Caffeine
As of the edition of 20 October 2026, Caffeine is a small molecule: marketed, first approved in 1927 (ES); acts on ADORA1, ADORA2A and ADORA2B and 1 more.
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
- Cafergot
- First approved
- 1 January 1927 (ES)
- Approvals on record
- 25 in 6 regions
- Holder of the most recent approval
- Gennisium Pharma; 15 holders in all
- Registered trials
- 295, 18 stopped early
- Disease areas
- Nervous system; Lungs and airways; Mental health; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism
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 Caffeine.
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 | 134 | 93 | 17 | 8 |
| Phase 1 | 94 | 80 | 7 | 3 |
| Phase 2 | 17 | 8 | 6 | 1 |
| Phase 3 | 29 | 17 | 5 | 4 |
| Phase 4 | 21 | 12 | 4 | 2 |
| All trials | 295 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Aralez Pharmaceuticals | Applicant | 1970 to now |
| Bayer | Later holder and Lead sponsor of trials | 2005 to now |
| Chiesi Farmaceutici | Applicant | 2009 to now |
| Nobelpharma | Applicant and Lead sponsor of trials | 2011 to now |
| Gennisium Pharma | Later holder | 2020 to now |
| Hikma Pharmaceuticals | Acquired holder | 2021 to now |