Aceclofenac
As of the edition of 20 October 2026, Aceclofenac is a small molecule: marketed, first approved in 1991 (ES); acts on PTGS2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Small molecule
- Brand name
- Gerbin
- First approved
- 1 May 1991 (ES)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Eurofarma Laboratorios; 3 holders in all
- Registered trials
- 10, 1 stopped early
- Disease areas
- Bones, joints and muscles; Immune system; Mental health; Nervous system; 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGS2 | Prostaglandin G/H synthase 2 | P35354 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 4 | 2 | 0 | 1 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eurofarma Laboratorios | Applicant | 2002 to now |