Mercaptopurine anhydrous
As of the edition of 20 October 2026, Mercaptopurine anhydrous is a small molecule: marketed, first approved in 1955 (CH); acts on PPAT.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Purinethol
- First approved
- 24 June 1955 (CH)
- Approvals on record
- 7 in 6 regions
- Holder of the most recent approval
- Nova; 7 holders in all
- Registered trials
- 192, 16 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections; Digestive system; Inherited and neonatal
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Mercaptopurine anhydrous.
See the 1 company 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 | 19 | 11 | 3 | 2 |
| Phase 1 | 10 | 6 | 4 | 0 |
| Phase 2 | 76 | 31 | 27 | 11 |
| Phase 3 | 67 | 38 | 14 | 3 |
| Phase 4 | 20 | 15 | 1 | 0 |
| All trials | 192 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lipomed | Applicant | 2012 to now |
| Nova | Later holder and Lead sponsor of trials | 2012 to now |
| Stason Pharmaceuticals | Acquired holder | 2016 to now |
| GSK | Earlier holder |