Collagenase is an enzyme that breaks down collagen and is the only protease that can hydrolyze the triple helical region of collagen under physiological conditions.

Endogenous collagenase production is an essential biological mechanism that regulates matrix remodeling and encourages normal turnover of tissue as well as the removal of dead tissue. Once the collagen is cleaved into smaller units, the endogenous enzymes further assist in breaking down the fibrous material. Because collagenase does not damage the cell membrane, it has been widely used for cell dispersion for tissue disassociation and cell culture for many years.

The Clostridial collagenase produced by BioSpecifics has a broad specificity towards all types of collagen. It is acknowledged to be much more efficient than mammalian collagenases as Clostridial collagenase cleaves the collagen molecule at multiple sites along the triple helix, whereas the mammalian collagenase is only able to cleave the molecule at a single site along the triple helix.

Collagenase Development History

  • Early Period
  • Middle Period
  • Late Period

1916

1916
Proteolytic properties of Cl. histoyticum described by Weinberg and Seguin.

1937

1937
Maschmann coins term "collagenase."

1949

1949
Mandl and MacLennan purify/characterize collagenase from Cl. histolyticum.

1957

1957
Advance Biofactures Corp, formed to develop collagenase for debridement of chronic wounds and severe burns.

1965

1965
Collagenase ointment is approved and licensed for sale by Advance Biofactures in U.S. for debridement of chronic wounds and severe burns.

1972

1972
Knoll AG and Knoll Pharmaceutical Co. sign marketing agreement for sales of collagenase ointment in Europe and U.S.

1980s

1980s
Injectable collagenase is used in clinical trials for treatment of herniated disc disease as an adjunct to vitrectomy, keloids, hypertropic scars, and Peyronie's disease.

1990s

1990s
Injectable collagenase is used in clinical trials for treatment of Dupuytren's disease.

2004.1

2004
Auxilium signs Marketing and Development Agreement with BioSpecifics.

2005

2005
Auxilium reviews clinical trial results from BioSpecifics and agrees to develop Frozen Shoulder as an additional clinical indication.

2010

2010
XIAFLEX® approved by U.S. FDA in February for treatment of Dupuytren's contracture in adults with palpable cord in the palm.

2011

2011
BioSpecifics announces approval of XIAPEX® for treatment of Dupuytren's contracture in Europe.

2013

2013
XIAFLEX® approved by U.S. FDA in December 2013 for the treatment of Peyronie's disease in men with a palpable plaque and a curvature of 30 degrees or greater at the start of therapy.

2014

2014
XIAFLEX® label expands in October 2014 to include the concurrent treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit.

2015

2015
XIAPEX® label approved in Europe in January 2015 for the treatment of Peyronie's disease in men with a palable plaque and a curvature of 30 degrees or greater at the start of therapy.
2015
Asahi Kesai announces approval of XIAFLEX® for the treatment of Dupuytren's contracture in Japan.
2015
XIAPEX® approved in Europe in November 2015 for the concurrent treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit.