Encequidar (HM30181) Clinical Trials

Size	Price	Qty
5mg	USD 329
25mg	USD 987

Clinical Trials

Multiple clinical trials evaluate encequidar across Phase 1 through Phase 3 development, primarily focusing on solid tumors and various breast neoplasms, including metastatic and triple-negative breast cancer. Sponsored by industry and research organizations such as Athenex, Health Hope Pharma, Hanmi Pharmaceutical Company, and QuantumLeap Healthcare Collaborative, these studies range from completed and actively recruiting to terminated, unknown, and pending statuses. Key clinical objectives include assessing the safety, pharmacokinetics, food-effect bioavailability, and therapeutic activity of encequidar co-administered with oral chemotherapeutics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01042379	RECRUITING	Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer	QuantumLeap Healthcare Collaborative	2010-03-01	PHASE2
NCT06835400	NOT_YET_RECRUITING	Metastatic Breast Cancer	Health Hope Pharma	2025-09	PHASE3
NCT07580833	NOT_YET_RECRUITING	Metastatic Breast Cancer	Health Hope Pharma	2026-05	PHASE1
NCT04180384	COMPLETED	Solid Tumor	Athenex, Inc.	2015-09-23	PHASE2
NCT03892018	Terminated	Solid Tumor Adult	Athenex Inc.	2019-08-05	Phase 1
NCT04035473	COMPLETED	Solid Tumor	Athenex, Inc.	2015-08-01	PHASE1
NCT02963168	Unknown status	Solid Tumor	Athenex Inc.	2017-04-20	Phase 1
NCT01491204	COMPLETED	Advanced Solid Tumors	Hanmi Pharmaceutical Company Limited	2006-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the Encequidar (HM30181) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Encequidar acts as a potent and selective inhibitor of the ATP-binding cassette transporter P-glycoprotein, blocking ATP-dependent active efflux of substrate chemotherapeutics across cell membranes to enhance intracellular drug accumulation. By overcoming intestinal efflux barriers and restoring cellular sensitivity to cytotoxic agents, this target inhibition improves oral bioavailability to support tumor growth suppression in clinical trial settings such as solid tumors and metastatic breast cancer.

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>).