Nalfurafine
As of the edition of 20 October 2026, Nalfurafine is a small molecule: marketed, first approved in 2009 (JP); acts on OPRK1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Remitch
- First approved
- 21 January 2009 (JP)
- Approvals on record
- 4 in 1 region
- Holder of the most recent approval
- Toray Medical Co., Ltd.; 2 holders in all
- Registered trials
- 7, 0 stopped early
- Disease areas
- Skin and connective tissue
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 Nalfurafine.
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 |
|---|---|---|
| OPRK1 | Kappa-type opioid receptor | P41145 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 2 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 7 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Toray Industries | Applicant and Lead sponsor of trials | 2008 to now |