Collagenase clostridium histolyticum
As of the edition of 20 October 2026, Collagenase clostridium histolyticum is an enzyme: marketed, first approved in 1965 (US); US protection ended in 1977.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Enzyme
- Brand name
- Santyl
- First approved
- 4 June 1965 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Endo Global Aesthetics; 4 holders in all
- Registered trials
- 61, 5 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; Cancer; Urinary and reproductive; Hormones; Heart and blood vessels
US protection
US protection ended in 1977.
US protection ended in 1977, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
Auxilium Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, which ended in 2020; it does not protect the original drug.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 3 | 1 | 2 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 19 | 16 | 0 | 1 |
| Phase 3 | 15 | 14 | 0 | 0 |
| Phase 4 | 14 | 7 | 4 | 2 |
| All trials | 61 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Smith & Nephew | Applicant and Lead sponsor of trials | 1965 to now |
| Auxilium Pharmaceuticals | Later holder | 2010 to now |
| Asahi Kasei Therapeutics | Applicant and Lead sponsor of trials | 2012 to now |
| Endo Global Aesthetics | Later holder | 2020 to now |