Montelukast
As of the edition of 20 October 2026, Montelukast is a small molecule: marketed, first approved in 1998 (US); acts on CYSLTR1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Singulair
- First approved
- 20 February 1998 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Organon; 4 holders in all
- Registered trials
- 206, 12 stopped early
- Disease areas
- Lungs and airways; Immune system; Ear, nose and throat; Infections; Urinary and reproductive; Heart and blood vessels
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Montelukast.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CYSLTR1 | Cysteinyl leukotriene receptor 1 | Q9Y271 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 28 | 19 | 1 | 2 |
| Phase 1 | 39 | 35 | 4 | 0 |
| Phase 2 | 34 | 19 | 8 | 3 |
| Phase 3 | 57 | 45 | 3 | 5 |
| Phase 4 | 48 | 35 | 4 | 2 |
| All trials | 206 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 1995 to now |
| Merck & Co. | Originator and Lead sponsor of trials | 1998 to now |