Clindamycin phosphate
As of the edition of 20 October 2026, Clindamycin phosphate is a small molecule: marketed, first approved in 1982 (US); no US protection of its own is listed.
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 T
- First approved
- 1 January 1982 (US)
- Approvals on record
- 40 in 3 regions
- Holder of the most recent approval
- Bausch Health; 11 holders in all
- Registered trials
- 22, 1 stopped early
- Disease areas
- Skin and connective tissue; Infections; Pregnancy and women's health; Urinary and reproductive; Cancer; Blood and lymph
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Organon holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 4 | 2 | 1 | 1 |
| Phase 3 | 8 | 8 | 0 | 0 |
| Phase 4 | 5 | 4 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| 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 | Applicant and Lead sponsor of trials | 2006 to now |
| Padagis | Acquired holder and Lead sponsor of trials | 2012 to now |
| Bausch Health | Acquired holder and Lead sponsor of trials | 2019 to now |
| Organon | Acquired holder | 2024 to now |
| Quagen Pharmaceuticals | Acquired holder | 2026 to now |
| Pfizer | Applicant |