Naldemedine
As of the edition of 20 October 2026, Naldemedine is a small molecule: marketed, first approved in 2017 (US); acts on OPRM1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Symproic
- First approved
- 23 March 2017 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Shionogi; 3 holders in all
- Registered trials
- 8, 1 stopped early
- Disease areas
- Chemically induced; Mental health
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Collegium Pharmaceutical.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
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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 Naldemedine.
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 |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 2 | 4 | 2 | 1 | 1 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shionogi | Originator, Applicant and Lead sponsor of trials | 2010 to now |
| Collegium Pharmaceutical | Acquired holder and Lead sponsor of trials | 2019 to now |