Azelaic acid
As of the edition of 20 October 2026, Azelaic acid is a small molecule: marketed, first approved in 1989 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Azelex
- First approved
- 14 December 1989 (FR)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- LEO PHARMA LTDA; 6 holders in all
- Registered trials
- 25, 0 stopped early
- Disease areas
- Skin and connective tissue; Cancer
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 | 5 | 5 | 0 | 0 |
| Phase 1 | 4 | 2 | 2 | 0 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 6 | 6 | 0 | 0 |
| Phase 4 | 8 | 7 | 0 | 0 |
| All trials | 25 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| LEO Pharma | Applicant, Acquired holder and Lead sponsor of trials | 2002 to now |
| Bayer | Later holder | 2015 to now |
| Almirall | Acquired holder | 2019 to now |
| AbbVie | Originator | 1995 to 2019 |