Atropine
As of the edition of 20 October 2026, Atropine is a small molecule: marketed, first approved in 1957 (ES); acts on CHRM1, CHRM2 and CHRM3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Atropen
- First approved
- 1 April 1957 (ES)
- Approvals on record
- 32 in 7 regions
- Holder of the most recent approval
- Santen; 20 holders in all
- Registered trials
- 126, 8 stopped early
- Disease areas
- Eye; Nervous system; Heart and blood vessels; Cancer; Chemically induced; Immune 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
12 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product12 company-target rows are on route B because of Atropine.
See the 12 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 | 33 | 17 | 10 | 2 |
| Phase 1 | 19 | 12 | 2 | 2 |
| Phase 2 | 23 | 12 | 7 | 1 |
| Phase 3 | 23 | 13 | 5 | 3 |
| Phase 4 | 28 | 17 | 3 | 0 |
| All trials | 126 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Acquired holder | 1960 to now |
| Alcon | Later holder | 1964 to now |
| Thea Pharma | Applicant | 1987 to now |
| Bausch Health | Later holder | 1995 to now |
| Abbott | Later holder | 2001 to now |
| United States Army Office Surgeon General | Acquired holder | 2003 to now |
| Terumo | Applicant | 2008 to now |
| Akorn | Later holder | 2014 to now |
| Novartis | Later holder | 2016 to now |
| Fresenius Kabi | Later holder | 2018 to now |
| Rafa | Later holder | 2018 to now |
| Accord Healthcare | Later holder | 2020 to now |
| Rising Pharma | Acquired holder | 2023 to now |
| Santen Pharmaceutical | Later holder | 2024 to now |
| Santen | Applicant | 2025 to now |