Gefitinib-based PROTAC 3 Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

Several clinical trials, all currently designated as not yet recruiting, are associated with this compound across a range of conditions, including advanced or recurrent uterine corpus carcinoma, pediatric sleep intervention, Alzheimer's disease, alcohol use experiences, and chronic pain management. While gynecologic oncology trials are among these investigations, non-oncology protocols list their phase designations as unassigned or not applicable. Primary sponsors across the trial landscape include academic centers, federal institutes, and international research organizations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01164735	Not yet recruiting	Recurrent Uterine Corpus Carcinoma\|Stage III Uterine Corpus Cancer\|Stage IV Uterine Corpus Cancer	Gynecologic Oncology Group\|National Cancer Institute (NCI)\|GOG Foundation	2100-01	--
NCT05763030	Not yet recruiting	Child Sleep	New York State Psychiatric Institute\|International Centre for Diarrhoeal Disease Research Bangladesh\|Fogarty International Center of the National Institute of Health	2027-04	Not Applicable
NCT02438202	Not yet recruiting	Alzheimer''s Disease	Central Institute of Mental Health Mannheim	2026-12	Not Applicable
NCT06392542	Not yet recruiting	Alcohol Use Unspecified\|Relationship Social\|Depression Anxiety\|Transgenderism	Boston University\|National Institute on Alcohol Abuse and Alcoholism (NIAAA)	2026-04	Not Applicable
NCT06077526	Not yet recruiting	Chronic Pain	Bridgewater College	2026-01-13	Not Applicable

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

Check the Gefitinib-based PROTAC 3 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gefitinib-based PROTAC 3 selectively bridges the epidermal growth factor receptor to the von Hippel-Lindau E3 ubiquitin ligase, inducing rapid polyubiquitination and proteasomal degradation of both wild-type and mutant receptor variants. This targeted receptor depletion halts downstream oncogenic signaling pathways and suppresses cell proliferation, providing therapeutic relevance for targeted intervention in oncological indications such as advanced uterine corpus carcinoma.

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>).