Tranexamic acid
As of the edition of 20 October 2026, Tranexamic acid is a small molecule: marketed, first approved in 1980 (ES); acts on PLG.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Cyklokapron
- First approved
- 1 January 1980 (ES)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- ZYDUS NIKKHO FARMACĂUTICA LTDA; 8 holders in all
- Registered trials
- 457, 57 stopped early
- Disease areas
- Urinary and reproductive; Pregnancy and women's health; Injuries; Bones, joints and muscles; Cancer; Heart and blood vessels
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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Tranexamic acid.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PLG | Plasminogen [Cleaved into: Plasmin | P00747 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 126 | 70 | 18 | 5 |
| Phase 1 | 23 | 10 | 7 | 2 |
| Phase 2 | 54 | 23 | 13 | 13 |
| Phase 3 | 117 | 53 | 26 | 13 |
| Phase 4 | 137 | 64 | 24 | 24 |
| All trials | 457 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1986 to now |
| Xanodyne Pharmaceutics | Later holder | 2009 to now |
| Exela Pharma Sciences | Later holder and Lead sponsor of trials | 2018 to now |
| Baxter Healthcare | Applicant | 2020 to now |
| J Molner | Acquired holder | 2026 to now |