Indisulam (E7070) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Indisulam (E7070) has been evaluated in several Phase 1, Phase 1/2, and Phase 2 clinical trials assessing single-agent safety and chemotherapeutic combinations for advanced solid malignancies, including gastric, colorectal, metastatic breast, skin melanoma, and unspecified adult solid tumors. Sponsored by commercial entities such as Eisai and academic organizations like the European Organisation for Research and Treatment of Cancer (EORTC), these trials have all reached completed or terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00165594	Terminated	Gastric Cancer	Eisai Co. Ltd.\|Eisai Inc.	2005-02	Phase 1\|Phase 2
NCT00165854	Completed	Colorectal Cancer (CRC)	Eisai Limited\|Eisai Inc.	2003-03	Phase 2
NCT00014625	COMPLETED	Melanoma (Skin)	European Organisation for Research and Treatment of Cancer - EORTC	2001-02	PHASE2
NCT00003976	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	European Organisation for Research and Treatment of Cancer - EORTC	1998-03	PHASE1
NCT00003981	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	European Organisation for Research and Treatment of Cancer - EORTC	1998-04	PHASE1
NCT00165867	COMPLETED	Colorectal Cancer	Eisai Limited	2005-04	PHASE2
NCT00165880	TERMINATED	Metastatic Breast Cancer	Eisai Limited	2004-12	PHASE2

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

Check the Indisulam (E7070) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indisulam acts as a potent carbonic anhydrase inhibitor targeting cytosolic isozymes I and II as well as tumor-associated transmembrane isozyme IX, thereby suppressing cyclin E expression and inhibiting CDK2 phosphorylation to induce cell cycle arrest at the G1 to S transition. This targeted disruption of cell cycle progression and cellular microenvironment regulation mediates tumor cell antiproliferative activity, providing the therapeutic rationale for evaluating Indisulam in clinical trials for advanced solid tumors, including colorectal, gastric, and breast cancers.

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>).