Clinical Trials

Multiple clinical trials, sponsored by HepaRegeniX GmbH and the Mayo Clinic, are evaluating HRX215 across Phase 1 and Phase 2 phases to support hepatic recovery in surgical oncology settings. Currently recruiting, a Phase 1/2 trial is examining the safety and efficacy of HRX215 in patients undergoing major hepatectomy for liver resections and colorectal carcinoma liver metastases. Additionally, a planned Phase 2 trial that is not yet recruiting aims to assess the inhibitor’s ability to promote remnant liver regeneration following surgery in patients with stage IV metastatic colorectal carcinoma and resectable malignant liver neoplasms.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07612007 NOT_YET_RECRUITING
Metastatic Colorectal Carcinoma; Metastatic Malignant Neoplasm in the Liver; Resectable Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8
Mayo Clinic
 2026-09-01 PHASE2
NCT06638502 RECRUITING
Liver Resection; Colorectal Carcinoma Liver Metastases
HepaRegeniX GmbH
 2025-05-06 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the HRX215 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HRX215 (Darizmetinib) functions as a potent, selective inhibitor of mitogen-activated protein kinase kinase 4 (MKK4) with an IC50 of 0.02 µM, preventing downstream activation of stress signaling pathways. By attenuating pro-apoptotic signaling and stimulating hepatocyte proliferation, HRX215 enhances liver regeneration and guards against acute liver failure in clinical settings involving extensive liver resection and colorectal carcinoma liver metastases.

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.