Drugs / Nemiralisib
last change Jun 2020 re-read 9 days ago

Nemiralisib

Small molecule targets PIK3CD via inhibition

Developed for
chronic obstructive pulmonary disease · activated PI3K-delta syndrome
Investigated by
GlaxoSmithKline

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT03398421 Jan → Mar 2018 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT03315559 Nov → Dec 2017 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT03189589 Jun → Jul 2017 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02972905 Oct → Dec 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02691325 Mar → Jun 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01762878 Jan → Oct 2013 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01462617 Jul 2011 → Mar 2012 asthma GlaxoSmithKline Completed No outcome recorded
Phase 26 trials · 2 missed
Phase 2 NCT03345407 Nov 2017 → Jan 2019 chronic obstructive pulmonary disease GlaxoSmithKline Terminated No outcome recorded
Phase 2 NCT02593539 Jul 2016 → Jun 2020 activated PI3K-delta syndrome GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT02522299 Nov 2015 → Jun 2018 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT02567708 Oct 2015 → Sep 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed Missed primary
Phase 2 NCT02294734 Mar 2015 → Feb 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT02130635 Jul 2014 → Aug 2015 chronic obstructive pulmonary disease GlaxoSmithKline Completed Missed primary

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2018-05-16 GlaxoSmithKline Results GSK’s industry-leading respiratory research and scientific innovation showcased at ATS conference gsk.com ↗
Inhaled PI3Kdelta Inhibitor Nemiralisib Improves Lung Function and Reduces Re-Exacerbations in Exacerbating Chronic Obstructive Pulmonary Disease (COPD) patients (PII116678)

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Nemiralisib “This randomized, double-blind, placebo-controlled, crossover study investigated the efficacy, safety, tolerability, and pharmacokinetics of a PI3Kδ inhibitor, nemiralisib...” PMID 30217958 ↗ Sep 2018
3

NCT03345407 ↗

NCT03398421 ↗

NCT02593539 ↗

Known as GSK-2269557 FREE BASE ChEMBL registry synonym — accepted as the source's own label CHEMBL2216859 ↗
Known as GSK-2269557A ChEMBL registry synonym — accepted as the source's own label CHEMBL2216859 ↗
Known as GSK2269557 “This randomized, double-blind, placebo-controlled, crossover study investigated the efficacy, safety, tolerability, and pharmacokinetics of a PI3Kδ inhibitor, nemiralisib...” PMID 30217958 ↗ Sep 2018
10

“Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)” NCT03345407 ↗

NCT01762878 ↗

NCT02130635 ↗

NCT03189589 ↗

NCT03315559 ↗

NCT02522299 ↗

NCT02691325 ↗

NCT02972905 ↗

NCT01462617 ↗

NCT02294734 ↗

Known as GSK2269557H “It will be prepared by blending GSK2269557 hemisuccinate salt (GSK2269557H) with lactose and magnesium stearate.” NCT03315559 ↗
Known as GSK2269557T “It will be prepared by dissolving a hemisuccinate salt (GSK2269557T) in normal saline.” NCT03315559 ↗
Known as NEMI “repeat doses of inhaled nemiralisib (NEMI)” NCT02593539 ↗
Known as Nemiralisib hemisuccinate ChEMBL registry synonym — accepted as the source's own label CHEMBL2216859 ↗
Known as Nemiralisib hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL2216859 ↗
Known as NEMIRALISIB SUCCINATE ChEMBL registry synonym — accepted as the source's own label CHEMBL2216859 ↗
Action Inhibit “phosphoinositides 3-kinases -delta (PI3K-delta) inhibitor” NCT01762878 ↗
1

“PI3-kinase p110-delta subunit inhibitor” CHEMBL2216859 ↗

Modality Small molecule — CHEMBL2216859 ↗
Route Inhaled “nebulised GSK2269557” NCT01462617 ↗
Target PIK3CD “PI3-kinase p110-delta subunit inhibitor” CHEMBL2216859 ↗