Zafirlukast
As of the edition of 20 October 2026, Zafirlukast is a small molecule: marketed, first approved in 1996 (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 1996
- Kind
- Small molecule
- Brand name
- Accolate
- First approved
- 26 September 1996 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Strides Pharma
- Registered trials
- 4, 1 stopped early
- Disease areas
- Cancer; Hormones; Pregnancy and women's health; Skin and connective tissue; Urinary and reproductive
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.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CYSLTR1 | Cysteinyl leukotriene receptor 1 | Q9Y271 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 1 | 1 | 1 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Strides Pharma | Acquired holder | 2025 to now |
| AstraZeneca | Originator | 1996 to 2025 |