Collagenase clostridium histolyticum

Generic Name: Collagenase clostridium histolyticum

Brand Names: Qwo, Santyl, Xiaflex

Drug Type: Biotech

CAS Number: 9001-12-1

Unique Ingredient Identifier: 9X7O8V25IT

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. The topical formulation is used for the debridement of necrotic tissue due to burns or chronic ulcers.

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

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. Collagenase ointment is used for the tissue debridement of chronic dermal ulcers and severely burned tissues.

The combination collagenase product, also known as Qwo, is used for the treatment of moderate to severe cellulite in the buttocks of adult women.

Associated Conditions: Dupuytren's Contracture of the Hand (Viking's Disease), Peyronie's Disease, Necrotic tissue

Clinical Trials

Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease

Phase 4

Recruiting

Conditions: Peyronie Disease

Interventions: Drug: Collagenase Clostridium Histolyticum
Device: RestoreX
Drug: Sildenafil

First Posted Date: 2024-10-18

Last Posted Date: 2025-02-13

Lead Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

Target Recruit Count: 40

Registration Number: NCT06649539

Locations: 🇺🇸
Male Fertility and Peyronie's Clinic, Orem, Utah, United States

A Study to Assess EN3835 in the Treatment of Plantar Fasciitis (PFA)

Phase 2

Completed

Conditions: Plantar Fasciitis

Interventions: Biological: EN3835
Other: Placebo

First Posted Date: 2023-12-13

Last Posted Date: 2024-10-28

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 231

Registration Number: NCT06169319

Locations: 🇺🇸
Endo Site 23, Stonecrest, Georgia, United States
🇺🇸
Endo Site 35, Shreveport, Louisiana, United States
🇺🇸
Endo Site 19, Grand Rapids, Michigan, United States

and more 36 locations

Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)

Phase 3

Recruiting

Conditions: Plantar Fibromatosis
Ledderhose Disease

Interventions: Other: Placebo
Biological: EN3835

First Posted Date: 2023-11-30

Last Posted Date: 2025-03-05

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 418

Registration Number: NCT06151197

Locations: 🇺🇸
Endo Site 42, Mesa, Arizona, United States
🇺🇸
Endo Site 64, Scottsdale, Arizona, United States
🇺🇸
Endo Site 11, Tucson, Arizona, United States

and more 67 locations

Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease

Not Applicable

Recruiting

Conditions: Peyronie Disease
Erectile Dysfunction

Interventions: Drug: Collagenase Clostridium Histolyticum
Device: Storz Duolith LiSWT

First Posted Date: 2023-10-04

Last Posted Date: 2025-04-24

Lead Sponsor: Mayo Clinic

Target Recruit Count: 60

Registration Number: NCT06065436

Locations: 🇺🇸
Mayo Clinic Minnesota, Rochester, Minnesota, United States

Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Phase 4

Recruiting

Conditions: Genital Diseases, Male
Sexual Dysfunctions, Psychological
Peyronie Disease

Interventions: Drug: Collagenase Clostridium Histolyticum (CCH)

First Posted Date: 2023-03-20

Last Posted Date: 2025-01-24

Lead Sponsor: University of Miami

Target Recruit Count: 22

Registration Number: NCT05777031

Locations: 🇺🇸
University of Miami - Desai Sethi Urology Institute, Miami, Florida, United States
🇺🇸
University of Miami, Miami, Florida, United States

Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction

Not Applicable

Withdrawn

Conditions: Erectile Dysfunction
Penile Curvature
Peyronie Disease

Interventions: Device: Duolith SD1 T-TOP
Drug: Collagenase Clostridium Histolyticum

First Posted Date: 2022-12-12

Last Posted Date: 2023-10-10

Lead Sponsor: Mayo Clinic

Registration Number: NCT05646602

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females

Phase 4

Completed

Conditions: Cellulite

Interventions: Drug: Collagenase Clostridium Histolyticum-Aaes
Drug: Lysteda 650 MG Oral Tablet

First Posted Date: 2022-04-04

Last Posted Date: 2023-03-08

Lead Sponsor: Luxurgery

Target Recruit Count: 17

Registration Number: NCT05309525

Locations: 🇺🇸
Luxurgery, New York, New York, United States

Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis

Phase 3

Completed

Conditions: Plantar Fibromatosis

Interventions: Biological: EN3835

First Posted Date: 2022-02-24

Last Posted Date: 2025-03-25

Lead Sponsor: Endo Pharmaceuticals

Target Recruit Count: 145

Registration Number: NCT05254457

Locations: 🇺🇸
Endo Clinical Trial Site #12, Bakersfield, California, United States
🇺🇸
Endo Clinical Trial Site #3, Fresno, California, United States
🇺🇸
Endo Clinical Trial Site #23, La Mesa, California, United States

and more 24 locations