CLINICAL TRIALS PROFILE FOR COLLAGENASE

All Clinical Trials for collagenase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004409 ↗	Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease	Completed	State University of New York	Phase 2	1995-08-01	OBJECTIVES: Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.
NCT00014742 ↗	Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease	Completed	State University of New York	Phase 3	1969-12-31	OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity, range of finger motion, and grip strength in patients with residual stage Dupuytren's disease. II. Compare the overall clinical success rate, time to return to normal finger contracture to within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of patients treated with these regimens. III. Compare the baseline change in degree of finger flexion deformity, range of motion of the treated finger, and strength of hand grip (in pounds) in patients treated with these regimens. IV. Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal (zero degrees) and the number who require re-treatment with open-label collagenase after treatment with these regimens.
NCT00261144 ↗	Collagenase in the Treatment of Cellulite	Unknown status	Stony Brook University	Phase 2	2013-02-01	The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.
NCT00261196 ↗	Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)	Withdrawn	Biospecifics Technologies Corp.	Phase 2	2006-01-01	The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
NCT00261196 ↗	Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)	Withdrawn	Stony Brook University	Phase 2	2006-01-01	The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.
NCT00261209 ↗	Collagenase in the Treatment of Zone II Flexor Tendon Adhesions in the Hand	Completed	Stony Brook University	Phase 1/Phase 2	2005-01-01	The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.
NCT00294775 ↗	Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis	Unknown status	Odense University Hospital	Phase 3	2006-02-01	The consequence of aortic valve stenosis (AVS) is increased pressure load on the left ventricle which causes left ventricular (LV) hypertrophy, and myocardial stretch will cause activation of cardiac peptides and activation of the renin angiotensin aldosterone system (RAAS). The consequence of LV hypertrophy is increased chamber-stiffness and delayed active LV relaxation which initially will cause diastolic and later systolic dysfunction. In heart failure (HF) and ischemic heart disease the degree of diastolic dysfunction has been demonstrated to correlate with functional class, neurohormonal activation and prognosis which also recently have been suggested for AVS. With longstanding elevated filling pressures the left atrium (LA) will dilate. Only limited data are available on the degree and importance of LA dilatation in AVS. When apparent, symptoms of HF in AVS are associated with high mortality rates. If LV systolic dysfunction also is present prognosis will deteriorate further. In these cases aorta valve replacement (AVR) is recommended. AVR will normalize pressure overload and thereby decreases LV hypertrophy. Previously it was believed that in time LV hypertrophy regressed towards normal and even normalized. Recent studies however have demonstrated that LV hypertrophy regression mainly happens during the first year after AVR, and little subsequent changes are seen during the remaining 10 years. Furthermore, patients that experience most regression of hypertrophy have more favourable outcome and better functional class than patients with less regression of hypertrophy. Thus absence of reverse remodelling is associated with poor outcome after AVR. Importantly the regression of LV hypertrophy is closely paralleled by decreasing RAAS hyperactivity. RAAS hyperactivity may be attenuated pharmacologically with angiotensin II receptor blockers (ARB) which in systemic hypertension with LV hypertrophy has been associated with reverse remodelling. The hypothesis is that in patients undergoing AVR for symptomatic AVS, 12 months post operative blockade of the angiotensin II receptor will accelerate LV and LA reverse remodelling, reduce filling pressures and suppress neurohormonal activation compared with conventional therapy. This will lead to improved exercise tolerance and due to improved left atrial function reducing the risk of atrial arrythmias.

Clinical Trial Conditions for collagenase

Condition Name

Condition Name for collagenase
Intervention	Trials
Peyronie Disease	5
Cellulite	4
Dupuytren Contracture	4
Dupuytren's Contracture	4

Condition MeSH

Condition MeSH for collagenase
Intervention	Trials
Dupuytren Contracture	12
Contracture	10
Penile Induration	8
Cellulite	4

Clinical Trial Locations for collagenase

Trials by Country

Trials by Country for collagenase
Location	Trials
United States	75
Canada	10
Germany	6
Finland	6
Italy	4

Trials by US State

Trials by US State for collagenase
Location	Trials
New York	12
Florida	10
Pennsylvania	6
Utah	5
Texas	5

Clinical Trial Progress for collagenase

Clinical Trial Phase

Clinical Trial Phase for collagenase
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	4
PHASE1	1

Clinical Trial Status

Clinical Trial Status for collagenase
Clinical Trial Phase	Trials
Completed	27
Recruiting	14
Unknown status	7

Clinical Trial Sponsors for collagenase

Sponsor Name

Sponsor Name for collagenase
Sponsor	Trials
Endo Pharmaceuticals	9
Healthpoint	6
Charitable Union for the Research and Education of Peyronie's Disease	3

Sponsor Type

Sponsor Type for collagenase
Sponsor	Trials
Other	71
Industry	34
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Collagenase

Last updated: October 29, 2025

---

Introduction

Collagenase, a specialized enzyme that breaks down collagen, has garnered significant interest within the pharmaceutical and biotech sectors. Its applications span from treating connective tissue disorders to facilitating fat and skin reduction procedures, positioning it as a versatile therapeutic and cosmetic agent. As the landscape evolves, understanding recent clinical developments, market dynamics, and future projections becomes essential for stakeholders aiming to capitalize on growth opportunities and mitigate risks.

---

Clinical Trials Update

Recent Developments and Ongoing Studies

Over the past year, several key clinical trials have propelled collagenase into the spotlight. The most prominent among these are studies focused on indications such as Dupuytren’s contracture, Peyronie’s disease, and cellulite treatment.

• Dupuytren’s Contracture: The FDA-approved Collagenase Clostridium Histolyticum (CCH) franchise, notably Xiaflex, continues to be evaluated in post-market surveillance and real-world effectiveness studies. Ongoing Phase IV studies aim to monitor long-term safety and optimize injection protocols. For instance, recent data indicate sustained efficacy with minimal adverse events, reinforcing its role as a first-line treatment [1].

• Peyronie’s Disease: Multiple Phase III trials are examining collagenase’s efficacy in reducing penile curvature. Preliminary results demonstrate promising improvements, with corrected curves averaging 30-40% reduction [2].

• Cosmetic and Dermatological Applications: Experimental trials are investigating collagenase’s potential in cellulite reduction and scar management. Notably, a 2022 Phase II trial evaluated a topical formulation, showing moderate fat layer reduction with a favorable safety profile [3].

Emerging Formulations and Delivery Systems

Innovations in drug delivery—such as localized controlled-release injections and combination therapies—are under exploration. Biotech firms are developing recombinant collagenases with enhanced specificity and reduced immunogenicity, aiming to improve safety and efficacy profiles. For instance, a novel recombinant collagenase in Phase I trials shows promising stability and activity in preclinical studies.

Regulatory Landscape

The regulatory environment remains supportive, with agencies like the FDA approving Xiaflex for Dupuytren’s contracture and Peyronie’s disease. However, approval pathways for off-label cosmetic uses face significant hurdles, emphasizing the need for rigorous clinical data. Future approvals depend heavily on demonstrating safety and comparative effectiveness in new indications.

---

Market Analysis

Market Size and Growth Drivers

The global collagenase market was valued at approximately $200 million in 2022 and is projected to reach around $400 million by 2030, growing at a compound annual growth rate (CAGR) of 9-10% [4]. This growth is driven by several factors:

• Growing prevalence of connective tissue disorders: Conditions like Dupuytren’s contracture and Peyronie’s disease are increasingly diagnosed, expanding the patient base.
• Expansion into aesthetic medicine: The rising demand for minimally invasive procedures targeting cellulite, scars, and facial rejuvenation boosts market traction.
• Technological advances: Improved enzyme formulations and delivery mechanisms enhance treatment outcomes and patient acceptance.

Competitive Landscape

Major players include Endo Pharmaceuticals, Allergan (AbbVie), and emerging biotech firms specializing in enzyme engineering. Xiaflex remains the dominant product, holding over 70% of the market share in indications like Dupuytren’s contracture, supported by robust clinical data and broad insurance coverage.

New entrants focus on niche indications such as cellulite and scar modulation, often leveraging peptide engineering and novel delivery platforms to differentiate. Patents around recombinant collagenase variants provide a competitive edge, with some companies filing exclusivity claims extending into 2030.

Market Challenges and Opportunities

Challenges include:

• Regulatory hurdles for off-label and cosmetic indications.
• Immunogenicity concerns due to enzyme proteins eliciting immune responses.
• Limited reimbursement and high treatment costs hinder wider adoption.

Opportunities arise from:

• Developing combination therapies, such as collagenase with other enzymes or anti-inflammatory agents.
• Expanding into emerging markets, where aesthetic procedures are increasingly popular.
• Personalized medicine approaches, tailoring enzyme formulations to individual collagen profiles for optimized outcomes.

---

Market Projections

Forecasting Trends

Based on current growth trajectories and ongoing research, the collagenase market is expected to expand significantly over the next decade. Key projections include:

• Market Penetration in New Indications: Growth in non-FDA-approved uses such as cellulite and scar management could boost the market size by 20-30% annually in these segments.
• Recombinant Collagenase Adoption: The shift toward bioengineered enzymes is anticipated to reduce adverse events, leading to broader clinical acceptance.
• Geographic Expansion: Asia-Pacific and Latin America represent under-penetrated markets with increasing healthcare spending and aesthetic demand, potentially delivering 15-20% annual growth outside North America and Europe.

Scenario Analysis

• Optimistic Scenario: If additional indications gain regulatory approval and formulations improve safety profiles, market size could reach $600-$700 million by 2030.
• Conservative Scenario: Regulatory delays, reimbursement issues, or safety concerns could cap growth at $300-$350 million, emphasizing risk management.

---

Strategic Implications for Stakeholders

• Investors should monitor emerging clinical trial data and regulatory developments, particularly in cosmetic indications.
• Pharmaceutical companies may consider diversifying portfolios with recombinant formulations and exploring combination therapies.
• Clinicians and healthcare providers should stay updated on approval statuses and evolving treatment protocols to optimize patient outcomes.
• Regulatory agencies must balance innovation with safety, guiding responsible expansion into new domains.

---

Key Takeaways

• Clinical landscape: Collagenase continues to demonstrate effectiveness in approved uses like Dupuytren’s contracture and Peyronie’s disease, with expanding research into cosmetic applications.
• Market potential: The collagenase market is poised for near-double-digit CAGR growth, driven by technological advances, unmet needs, and expanding indications.
• Emerging trends: Recombinant collagenases and innovative delivery systems aim to mitigate limitations related to immunogenicity and administration.
• Challenges: Regulatory approval processes, high costs, and safety considerations require strategic navigation.
• Investment outlook: Stakeholders who monitor clinical trial pipelines, adapt to regulatory changes, and explore niche markets position themselves advantageously for growth.

---

FAQs

1. What are the primary approved uses of collagenase?
   Collagenase is primarily approved for treating Dupuytren’s contracture, Peyronie’s disease, and certain off-label uses such as fibrotic contractures. The FDA-approved formulation Xiaflex is extensively used in these indications.

2. Are there ongoing clinical trials for collagenase in aesthetic medicine?
   Yes. Multiple studies are investigating collagenase applications in cellulite reduction, scar remodeling, and facial rejuvenation. These studies are in phases II and III, with promising early results.

3. What are the main safety concerns associated with collagenase therapy?
   Potential adverse events include localized swelling, bruising, allergic reactions, and, rarely, tissue necrosis or systemic immune responses. Recombinant formulations aim to reduce immunogenicity and improve safety.

4. How does the market outlook vary between regions?
   North America and Europe dominate current markets due to advanced healthcare infrastructure and regulatory approvals. Emerging markets, such as Asia-Pacific, present high-growth opportunities owing to rising aesthetic consciousness and healthcare investments.

5. What is the future potential of recombinant collagenases?
   Recombinant enzymes promise improved safety, specificity, and stability, potentially enabling broader indications and patient acceptance. Their successful clinical development could significantly reshape the collagenase market landscape.

---

Conclusion

The collagenase market is on a trajectory of sustained growth, supported by ongoing clinical innovations and expanding therapeutic indications. Continued research, regulatory clarity, and technological advancements are essential to unlocking its full market potential. Stakeholders who strategically align with emerging trends and invest in next-generation formulations will be best positioned for success in this dynamic space.

---

Sources:

[1] FDA Drug Approvals and Post-market Surveillance Data.
[2] ClinicalTrials.gov, Peyronie’s Disease Studies (2022).
[3] Phase II Trial Data on Topical Collagenase for Cellulite Reduction.
[4] Market Research Future, Collagenase Market Analysis (2022).