Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 1/2, and Phase 2 have evaluated OC000459 for modulating eosinophilic inflammation in severe eosinophilic asthma, eosinophilic esophagitis, and allergic rhinitis, alongside safety assessments in healthy volunteers. Sponsored by commercial entities such as Oxagen Ltd and Chiesi Farmaceutici S.p.A. in collaboration with academic investigators at Imperial College London, all trials have completed recruitment.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02560610 Completed
Severe Eosinophilic Asthma
Chiesi Farmaceutici S.p.A.|Atopix Therapeutics Ltd.
 2016-09 Phase 2
NCT01056783 Completed
Eosinophilic Esophagitis
Oxagen Ltd
 2010-08 Phase 2
NCT01056575 Completed
Healthy Volunteers
Oxagen Ltd
 2010-02 Phase 1
NCT01448902 Completed
Allergic Rhinitis
Oxagen Ltd
 2007-03 Phase 2
NCT00290381 Completed
Allergic Rhinitis
Trevor Hansel|Oxagen Ltd|Imperial College London
 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the OC000459 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OC000459 functions as a potent and selective antagonist of the D prostanoid receptor 2 (DP2), effectively blocking prostaglandin D2-mediated intracellular signaling pathways and Th2 cytokine release. By inhibiting DP2 activation, the compound suppresses the activation and recruitment of eosinophils and lymphocytes, thereby reducing allergic mucosal inflammation in clinical indications such as severe eosinophilic asthma, eosinophilic esophagitis, and allergic rhinitis.

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.