Daptomycin
As of the edition of 20 October 2026, Daptomycin is a small molecule: marketed, first approved in 2003 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Cubicin
- First approved
- 12 September 2003 (US)
- Approvals on record
- 23 in 4 regions
- Holder of the most recent approval
- Maia Pharmaceuticals; 6 holders in all
- Registered trials
- 75, 22 stopped early
- Disease areas
- Infections; Skin and connective tissue; Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Blood and lymph
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 14 | 6 | 0 | 2 |
| Phase 1 | 10 | 9 | 0 | 1 |
| Phase 2 | 13 | 8 | 0 | 2 |
| Phase 3 | 16 | 11 | 0 | 5 |
| Phase 4 | 22 | 8 | 1 | 12 |
| All trials | 75 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Acquired holder and Lead sponsor of trials | 2000 to now |
| Nichi-Iko Pharmaceutical | Later holder | 2017 to now |
| Pfizer | Later holder | 2021 to now |
| Baxter Healthcare | Later holder | 2022 to now |
| Maia Pharmaceuticals | Later holder | 2024 to now |
| Hikma Pharmaceuticals | Acquired holder | 2025 to now |