Azathioprine
As of the edition of 20 October 2026, Azathioprine is a small molecule: marketed, first approved in 1965 (CH); acts on PPAT.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Imuran
- First approved
- 15 November 1965 (CH)
- Approvals on record
- 13 in 7 regions
- Holder of the most recent approval
- Lipomed; 11 holders in all
- Registered trials
- 87, 16 stopped early
- Disease areas
- Immune system; Digestive system; Skin and connective tissue; Heart and blood vessels; Nervous system; Lungs and airways
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 Azathioprine.
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 |
|---|---|---|
| PPAT | Amidophosphoribosyltransferase | Q06203 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 8 | 6 | 2 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 14 | 8 | 5 | 1 |
| Phase 3 | 26 | 10 | 4 | 8 |
| Phase 4 | 20 | 8 | 3 | 5 |
| All trials | 87 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Later holder and Lead sponsor of trials | 2002 to now |
| Casper Pharma | Acquired holder | 2017 to now |
| Lipomed | Applicant | 2021 to now |
| Legacy Pharma Inc Sezc | Acquired holder | 2026 to now |
| Mitsubishi Tanabe Pharma | Applicant |