AZD1981 Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials evaluating the CRTh2 receptor antagonist AZD1981 have reached completed recruitment status, sponsored primarily by AstraZeneca with academic collaboration from Johns Hopkins University. These studies assessed pharmacokinetic, pharmacodynamic, safety, and therapeutic efficacy outcomes across inflammatory and metabolic conditions, including type 2 diabetes mellitus, chronic idiopathic urticaria, and asthma, with specific evaluations conducted in adolescent cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02367066	Completed	Type 2 Diabetes Mellitus	AstraZeneca	2015-03	Phase 1
NCT02031679	Completed	Chronic Idiopathic Urticaria	Johns Hopkins University\|AstraZeneca	2014-01	Phase 2
NCT01199341	Completed	Pharmakokinetic	AstraZeneca	2010-10	Phase 1
NCT01196689	Completed	Asthma	AstraZeneca	2010-10	Phase 1

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

Check the AZD1981 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD1981 functions as a potent and selective antagonist of the CRTh2 (DP2) receptor, potently inhibiting prostaglandin D2-mediated activation and intracellular signaling downstream of this receptor. By suppressing CRTh2 activation, AZD1981 prevents the chemotaxis and activation of pro-inflammatory effector cells such as Th2 lymphocytes, eosinophils, and basophils, providing the mechanistic foundation for its clinical evaluation in inflammatory disorders including asthma and chronic idiopathic urticaria.

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>).