Collagenase clostridium histolyticum

Identification

Summary

Collagenase clostridium histolyticum is a collagenase enzyme used to promote debridement of necrotic tissue in burns and skin ulcers as well as to treat Dupuytren's contracture and Peyronie's disease.

Brand Names

Qwo, Santyl, Xiaflex

Generic Name

Collagenase clostridium histolyticum

DrugBank Accession Number

DB00048

Background

Collagenase clostridium histolyticum is an enzyme produced by the bacterium Clostridium histolyticum. It is beneficial in the breakdown of collagen plaques for the treatment of Dupuytren's contracture and Peyronie's disease.¹¹ The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers.¹⁴

On July 6, 2020 a combination of injectable bacterial collagenases was approved by the FDA for the treatment of cellulite in adult women.¹⁰ Also known as Qwo, this injection is the first approved injectable treatment for cellulite and was developed by Endo International.¹³

Type

Biotech

Groups

Approved, Investigational

Biologic Classification

Protein Based Therapies
Other protein based therapies

Protein Structure

Protein Chemical Formula

C₅₀₂₈H₇₆₆₆N₁₃₀₀O₁₅₆₄S₂₁

Protein Average Weight

112023.2 Da

Sequences

> Collagenase Sequence 
MKRKCLSKRLMLAITMATIFTVNSTLPIYAAVDKNNATAAVQNESKRYTVSYLKTLNYYD
LVDLLVKTEIENLPDLFQYSSDAKEFYGNKTRMSFIMDEIGRRAPQYTEIDHKGIPTLVE
VVRAGFYLGFHNKELNEINKRSFKERVIPSILAIQKNPNFKLGTEVQDKIVSATGLLAGN
ETAPPEVVNNFTPILQDCIKNIDRYALDDLKSKALFNVLAAPTYDITEYLRATKEKPENT
PWYGKIDGFINELKKLALYGKINDNNSWIIDNGIYHIAPLGKLHSNNKIGIETLTEVMKV
YPYLSMQHLQSADQIKRHYDSKDAEGNKIPLDKFKKEGKEKYCPKTYTFDDGKVIIKAGA
RVEEEKVKRLYWASKEVNSQFFRVYGIDKPLEEGNPDDILTMVIYNSPEEYKLNSVLYGY
DTNNGGMYIEPEGTFFTYEREAQESTYTLEELFRHEYTHYLQGRYAVPGQWGRTKLYDND
RLTWYEEGGAELFAGSTRTSGILPRKSIVSNIHNTTRNNRYKLSDTVHSKYGASFEFYNY
ACMFMDYMYNKDMGILNKLNDLAKNNDVDGYDNYIRDLSSNYALNDKYQDHMQERIDNYE
NLTVPFVADDYLVRHAYKNPNEIYSEISEVAKLKDAKSEVKKSQYFSTFTLRGSYTGGAS
KGKLEDQKAMNKFIDDSLKKLDTYSWSGYKTLTAYFTNYKVDSSNRVTYDVVFHGYLPNE
GDSKNSLPYGKINGTYKGTEKEKIKFSSEGSFDPDGKIVSYEWDFGDGNKSNEENPEHSY
DKVGTYTVKLKVTDDKGESSVSTTTAEIKDLSENKLPVIYMHVPKSGALNQKVVFYGKGT
YDPDGSIAGYQWDFGDGSDFSSEQNPSHVYTKKGEYTVTLRVMDSSGQMSEKTMKIKITD
PVYPIGTEKEPNNSKETASGPIVPGIPVSGTIENTSDQDYFYFDVITPGEVKIDINKLGY
GGATWVVYDENNNAVSYATDDGQNLSGKFKADKPGRYYIHLYMFNGSYMPYRINIEGSVG
R

Download FASTA Format

Synonyms

• Clostridiopeptidase A
• Clostridium histolyticum enzymes
• Collagenase
• Collagenase clostridium histolyticum
• collagenase clostridium histolyticum-aaes

External IDs

• AA-4500
• AA4500
• PF-5076985

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Pharmacology

Indication

Collagenase clostridium histolyticum is indicated for the treatment of adults with Dupuytren's contracture with a palpable cord. Additionally, it is used to treat men with Peyronie's disease diagnosed with a penile curvature deformity of at least a 30-degree angle at the beginning of therapy in addition to palpable plaques.¹¹ Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues.¹⁵ The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.¹⁰

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Associated Conditions

Indication Type	Indication	Combined Product Details	Approval Level	Age Group	Patient Characteristics	Dose Form
Management of	Dupuytren’s contracture		••••••••••••	•••••	•••••••• ••••	•••••••••
Management of	Peyronie’s disease		••••••••••••	•••••	•• ••••• •• •••••• ••••• •••••• •••••••••• •••••••• ••••••••••• •••••••	•••••••••
Treatment of	Necrotic tissue		••••••••••••			••••••••
Treatment of	Necrotic tissue		••••••••••••			••••••••

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Pharmacodynamics

Collagenase digests collagen, treating conditions such as Peyronie's disease, cellulite, chronic ulcers, burns, and contractures.^10,11,14

Mechanism of action

Peyronie's disease is a fibrous lesion of the tunica albuginea in the penile tissues.⁴ Cellulite is a multifactorial condition resulting in the accumulation of fibrotic dermal septae and the expansion of subcutaneous fat.³ Dupuytren's contracture is a fibroproliferative disease that results in the fibrous deposition of collagen in the hands, limiting mobility and functionality of the hands.⁵ The collagen deposition in the abovementioned conditions is the target of collagenase enzyme therapy.^6,7

These enzymes are proteinases acting to hydrolyze collagen's triple-helical conformation, resulting in the lysis of collagen deposits and relief from the necrotic tissue and plaques associated with several conditions.^11,14 On a molecular level, collagenases cleave polypeptide chains that make up the collagen triple helix structure at various loci, leading to solubilization from the collagen fibril.⁸

Target	Actions	Organism
ACollagen alpha-1(I) chain	binder	Humans
ACollagen alpha-1(II) chain	binder	Humans
ACollagen alpha-1(III) chain	binder	Humans

Absorption

There is currently limited readily available regarding the absorption of collagenase through the skin.¹⁴ In a pharmacokinetic study, the serum concentrations of clostridium type I collagenase (AUX-I) and clostridium type II collagenase (AUX-II) were measured. Both were detected under the lower limit of quantitation of 5 ng/mL and 25 ng/mL, respectively, in volunteers administered one dose of the collagenase histolyticum combination product, Qwo, at a dose of up to 3.36 mg in a maximum of 4 body areas.¹⁰

Volume of distribution

There is no currently available information regarding the presence of collagenase in body fluids or uptake by particular organs and passage through the blood-brain barrier.¹⁴ Systemic pharmacokinetic studies evaluation volume of distribution have not been performed, however, collagenase histolyticum is likely to have local degradative effects in the region of the application without effects on the vasculature and elastic tissue.⁹

Protein binding

There is no readily available information regarding the protein binding of collagenase.¹⁴

Metabolism

No formal systemic metabolism studies have been performed with collagenase histolyticum.⁹

Route of elimination

Not Available

Half-life

Not Available

Clearance

Clearance information for collagenase is not readily available.¹⁴

Adverse Effects

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Toxicity

No clinical reaction has been attributed to an overdose of collagenase in clinical trials.¹⁴ If required, the collagenase enzymes can be inactivated with a povidone-iodine wash.¹⁴

Pathways

Not Available

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Not Available

Interactions

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This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
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Abciximab	The risk or severity of adverse effects can be increased when Abciximab is combined with Collagenase clostridium histolyticum.
Acenocoumarol	The risk or severity of adverse effects can be increased when Acenocoumarol is combined with Collagenase clostridium histolyticum.
Alteplase	The risk or severity of adverse effects can be increased when Alteplase is combined with Collagenase clostridium histolyticum.
Ancrod	The risk or severity of adverse effects can be increased when Ancrod is combined with Collagenase clostridium histolyticum.
Anistreplase	The risk or severity of adverse effects can be increased when Anistreplase is combined with Collagenase clostridium histolyticum.

Food Interactions

No interactions found.

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International/Other Brands

Cordase

Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
Collagenase Santyl	Ointment	250 [arb'U]/1g	Topical	SMITH & NEPHEW, INC	2006-10-18	Not applicable
Collagenase Santyl	Ointment	250 [arb'U]/1g	Topical	Healthpoint	2006-10-18	2017-06-30
Qwo	Injection, powder, lyophilized, for solution	0.23 mg/1mL	Intralesional	Endo Aesthetics LLC	2021-02-01	2025-01-31
Santyl	Ointment	250 unit / g	Topical	Smith & Nephew, Inc.	1994-12-31	Not applicable
Xiaflex	Powder, for solution	0.9 mg / vial	Intralesional	Endo Ventures Ltd	2012-11-14	2020-06-11

Over the Counter Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End	Region	Image
IRUXOL MONO	Ointment	1.2 IU	Topical	SMITH & NEPHEW HEALTHCARE SDN BHD	2020-09-08	Not applicable

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Kimchi Vitamin chewable multivitamin	Collagenase clostridium histolyticum (5.625 mg/1) + Ascorbic acid (180 mg/1) + Cholecalciferol (0.375 mg/1) + Folic acid (0.03 mg/1) + Lactic acid (30 mg/1) + Nicotinamide (0.045 mg/1) + Pyridoxine (0.285 mg/1) + Riboflavin (0.24 mg/1) + Thiamine chloride (0.195 mg/1) + Vitamin A (0.675 mg/1) + Vitamin E (1.875 mg/1)	Tablet, chewable	Oral	Tobico	2010-03-18	Not applicable

Unapproved/Other Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End	Region	Image
Kimchi Vitamin chewable multivitamin	Collagenase clostridium histolyticum (5.625 mg/1) + Ascorbic acid (180 mg/1) + Cholecalciferol (0.375 mg/1) + Folic acid (0.03 mg/1) + Lactic acid (30 mg/1) + Nicotinamide (0.045 mg/1) + Pyridoxine (0.285 mg/1) + Riboflavin (0.24 mg/1) + Thiamine chloride (0.195 mg/1) + Vitamin A (0.675 mg/1) + Vitamin E (1.875 mg/1)	Tablet, chewable	Oral	Tobico	2010-03-18	Not applicable

Categories

ATC Codes

D03BA02 — Collagenase

• D03BA — Proteolytic enzymes
• D03B — ENZYMES
• D03 — PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS
• D — DERMATOLOGICALS

M09AB02 — Collagenase clostridium histolyticum

• M09AB — Enzymes
• M09A — OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
• M09 — OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
• M — MUSCULO-SKELETAL SYSTEM

D03BA52 — Collagenase, combinations

• D03BA — Proteolytic enzymes
• D03B — ENZYMES
• D03 — PREPARATIONS FOR TREATMENT OF WOUNDS AND ULCERS
• D — DERMATOLOGICALS

Drug Categories

• Collagen-specific Enzyme
• Collagenases
• Dermatologicals
• Endopeptidases
• Enzymes
• Enzymes and Coenzymes
• Hydrolases
• Metalloendopeptidases
• Metalloproteases
• Microbial Collagenase, antagonists & inhibitors
• Misc. Skin and Mucous Membrane Agents
• Musculo-Skeletal System
• Peptide Hydrolases
• Preparations for Treatment of Wounds and Ulcers

Chemical TaxonomyProvided by Classyfire

Description

Not Available

Kingdom

Organic Compounds

Super Class

Organic Acids

Class

Carboxylic Acids and Derivatives

Sub Class

Amino Acids, Peptides, and Analogues

Direct Parent

Peptides

Alternative Parents

Not Available

Substituents

Not Available

Molecular Framework

Not Available

External Descriptors

Not Available

Affected organisms

• Humans and other mammals

Chemical Identifiers

UNII

9X7O8V25IT

CAS number

9001-12-1

References

Synthesis Reference

Hun-Chi Lin, Shau-Ping Lei, "Molecular cloning of the genes responsible for collagenase production from Clostridium histolyticum." U.S. Patent US5177017, issued December, 1972.

US5177017

General References

1. Norris DB, Trudgill PW: Multiple forms of cyclohexanone oxygenase from Nocardia globerula CL1. Eur J Biochem. 1976 Mar 16;63(1):193-8. [Article]
2. Pajot P: Fluroescence of proteins in 6-M guanidine hydrochloride. A method for the quantitative determination of tryptophan. Eur J Biochem. 1976 Mar 16;63(1):263-9. [Article]
3. Rossi AM, Katz BE: A modern approach to the treatment of cellulite. Dermatol Clin. 2014 Jan;32(1):51-9. doi: 10.1016/j.det.2013.09.005. [Article]
4. Randhawa K, Shukla CJ: Non-invasive treatment in the management of Peyronie's disease. Ther Adv Urol. 2019 Feb 11;11:1756287218823671. doi: 10.1177/1756287218823671. eCollection 2019 Jan-Dec. [Article]
5. Grazina R, Teixeira S, Ramos R, Sousa H, Ferreira A, Lemos R: Dupuytren's disease: where do we stand? EFORT Open Rev. 2019 Feb 20;4(2):63-69. doi: 10.1302/2058-5241.4.180021. eCollection 2019 Feb. [Article]
6. Dhillon S: Collagenase Clostridium Histolyticum: A Review in Peyronie's Disease. Drugs. 2015 Aug;75(12):1405-12. doi: 10.1007/s40265-015-0441-7. [Article]
7. Kaplan FT: Collagenase clostridium histolyticum injection for the treatment of Dupuytren's contracture. Drugs Today (Barc). 2011 Sep;47(9):653-67. doi: 10.1358/dot.2011.47.9.1656502. [Article]
8. Krane SM: Collagenases and collagen degradation. J Invest Dermatol. 1982 Jul;79 Suppl 1:83s-86s. doi: 10.1111/1523-1747.ep12545849. [Article]
9. Andrew J Watt, Vincent R Hentz: Collagenase clostridium histolyticum: a novel nonoperative treatment for Dupuytren’s disease Int. J. Clin. Rheumatol.. [Article]
10. FDA Approved Products: Qwo (collagenase clostridium histolyticum-aaes) for subcutaneous injection [Link]
11. FDA Approved Products: Ziaflex (collagenase clostridium histolyticum) for intralesional use [Link]
12. Thermo Fisher SDS: Collagenase, Type II Powder [Link]
13. Endo International website [Link]
14. FDA Approved Products: Santyl (collagenase) ointment [Link]
15. Product monograph: Santyl (collagenase) [Link]

External Links

KEGG Compound

C00816

PubChem Substance

46506485

RxNav

58939

Therapeutic Targets Database

DAP000965

PharmGKB

PA449107

RxList

RxList Drug Page

Drugs.com

Drugs.com Drug Page

Wikipedia

Collagenase

MSDS

Download (72.9 KB)

Clinical Trials

Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
4	Active Not Recruiting	Treatment	Dupuytren's Contracture of the Hand (Viking's Disease)	1
4	Active Not Recruiting	Treatment	Dupuytren's Disease of Finger	1
4	Active Not Recruiting	Treatment	Peyronie's Disease	1
4	Completed	Basic Science	Impaired Wound Healing / Scarring	1
4	Completed	Diagnostic	Diabetic Foot Ulcers (DFUs)	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

• Abbott Laboratories Ltd.
• Advance Biofactures Corp.
• Auxilium Pharmaceuticals
• BASF Corp.
• Dispensing Solutions
• Healthpoint Ltd.
• Medisca Inc.

Dosage Forms

Form	Route	Strength
Ointment	Topical	250 [arb'U]/1g
Ointment	Topical
Ointment	Topical	120 IU
Ointment	Topical	1.2 IU
Ointment	Topical	1.2 u/g
Tablet, chewable	Oral
Injection, powder, lyophilized, for solution	Intralesional	0.23 mg/1mL
Ointment	Topical	250 unit / g
Ointment	Topical	1.2 U
Injection, powder, lyophilized, for solution; kit	Intralesional	0.9 mg/1
Powder, for solution	Intralesional	0.9 mg / vial
Injection, powder, for solution	Intralesional	0.9 mg
Powder	Intralesional	0.9 MG
Ointment	Topical	1.2 units/g

Prices

Unit description	Cost	Unit
Xiaflex 0.9 mg vial	3900.0USD	vial
Collagenase powder	2432.7USD	g
Santyl 250 unit/gm Ointment 15 gm Tube	62.98USD	tube
Santyl ointment	4.13USD	g

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.

Patents

Not Available

Properties

State

Solid

Experimental Properties

Property	Value	Source
melting point (°C)	49-54	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3406112/
hydrophobicity	-0.714	Not Available
isoelectric point	5.35-6.20	https://pubs.acs.org/doi/pdfplus/10.1021/bi00308a036?src=recsys

Targets

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Details1. Collagen alpha-1(I) chain

Kind

Protein

Organism

Humans

Pharmacological action

Yes

Actions

Binder

Curator comments

Collagenase targets many types of collagen chains. This chain has been selected as a representative collagen chain, though others may also be targeted.

General Function

Platelet-derived growth factor binding

Specific Function

Type I collagen is a member of group I collagen (fibrillar forming collagen).

Gene Name

COL1A1

Uniprot ID

P02452

Uniprot Name

Collagen alpha-1(I) chain

Molecular Weight

138941.105 Da

References

1. Egeblad M, Shen HC, Behonick DJ, Wilmes L, Eichten A, Korets LV, Kheradmand F, Werb Z, Coussens LM: Type I collagen is a genetic modifier of matrix metalloproteinase 2 in murine skeletal development. Dev Dyn. 2007 Jun;236(6):1683-93. [Article]
2. Lindsey ML, Yoshioka J, MacGillivray C, Muangman S, Gannon J, Verghese A, Aikawa M, Libby P, Krane SM, Lee RT: Effect of a cleavage-resistant collagen mutation on left ventricular remodeling. Circ Res. 2003 Aug 8;93(3):238-45. Epub 2003 Jul 10. [Article]
3. Beare AH, O'Kane S, Krane SM, Ferguson MW: Severely impaired wound healing in the collagenase-resistant mouse. J Invest Dermatol. 2003 Jan;120(1):153-63. [Article]
4. Chiu CJ, Chang ML, Chiang CP, Hahn LJ, Hsieh LL, Chen CJ: Interaction of collagen-related genes and susceptibility to betel quid-induced oral submucous fibrosis. Cancer Epidemiol Biomarkers Prev. 2002 Jul;11(7):646-53. [Article]
5. Beare AH, Krane SM, Ferguson MW: Variable impairment of wound healing in the heterozygous collagenase-resistant mouse. Wound Repair Regen. 2005 Jan-Feb;13(1):27-40. [Article]

Details2. Collagen alpha-1(II) chain

Kind

Protein

Organism

Humans

Pharmacological action

Yes

Actions

Binder

Curator comments

Collagenase targets many types of collagen chains. This chain has been selected as a representative collagen chain, though others may also be targeted.

General Function

Platelet-derived growth factor binding

Specific Function

Type II collagen is specific for cartilaginous tissues. It is essential for the normal embryonic development of the skeleton, for linear growth and for the ability of cartilage to resist compressiv...

Gene Name

COL2A1

Uniprot ID

P02458

Uniprot Name

Collagen alpha-1(II) chain

Molecular Weight

141785.08 Da

References

1. Fraser A, Fearon U, Billinghurst RC, Ionescu M, Reece R, Barwick T, Emery P, Poole AR, Veale DJ: Turnover of type II collagen and aggrecan in cartilage matrix at the onset of inflammatory arthritis in humans: relationship to mediators of systemic and local inflammation. Arthritis Rheum. 2003 Nov;48(11):3085-95. [Article]
2. Imai K, Dalal SS, Hambor J, Mitchell P, Okada Y, Horton WC, D'Armiento J: Bone growth retardation in mouse embryos expressing human collagenase 1. Am J Physiol Cell Physiol. 2007 Oct;293(4):C1209-15. Epub 2007 Jul 25. [Article]
3. Verstappen SM, Poole AR, Ionescu M, King LE, Abrahamowicz M, Hofman DM, Bijlsma JW, Lafeber FP: Radiographic joint damage in rheumatoid arthritis is associated with differences in cartilage turnover and can be predicted by serum biomarkers: an evaluation from 1 to 4 years after diagnosis. Arthritis Res Ther. 2006;8(1):R31. Epub 2006 Jan 10. [Article]
4. Martin G, Bogdanowicz P, Domagala F, Ficheux H, Pujol JP: Articular chondrocytes cultured in hypoxia: their response to interleukin-1beta and rhein, the active metabolite of diacerhein. Biorheology. 2004;41(3-4):549-61. [Article]
5. Pratta MA, Yao W, Decicco C, Tortorella MD, Liu RQ, Copeland RA, Magolda R, Newton RC, Trzaskos JM, Arner EC: Aggrecan protects cartilage collagen from proteolytic cleavage. J Biol Chem. 2003 Nov 14;278(46):45539-45. Epub 2003 Jul 30. [Article]

Details3. Collagen alpha-1(III) chain

Kind

Protein

Organism

Humans

Pharmacological action

Yes

Actions

Binder

Curator comments

Collagenase targets many types of collagen chains. This chain has been selected as a representative collagen chain, though others may also be targeted.

General Function

Platelet-derived growth factor binding

Specific Function

Collagen type III occurs in most soft connective tissues along with type I collagen. Involved in regulation of cortical development. Is the major ligand of GPR56 in the developing brain and binding...

Gene Name

COL3A1

Uniprot ID

P02461

Uniprot Name

Collagen alpha-1(III) chain

Molecular Weight

138564.005 Da

References

1. Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6. [Article]
2. Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34. [Article]
3. Cole WG, Chiodo AA, Lamande SR, Janeczko R, Ramirez F, Dahl HH, Chan D, Bateman JF: A base substitution at a splice site in the COL3A1 gene causes exon skipping and generates abnormal type III procollagen in a patient with Ehlers-Danlos syndrome type IV. J Biol Chem. 1990 Oct 5;265(28):17070-7. [Article]

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Drug created at June 13, 2005 13:24 / Updated at February 21, 2024 02:33