Indacaterol
As of the edition of 20 October 2026, Indacaterol is a small molecule: marketed, first approved in 2009 (EU); acts on ADRB2.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Arcapta Neohaler
- First approved
- 29 November 2009 (EU)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Laboratorios Liconsa S.A.; 3 holders in all
- Registered trials
- 95, 5 stopped early
- Disease areas
- Lungs and airways; Immune system; Heart and blood vessels; 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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 2 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 21 | 20 | 0 | 1 |
| Phase 3 | 39 | 37 | 0 | 2 |
| Phase 4 | 23 | 19 | 0 | 2 |
| All trials | 95 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2004 to now |