- Raw materials
- Enzyme Replacements/modifiers
- Collagenase clostridium histolyticum
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Collagenase clostridium histolyticum API Manufacturers & Suppliers
1 verified results
All Collagenase clostridium histolyticum data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: 50+
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Collagenase clostridium histolyticum | CAS No: 9001-12-1 | GMP-certified suppliers
A medication that enzymatically treats Dupuytren's contracture, Peyronie's disease, chronic dermal ulcers, severe burns, and moderate to severe cellulite by degrading pathological collagen deposits.
Therapeutic categories
Primary indications
- 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
- Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues
Product Snapshot
- Collagenase clostridium histolyticum is available in various formulations including injectable powder for solution, topical ointments, patches, and oral chewable tablets
- It is primarily used for enzymatic tissue debridement, treatment of Dupuytren's contracture, Peyronie's disease, and moderate to severe cellulite
- The product is approved or investigational in key regulatory markets such as the US, Canada, and the EU
Clinical Overview
Clinically, this enzyme is indicated for the treatment of Dupuytren's contracture in adults presenting with a palpable cord, and for men diagnosed with Peyronie's disease characterized by penile curvature deformities of 30 degrees or greater alongside palpable fibrous plaques. Additionally, topical collagenase formulations are indicated for the enzymatic debridement of necrotic tissue in chronic dermal ulcers and severe burns. A combination injectable collagenase product, commercially known as Qwo, received FDA approval in 2020 for moderate to severe cellulite of the buttocks in adult women.
Pharmacodynamically, collagenase clostridium histolyticum functions by catalyzing the cleavage of peptide bonds in collagen, facilitating the breakdown of fibrotic collagenous plaques and necrotic tissue. This mechanism addresses pathological collagen accumulation in Dupuytren’s contracture, Peyronie’s disease, cellulite, and wounds requiring debridement.
Regarding absorption, distribution, metabolism, and excretion (ADME), collagenase clostridium histolyticum is administered intracordally, intralesionally, or topically depending on the indication. As a protein enzyme, systemic absorption is minimal when applied topically. Enzyme activity is localized at the target sites, and metabolic degradation typically involves proteolytic breakdown, with a limited systemic half-life.
Safety considerations include potential localized adverse reactions such as injection site hematoma, swelling, and pain. Musculoskeletal injuries, including tendon rupture, have been reported, necessitating careful administration. Immunogenicity and hypersensitivity reactions are potential risks due to its bacterial protein nature.
From an API sourcing perspective, quality attributes must include high enzymatic activity, purity with minimal endotoxin levels, and absence of proteolytic contaminants that could affect stability or safety. Manufacturing processes require stringent controls to ensure batch-to-batch consistency, sterility, and compliance with pharmacopeial standards for enzyme preparations used in clinical applications.
Identification & chemistry
| Generic name | Collagenase clostridium histolyticum |
|---|---|
| Molecule type | Biotech |
| CAS | 9001-12-1 |
| UNII | 9X7O8V25IT |
| DrugBank ID | DB00048 |
Pharmacology
| Summary | Collagenase enzymes hydrolyze the triple-helical structure of collagen types I, II, and III, leading to the degradation of fibrotic collagen deposits. This enzymatic activity targets pathological collagen accumulation in conditions such as Dupuytren's contracture, Peyronie's disease, cellulite, chronic ulcers, and burns. Therapeutically, collagenase facilitates the breakdown of fibrotic plaques and necrotic tissue to improve tissue remodeling and function. |
|---|---|
| Mechanism of action | Peyronie's disease is a fibrous lesion of the tunica albuginea in the penile tissues. Cellulite is a multifactorial condition resulting in the accumulation of fibrotic dermal septae and the expansion of subcutaneous fat. 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. The collagen deposition in the abovementioned conditions is the target of collagenase enzyme therapy. 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. 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. |
| Pharmacodynamics | Collagenase digests collagen, treating conditions such as Peyronie's disease, cellulite, chronic ulcers, burns, and contractures. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Collagen alpha-1(I) chain | Humans | binder |
| Collagen alpha-1(II) chain | Humans | binder |
| Collagen alpha-1(III) chain | Humans | binder |
ADME / PK
| Absorption | There is currently limited readily available regarding the absorption of collagenase through the skin. 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. |
|---|---|
| Protein binding | There is no readily available information regarding the protein binding of collagenase. |
| Metabolism | No formal systemic metabolism studies have been performed with collagenase histolyticum. |
| 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. 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. |
| Clearance | Clearance information for collagenase is not readily available. |
Formulation & handling
- Collagenase clostridium histolyticum is a biotech peptide enzyme available for intralesional injection, topical, cutaneous, and oral administration requiring appropriate formulation to maintain enzymatic activity.
- Lyophilized powder forms for injection require reconstitution prior to intralesional use and careful handling to preserve stability and efficacy.
- Topical and cutaneous formulations such as ointments and patches must ensure enzyme stability and controlled release without degradation by environmental factors.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently off-patent in the US, Canada, and the EU, allowing for generic competition and widespread market availability. These markets exhibit mature product life cycles with established regulatory frameworks for both brand-name and generic formulations. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Collagenase clostridium histolyticum is supplied by multiple packagers, including Abbott Laboratories Ltd. and BASF Corp., indicating a diverse manufacturing base. The product is marketed across the US, Canada, and the EU, with several branded formulations available. Patent expiry in this category may facilitate the presence or entry of generic competition in these markets. |
|---|
Safety
| Toxicity | No clinical reaction has been attributed to an overdose of collagenase in clinical trials. If required, the collagenase enzymes can be inactivated with a povidone-iodine wash. |
|---|
- No clinical adverse reactions have been reported from overdose of collagenase in clinical studies
- Collagenase enzymatic activity can be neutralized using a povidone-iodine solution if necessary
- Handle with appropriate protective measures to avoid unintended tissue exposure due to its proteolytic activity
Collagenase clostridium histolyticum is a type of Enzyme Replacements/modifiers
Enzyme replacements/modifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various enzyme-related disorders. Enzymes play a vital role in the normal functioning of the body by catalyzing specific biochemical reactions. However, in certain medical conditions, the body may lack or produce dysfunctional enzymes, leading to serious health complications.
Enzyme replacement therapy (ERT) involves administering exogenous enzymes to compensate for the enzyme deficiency in patients. These enzymes are typically derived from natural sources or produced using recombinant DNA technology. By introducing these enzymes into the body, they can effectively substitute the missing or defective enzymes, thereby restoring normal metabolic processes.
On the other hand, enzyme modifiers are API substances that regulate the activity of specific enzymes within the body. These modifiers can either enhance or inhibit the enzyme's function, depending on the therapeutic objective. By modulating enzyme activity, these APIs can restore the balance of enzymatic reactions, leading to improved physiological outcomes.
Enzyme replacements/modifiers have shown remarkable success in treating various genetic disorders, such as Gaucher disease, Fabry disease, and lysosomal storage disorders. Additionally, they have demonstrated potential in managing enzyme deficiencies associated with rare diseases and certain types of cancer.
The development and production of enzyme replacements/modifiers involve rigorous research, formulation optimization, and adherence to stringent quality control measures. Pharmaceutical companies invest substantial resources in developing these APIs to ensure their safety, efficacy, and compliance with regulatory standards.
Overall, enzyme replacements/modifiers represent a vital therapeutic category in modern medicine, offering hope and improved quality of life for patients with enzyme-related disorders.
Collagenase clostridium histolyticum API manufacturers & distributors
Compare qualified Collagenase clostridium histolyticum API suppliers worldwide. We currently have 1 companies offering Collagenase clostridium histolyticum API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA | 757 products |
When sending a request, specify which Collagenase clostridium histolyticum API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Collagenase clostridium histolyticum API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
