Clinical Trials

Multiple Phase 1, Phase 1/2, and Phase 1b clinical trials evaluate MRX-2843 alone or with osimertinib across hematologic malignancies—such as relapsed or refractory acute myeloid, lymphoblastic, and mixed phenotype leukemias—and advanced solid neoplasms including EGFR-mutated non-small cell lung carcinoma. Sponsored by academic institutions like Emory University and commercial entities including Meryx Inc. and Betta Pharmaceuticals Co., Ltd., these studies assess safety, tolerability, pharmacokinetics, and preliminary efficacy. The trials display diverse recruitment statuses, including recruiting, active not recruiting, completed, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04762199 RECRUITING
Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
Emory University
2021-02-24 PHASE1
NCT04872478 RECRUITING
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia
Meryx, Inc.
2022-04-01 PHASE1
NCT03510104 COMPLETED
Advanced Cancer; Metastatic Cancer; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes
Meryx, Inc.
2018-05-22 PHASE1
NCT04946890 UNKNOWN
Acute Myeloid Leukemia Leukemia
Betta Pharmaceuticals Co., Ltd.
2021-07-01 PHASE1; PHASE2
NCT04872478 Recruiting
Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia|Mixed Phenotype Acute Leukemia
Meryx Inc.
2022-04-01 Phase 1
NCT03510104 Active not recruiting
Advanced Cancer|Metastatic Cancer|Neoplasms|Neoplasm Metastasis|Neoplastic Processes|Pathologic Processes
Meryx Inc.
2018-05-22 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-31)

Check the MRX-2843 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRX-2843 directly binds to and inhibits MERTK and FLT3 receptor tyrosine kinases, blocking downstream pro-survival signal transduction pathways and inducing apoptosis in malignant cells. By suppressing these key oncogenic drivers to inhibit tumor cell proliferation and survival, MRX-2843 demonstrates clinical relevance in the treatment of acute leukemias, non-small cell lung carcinoma, and advanced metastatic solid tumors.

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>).

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