Poseltinib Clinical Trials

Size	Price	Qty
5mg	USD 199

Clinical Trials

Poseltinib has been evaluated across several clinical trials spanning Phase 1 and Phase 2 studies led by sponsors such as Eli Lilly and Company and Seoul National University Hospital. Early Phase 1 trials evaluating safety, tolerability, and disposition in healthy subjects have been completed. In Phase 2 investigations, a clinical trial for rheumatoid arthritis was terminated, whereas a clinical trial evaluating poseltinib combination therapy in relapsed or refractory diffuse large B-cell lymphoma remains actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05335018	Recruiting	Relapsed/Refractory Diffuse Large B Cell Lymphoma	Seoul National University Hospital	2022-05-30	Phase 2
NCT03083561	Completed	Healthy	Eli Lilly and Company	2017-03-15	Phase 1
NCT02914379	Completed	Healthy	Eli Lilly and Company	2016-09	Phase 1
NCT02628028	Terminated	Rheumatoid Arthritis	Eli Lilly and Company	2016-08-22	Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Poseltinib selectively binds to Bruton's tyrosine kinase (BTK), thereby blocking downstream B-cell receptor signaling cascades and preventing the activation and proliferation of B lymphocytes. By suppressing BTK-dependent survival and inflammatory signaling pathways, poseltinib inhibits pathologic B-cell function, offering therapeutic relevance in B-cell malignancies such as diffuse large B-cell lymphoma and autoimmune disorders like rheumatoid arthritis.

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>).