Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials have evaluated zafirlukast across oncology, allergy, and pharmacokinetic indications, including breast cancer-related capsular contracture, cat allergy-induced rhinitis, relapsed ovarian cancer, and bioequivalence in healthy subjects. Sponsored by academic institutions, medical centers, and pharmaceutical companies—such as Beth Israel Deaconess Medical Center, the University of California San Francisco, and Dr. Reddy's Laboratories—these studies range in recruitment status from completed and terminated to not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06069063 NOT_YET_RECRUITING
Allergy to Cats
Allergy & Asthma Medical Group & Research Center
 2025-12-05 PHASE2
NCT04339140 COMPLETED
Ovarian Cancer
Beth Israel Deaconess Medical Center
 2020-06-24 PHASE2
NCT02950480 TERMINATED
Breast Cancer
University of California, San Francisco
 2017-03-13 PHASE2
NCT02950480 Terminated
Breast Cancer
University of California San Francisco
 2017-03-13 Phase 2
NCT01283061 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2007-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-22)

Check the Zafirlukast product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zafirlukast functions as a selective cysteinyl leukotriene receptor antagonist, blocking leukotriene D4-mediated downstream signaling to attenuate inflammatory cell infiltration, vascular permeability, and smooth muscle contraction. By suppressing these leukotriene-driven inflammatory and tissue remodeling pathways, the compound alleviates bronchoconstriction and exhibits therapeutic relevance in clinical investigations for allergic conditions as well as malignancies such as breast and ovarian cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.