Nemiralisib Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored by GlaxoSmithKline have evaluated nemiralisib (GSK-2269557) in Phase 1 and Phase 2 studies for chronic obstructive pulmonary disease and activated PI3K-delta syndrome. Completed early-phase trials established the safety, tolerability, and pharmacokinetics of nemiralisib in chronic obstructive pulmonary disease, alongside a clinical trial evaluating repeat inhaled dosing in activated PI3K-delta syndrome. However, a separate Phase 2 dose-finding study in chronic obstructive pulmonary disease was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02593539	COMPLETED	Activated PI3K-delta Syndrome	GlaxoSmithKline	2016-07-22	PHASE2
NCT03345407	TERMINATED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2017-11-28	PHASE2
NCT03398421	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2018-01-17	PHASE1
NCT03398421	Completed	Pulmonary Disease Chronic Obstructive	GlaxoSmithKline	2018-01-17	Phase 1
NCT03189589	Completed	Pulmonary Disease Chronic Obstructive	GlaxoSmithKline	2017-06-15	Phase 1
NCT02972905	Completed	Pulmonary Disease Chronic Obstructive	GlaxoSmithKline	2016-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-06-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nemiralisib (GSK-2269557) is a potent and selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor with a pKi of 9.9 that binds the PI3Kδ catalytic subunit, suppressing downstream Akt phosphorylation and reducing pro-inflammatory cellular signaling in immune cells. By inhibiting leukocyte activation and mediator release within the respiratory tract, this targeted mechanism attenuates chronic pulmonary inflammation associated with conditions such as chronic obstructive pulmonary disease and activated PI3K-delta syndrome.

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>).