Folic acid
As of the edition of 20 October 2026, Folic acid is a small molecule: marketed, first approved in 1948 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Folvite
- First approved
- 1 October 1948 (ES)
- Approvals on record
- 34 in 5 regions
- Holder of the most recent approval
- Solubiomix; 18 holders in all
- Registered trials
- 206, 20 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Immune system; Bones, joints and muscles; Skin and connective tissue; Pregnancy and women's health
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 | 31 | 20 | 3 | 2 |
| Phase 1 | 31 | 24 | 2 | 1 |
| Phase 2 | 65 | 38 | 6 | 10 |
| Phase 3 | 47 | 33 | 3 | 2 |
| Phase 4 | 32 | 19 | 3 | 5 |
| All trials | 206 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 1984 to now |
| CSL Behring | Later holder | 1985 to now |
| Baxter Healthcare | Later holder | 1987 to now |
| Eli Lilly | Later holder and Lead sponsor of trials | 2008 to now |
| B. Braun Medical | Later holder | 2024 to now |
| Cmp | Later holder | 2026 to now |
| Solubiomix | Acquired holder | 2026 to now |
| Pfizer | Applicant and Earlier holder |