Ioflupane
As of the edition of 20 October 2026, Ioflupane is a small molecule: marketed, first approved in 2000 (EU); acts on SLC6A3.
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
- Datscan
- First approved
- 27 July 2000 (EU)
- Approvals on record
- 5 in 5 regions
- Holder of the most recent approval
- ROTOP RADIOPHARMACY (ALLEMAGNE); 4 holders in all
- Registered trials
- 14, 1 stopped early
- Disease areas
- Nervous system; Mental health; Eye; Cancer; Heart and blood vessels; Nutrition and metabolism
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 Ioflupane.
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 |
|---|---|---|
| SLC6A3 | Sodium-dependent dopamine transporter | Q01959 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 3 | 0 | 1 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GE Healthcare | Applicant | 2000 to now |
| GE Healthcare | Applicant and Lead sponsor of trials | 2001 to now |
| Nihon Medi-Physics | Applicant | 2013 to now |