Naproxen
As of the edition of 20 October 2026, Naproxen is a small molecule: marketed, first approved in 1977 (ES); acts on PTGS1 and PTGS2.
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
- Naprosyn
- First approved
- 1 July 1977 (ES)
- Approvals on record
- 33 in 5 regions
- Holder of the most recent approval
- Kenvue Brands; 14 holders in all
- Registered trials
- 154, 16 stopped early
- Disease areas
- Bones, joints and muscles; Nervous system; Mouth and teeth; Skin and connective tissue; Immune system; Digestive system
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 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Naproxen.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 12 | 4 | 1 |
| Phase 1 | 37 | 32 | 1 | 2 |
| Phase 2 | 22 | 14 | 2 | 5 |
| Phase 3 | 43 | 37 | 1 | 4 |
| Phase 4 | 34 | 24 | 3 | 4 |
| All trials | 154 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Later holder and Lead sponsor of trials | 1994 to now |
| Atnahs Pharma | Acquired holder | 2016 to now |
| Bionpharma | Acquired holder | 2016 to now |
| Twi Pharmaceuticals | Acquired holder | 2023 to now |