Clindamycin
As of the edition of 20 October 2026, Clindamycin is a small molecule: marketed, first approved in 1970 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Cleocin Hydrochloride
- First approved
- 1 December 1970 (ES)
- Approvals on record
- 52 in 6 regions
- Holder of the most recent approval
- Bausch Health; 11 holders in all
- Registered trials
- 81, 6 stopped early
- Disease areas
- Infections; Skin and connective tissue; Urinary and reproductive; Lungs and airways; Pregnancy and women's health; Cancer
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 9 | 2 | 3 |
| Phase 1 | 10 | 8 | 1 | 0 |
| Phase 2 | 15 | 9 | 3 | 1 |
| Phase 3 | 16 | 12 | 2 | 0 |
| Phase 4 | 22 | 12 | 8 | 2 |
| All trials | 81 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1970 to now |
| Astellas | Later holder | 1989 to now |
| Baxter Healthcare | Later holder | 1989 to now |
| Kv Pharmaceutical | Later holder | 2004 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| GSK | Later holder and Lead sponsor of trials | 2008 to now |
| Padagis | Acquired holder and Lead sponsor of trials | 2015 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Organon | Acquired holder | 2024 to now |
| Quagen Pharmaceuticals | Acquired holder | 2026 to now |