Eflornithine
As of the edition of 20 October 2026, Eflornithine is a small molecule: marketed, first approved in 1990 (US); acts on ODC1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- Ornidyl
- First approved
- 28 November 1990 (US)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Uswm; 5 holders in all
- Registered trials
- 41, 3 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Urinary and reproductive; Infections; Inherited and neonatal
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Uswm holds a later exclusivity on its own new formulation or combination product, ending 2030; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Eflornithine.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ODC1 | Ornithine decarboxylase | P11926 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 5 | 3 | 2 | 0 |
| Phase 2 | 22 | 11 | 10 | 1 |
| Phase 3 | 9 | 5 | 1 | 2 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant | 1990 to now |
| Almirall | Applicant | 2001 to now |
| Cipher Pharmaceuticals | Applicant | 2001 to now |
| AbbVie | Acquired holder and Lead sponsor of trials | 2004 to now |
| Uswm | Later holder | 2023 to now |