Formoterol
As of the edition of 20 October 2026, Formoterol is a small molecule: marketed, first approved in 1994 (FR); acts on ADRB2.
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
- Foradil
- First approved
- 22 July 1994 (FR)
- Approvals on record
- 45 in 6 regions
- Holder of the most recent approval
- Chiesi Farmaceutici; 12 holders in all
- Withdrawn from market
- 6 March 2025 (in some regions)
- Registered trials
- 212, 12 stopped early
- Disease areas
- Lungs and airways; Immune system; Infections; Hormones; Nutrition and metabolism; Cancer
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Formoterol.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 33 | 19 | 9 | 1 |
| Phase 1 | 14 | 14 | 0 | 0 |
| Phase 2 | 36 | 31 | 3 | 1 |
| Phase 3 | 81 | 67 | 6 | 2 |
| Phase 4 | 48 | 29 | 3 | 8 |
| All trials | 212 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 1998 to now |
| Novartis | Applicant and Lead sponsor of trials | 2001 to now |
| Chiesi Farmaceutici | Later holder and Lead sponsor of trials | 2005 to now |
| Viatris | Acquired holder, Later holder and Lead sponsor of trials | 2006 to now |
| Teva | Applicant and Lead sponsor of trials | 2014 to now |
| Covis Pharma | Later holder | 2014 to now |
| Kyorin Pharmaceutical | Applicant |