Clinical Trials

Multiple Phase I clinical trials sponsored by Novartis Pharmaceuticals evaluate the safety, tolerability, and preliminary efficacy of MAK683 in adult patients with advanced malignancies, including diffuse large B-cell lymphoma. These industry-sponsored studies, with recruitment statuses including active, not recruiting as well as terminated, highlight the compound's ongoing development for hematologic malignancies and solid tumors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02900651 TERMINATED
Diffuse Large B-cell Lymphoma
Novartis Pharmaceuticals
 2016-10-03 PHASE1
NCT02900651 Active not recruiting
Diffuse Large B-cell Lymphoma
Novartis Pharmaceuticals|Novartis
 2016-10-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-08-11)

Check the MAK683 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MAK683 is a selective inhibitor of embryonic ectoderm development (EED) that binds specifically to the EED subunit of Polycomb Repressive Complex 2, effectively disrupting complex integrity and suppressing trimethylation of histone H3 at lysine 27. By reversing methyltransferase-mediated epigenetic silencing and inhibiting tumor cell proliferation, MAK683 provides a targeted therapeutic strategy for malignancies such as diffuse large B-cell lymphoma.

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.