Sodium citrate
As of the edition of 20 October 2026, Sodium citrate is a small molecule: marketed, first approved in 1980 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Isolyte E W/ Dextrose 5% In Plastic Container
- First approved
- 31 December 1980 (CA)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Clinigen; 5 holders in all
- Registered trials
- 13, 2 stopped early
- Disease areas
- Lungs and airways; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Bones, joints and muscles; Digestive 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 | 3 | 2 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 3 | 0 | 0 | 0 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alcon | Applicant | 1980 to now |
| Baxter Healthcare | Later holder | 1990 to now |
| Johnson & Johnson | Later holder | 1994 to now |
| Clinigen | Applicant | 2025 to now |