3-Amino-9-ethylcarbazole Clinical Trials

Size	Price	Qty
100mg	USD 77

Clinical Trials

Several Phase II and Phase III clinical trials sponsored by academic and commercial entities, including AstraZeneca, Areteia Therapeutics, and the National Institute of Allergy and Infectious Diseases, are evaluating therapies for severe eosinophilic asthma, hypereosinophilic syndrome, and angioedema with eosinophilia. Multiple late-stage clinical trials are currently recruiting participants or enrolling by invitation for long-term extension assessments, although a clinical trial examining episodic angioedema was terminated. Together, these studies represent ongoing clinical research into eosinophilic inflammatory pathologies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06388889	Enrolling by invitation	Eosinophilic Asthma	Areteia Therapeutics	2024-05-08	Phase 3
NCT05813288	Recruiting	Eosinophilic Asthma\|Asthma; Eosinophilic\|Asthma	Areteia Therapeutics	2023-03-27	Phase 3
NCT05748600	Recruiting	Eosinophilic Asthma\|Asthma; Eosinophilic\|Asthma Attack	Areteia Therapeutics	2023-01-30	Phase 3
NCT05763121	Recruiting	Eosinophilic Asthma\|Asthma; Eosinophilic\|Asthma	Areteia Therapeutics	2023-01-30	Phase 3
NCT04128371	Terminated	Eosinophilia\|Angioedema	National Institute of Allergy and Infectious Diseases (NIAID)\|National Institutes of Health Clinical Center (CC)	2021-01-14	Phase 2
NCT04191304	Recruiting	Hypereosinophilic Syndrome	AstraZeneca	2020-07-20	Phase 3

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

Check the 3-Amino-9-ethylcarbazole product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

3-Amino-9-ethylcarbazole acts as a chromogenic donor substrate that undergoes localized oxidation by horseradish peroxidase in the presence of hydrogen peroxide, generating a red, water-insoluble end product. This enzymatic reaction enables precise immunohistochemical visualization of target biomarkers, facilitating the histological analysis of immune cell infiltration and tissue remodeling in clinical studies of eosinophilic asthma and hypereosinophilic syndrome.

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>).