Drugs / Zafirlukast
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ACCOLATE | — | 1999-09-17 – 2001-04-27 | fda.gov ↗ |
| Approved | US (FDA) | ACCOLATE | — | 1996-09-26 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT06069063 | Dec 2025 → Jun 2026 overdue | — | Allergy & Asthma Medical Group & Research Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04339140 | Jun 2020 → Dec 2023 | ovarian cancer | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02950480 | Mar 2017 → Dec 2018 | breast cancer | University of California, San Francisco | Terminated | No outcome recorded Stop: Enrollment |
| Phase 31 trial | ||||||
| Phase 3 | NCT04871828 | Feb → Sep 2021 | — | King Abdullah International Medical Research Center | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT01125748 Background | May 2010 → Aug 2013 | allergic asthma | Genentech, Inc. | Completed | Met primary |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-07-26 | Invion, Inc. | Joint development and licensing agreement for Zafirlukast inviongroup.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zafirlukast | “Description of investigational drug Zafirlukast is leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma.” NCT04871828 ↗4“zafirlukast or other leukotriene receptor antagonist” NCT01125748 ↗ |
| Known as | Accolate | “It is approved by USFDA and currently commercially marketed under the name of Accolate 20 mg oral tablet.” NCT04871828 ↗ |
| Known as | ICI 204,219 | ChEMBL registry synonym — accepted as the source's own label CHEMBL603 ↗ |
| Action | Inhibit | “Cysteinyl leukotriene receptor 1 antagonist” CHEMBL603 ↗1“Leukotriene Inhibitor Zafirlukast” NCT02950480 ↗ |
| Modality | Small molecule | — CHEMBL603 ↗ |
| Route | Oral | “20mg PO BID” NCT02950480 ↗ |
| Target | CYSLTR1 | “Cysteinyl leukotriene receptor 1 antagonist” CHEMBL603 ↗ |