Naloxegol
As of the edition of 20 October 2026, Naloxegol is a small molecule: marketed, first approved in 2014 (US); acts on OPRM1; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Movantik
- First approved
- 16 September 2014 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Grunenthal; 2 holders in all
- Registered trials
- 35, 7 stopped early
- Disease areas
- Chemically induced; Mental health; Digestive system; Pregnancy and women's health; Urinary and reproductive; Cancer
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Averitas Pharma.
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Naloxegol.
See the 3 companies 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 | 6 | 3 | 1 | 1 |
| Phase 1 | 12 | 12 | 0 | 0 |
| Phase 2 | 4 | 1 | 0 | 2 |
| Phase 3 | 9 | 5 | 0 | 2 |
| Phase 4 | 4 | 2 | 0 | 2 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator and Lead sponsor of trials | 2007 to now |
| Grunenthal | Applicant | 2014 to now |
| Averitas Pharma | Acquired holder | 2025 to now |