Ceftriaxone
As of the edition of 20 October 2026, Ceftriaxone is a small molecule: marketed, first approved in 1982 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Rocephin
- First approved
- 27 May 1982 (CH)
- Approvals on record
- 17 in 5 regions
- Holder of the most recent approval
- Baxter Healthcare; 6 holders in all
- Registered trials
- 85, 11 stopped early
- Disease areas
- Infections; Lungs and airways; Urinary and reproductive; Digestive system; Pregnancy and women's health; Nervous system
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 | 19 | 9 | 5 | 0 |
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 18 | 9 | 1 | 5 |
| Phase 3 | 20 | 11 | 3 | 1 |
| Phase 4 | 24 | 12 | 2 | 5 |
| All trials | 85 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Later holder | 1982 to now |
| B. Braun Medical | Later holder | 2005 to now |
| Baxter Healthcare | Applicant and Lead sponsor of trials | 2007 to now |