Etodolac
As of the edition of 20 October 2026, Etodolac is a small molecule: marketed, first approved in 1986 (FR); acts on PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Lodine
- First approved
- 25 April 1986 (FR)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Apsen Farmaceutica; 4 holders in all
- Registered trials
- 14, 1 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Hormones; Inherited and neonatal; Nutrition and metabolism; Pregnancy and women's health
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 Etodolac.
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 |
|---|---|---|
| PTGS2 | Prostaglandin G/H synthase 2 | P35354 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 3 | 0 | 1 | 1 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant | 1991 to now |
| Apsen Farmaceutica | Applicant | 1998 to now |