures in the pathogenesis of bacteria such as Clostridium. They are considered a virulence factor, facilitating the spread of gas gangrene. They normally target the connective tissue in muscle cells and other body organs."},"commercial":{"launchDate":"1965","_launchSource":"DrugCentral (FDA 1965-06-04, ADVANCE BIOFACTURES)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5051","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=collagenase","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=collagenase","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Collagenase","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T10:16:53.989085","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:15:41.113476+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[{"form":"INJECTION, POWDER, LYOPHILIZED, FOR 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