Ralimetinib (LY2228820) dimesylate Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Ralimetinib (LY2228820) dimesylate has been evaluated in several Phase 1, Phase 1/2, and Phase 2 clinical trials for advanced and metastatic malignancies, including non-small cell lung, colorectal, glioblastoma, postmenopausal breast, and gynecologic cancers. With recruitment statuses listed as completed or terminated, these investigations were supported by both industry sponsors, such as Eli Lilly and Company, and prominent institutional research entities.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02364206	COMPLETED	Adult Glioblastoma	Centre Jean Perrin	2015-06-08	PHASE1; PHASE2
NCT01663857	COMPLETED	Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer	Eli Lilly and Company	2012-07	PHASE1; PHASE2
NCT02860780	COMPLETED	Advanced Cancer; Metastatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer	Eli Lilly and Company	2016-08-10	PHASE1
NCT02322853	TERMINATED	Postmenopausal; Metastatic Breast Cancer	Centre Francois Baclesse	2015-01	PHASE2
NCT02860780	Completed	Advanced Cancer\|Metastatic Cancer\|Colorectal Cancer\|Non-small Cell Lung Cancer	Eli Lilly and Company	2016-08-10	Phase 1
NCT02364206	Completed	Adult Glioblastoma	Centre Jean Perrin\|National Cancer Institute France\|ARC Foundation for Cancer Research	2015-06-08	Phase 1\|Phase 2
NCT02322853	Terminated	Postmenopausal\|Metastatic Breast Cancer	Centre Francois Baclesse\|National Cancer Institute France\|ARC Foundation for Cancer Research	2015-01	Phase 2
NCT01393990	COMPLETED	Advanced Cancer	Eli Lilly and Company	2008-09-04	PHASE1
NCT01393990	Completed	Advanced Cancer	Eli Lilly and Company	2008-09-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2019-08-14)

Check the Ralimetinib (LY2228820) dimesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ralimetinib dimesylate selectively binds to p38α and p38β MAPKs, inhibiting their catalytic activity and suppressing the downstream phosphorylation of cellular targets including MAPKAPK2 and HSP27. By disrupting these p38 MAPK-mediated signaling cascades, the compound suppresses tumor cell proliferation and survival, underlying its clinical evaluation in advanced solid tumors such as glioblastoma, ovarian cancer, and non-small cell lung cancer.

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>).