Ferric citrate anhydrous
As of the edition of 20 October 2026, Ferric citrate anhydrous is a small molecule: marketed, first approved in 2014 (JP).
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
- Auryxia
- First approved
- 17 January 2014 (JP)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Averoa; 3 holders in all
- Withdrawn from market
- 13 January 2020 (in some regions)
- Registered trials
- 24, 2 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Nutrition and metabolism; Blood and lymph; Hormones
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 | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 11 | 8 | 1 | 1 |
| Phase 4 | 6 | 4 | 1 | 1 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Akebia Therapeutics | Applicant and Lead sponsor of trials | 2008 to now |
| Japan Tobacco | Applicant | 2014 to now |
| Averoa | Applicant | 2025 to now |