Clinical Trials

E7820 has been evaluated in several Phase 1 and Phase 2 clinical trials across diverse oncological indications, including advanced solid tumors, colorectal cancer, malignant lymphoma, acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia. Sponsored by entities such as Eisai Inc., PharmaBio Development Inc., and Memorial Sloan Kettering Cancer Center, these studies assessed dose escalation, pharmacokinetics, and efficacy in solid malignancies and splicing factor-mutated myeloid neoplasms. Although certain trials were terminated, multiple clinical trials have been successfully completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05024994 COMPLETED
Acute Myeloid Leukemia; Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia
Memorial Sloan Kettering Cancer Center
 2021-08-13 PHASE2
NCT01347645 TERMINATED
Colon Cancer; Rectal Cancer
Eisai Inc.
 2011-09-30 PHASE1; PHASE2
NCT01773421 COMPLETED
Advanced Solid Tumors
Eisai Inc.
 2011-06-30 PHASE1
NCT01347645 Terminated
Colon Cancer|Rectal Cancer
Eisai Inc.|PharmaBio Development Inc.
 2011-09-30 Phase 1|Phase 2
NCT01773421 Completed
Advanced Solid Tumors
Eisai Inc.
 2011-06-30 Phase 1
NCT01133990 TERMINATED
Colorectal Cancer
Eisai Inc.
 2010-03-04 PHASE1; PHASE2
NCT00309179 COMPLETED
Advanced Colorectal Cancer
Eisai Inc.
 2007-09-24 PHASE2
NCT00078637 COMPLETED
Neoplasms; Lymphoma, Malignant
Eisai Inc.
 2004-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-17)

Check the E7820 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

E7820 binds DDB1-CUL4 E3 ubiquitin ligase to induce targeted degradation of the RNA splicing factor RBM39, thereby disrupting pre-mRNA splicing biochemistry and downregulating integrin-mediated angiogenic pathways. This molecular cascade triggers selective cell apoptosis and inhibits endothelial sprout formation, ultimately suppressing vascular growth and tumor proliferation in clinical conditions such as advanced solid tumors, colorectal cancer, and myeloid malignancies.

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>).

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Note: Technical data last updated: Sep 1, 2026.