Phytonadione
As of the edition of 20 October 2026, Phytonadione is a small molecule: marketed, first approved in 1954 (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
- Aquamephyton
- First approved
- 1 June 1954 (ES)
- Approvals on record
- 11 in 4 regions
- Holder of the most recent approval
- B. Braun Medical; 8 holders in all
- Registered trials
- 15, 1 stopped early
- Disease areas
- Nutrition and metabolism; Blood and lymph; Heart and blood vessels; Cancer; Urinary and reproductive; Bones, joints and muscles
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 | 3 | 0 | 0 |
| Phase 1 | 5 | 4 | 0 | 0 |
| Phase 2 | 3 | 1 | 2 | 0 |
| Phase 3 | 3 | 1 | 1 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder | 2019 to now |
| Pharmaceutical Associates | Acquired holder | 2022 to now |
| B. Braun Medical | Applicant | 2024 to now |
| Merck & Co. | Later holder | |
| Roche | Later holder |