Aspirin
As of the edition of 20 October 2026, Aspirin is a small molecule: marketed, first approved in 1922 (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 2014
- Kind
- Small molecule
- Brand name
- Darvon-N W/ Asa
- First approved
- 1 July 1922 (ES)
- Approvals on record
- 57 in 7 regions
- Holder of the most recent approval
- PLx Pharma; 23 holders in all
- Withdrawn from market
- 3 June 2016 (in some regions)
- Registered trials
- 770, 76 stopped early
- Disease areas
- Heart and blood vessels; Nervous system; Cancer; Urinary and reproductive; Pregnancy and women's health; 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
8 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product8 company-target rows are on route B because of Aspirin.
See the 8 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 | 177 | 78 | 30 | 15 |
| Phase 1 | 105 | 75 | 12 | 9 |
| Phase 2 | 124 | 72 | 19 | 15 |
| Phase 3 | 167 | 77 | 35 | 22 |
| Phase 4 | 197 | 99 | 36 | 15 |
| All trials | 770 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Applicant and Lead sponsor of trials | 1936 to now |
| Aralez Pharmaceuticals | Applicant | 1970 to now |
| Takeda | Applicant and Lead sponsor of trials | 2003 to now |
| PLx Pharma | Later holder and Lead sponsor of trials | 2008 to now |
| Sanofi | Applicant, Later holder and Lead sponsor of trials | 2008 to now |
| New Haven Pharmaceuticals | Later holder and Lead sponsor of trials | 2015 to now |
| Hesp | Acquired holder | 2023 to now |