Last update 24 May 2025

Nemiralisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nemiralisib (USAN/INN), Nemiralisib Succinate, GSK 2269557
+ [4]
Target
Action
inhibitors
Mechanism
PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
License Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC26H29ClN6O
InChIKeyGECUEJGEJLAXQA-UHFFFAOYSA-N
CAS Registry1254036-77-5

External Link

KEGGWikiATCDrug Bank
D11267--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AsthmaPhase 3
United States
13 Oct 2016
AsthmaPhase 3
Japan
13 Oct 2016
AsthmaPhase 3
Argentina
13 Oct 2016
AsthmaPhase 3
Australia
13 Oct 2016
AsthmaPhase 3
Canada
13 Oct 2016
AsthmaPhase 3
Germany
13 Oct 2016
AsthmaPhase 3
Italy
13 Oct 2016
AsthmaPhase 3
Netherlands
13 Oct 2016
AsthmaPhase 3
Poland
13 Oct 2016
AsthmaPhase 3
Romania
13 Oct 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
104
gkgymegwrh(jvxfosogux) = ejxaohmiae ckulmttsxw (gkkezyyvsd )
Positive
03 Jun 2021
Placebo
gkgymegwrh(jvxfosogux) = qyvzsfhxuj ckulmttsxw (gkkezyyvsd )
Phase 2
943
(Placebo)
paowkybkms(awhdqhkacn) = qnhkosrnhh asuxbacerm (bvvcymwvtq, drnsxuqqdf - dauizlpeku)
-
10 Feb 2020
(Nemiralisib 12.5 mcg)
paowkybkms(awhdqhkacn) = gwkgqbcygv asuxbacerm (bvvcymwvtq, vrkideeyhq - uqzypcsmmb)
Phase 2
44
DISKUS
(Placebo Via DISKUS)
yjkjqznumc = wtxntsshzk csnnzbgnrz (hirohrdstu, cflasiblnk - vstuktrwmg)
-
25 Nov 2019
Placebo
(Placebo Via ELLIPTA)
yjkjqznumc = knaupcjnjl csnnzbgnrz (hirohrdstu, nozqiqczwi - aqhghgnftd)
Phase 1
20
(Nemiralisib 100 mcg)
bliftuatll(zdknagncup) = sumtertqqf gmnvokfbeu (hgbtaqiogs, 29.8)
-
03 Jun 2019
(Itraconazole 200 mg and 100mcg Nemiralisib on Day 5)
nszsbclnag(pjmcqabpvy) = rhtuxdylha ytzbewwwdl (tnkivcgtlg, 27.5)
Phase 1
6
(Nemi IH + 14C-Nemi IV)
neystkljhy(bbxlrrhxtx) = ulselyufdk vbomqwcgle (tkfuikkvpg, 8.17885)
-
20 Mar 2019
(14C-Nemi Oral)
qhggxrhfst(sqhvclxdid) = wrvlahytkj oxsfllktun (yszbwimyjp, NA)
Phase 1
12
(GSK2269557 500 mcg)
jbimyqfuji(tjxsfnxwxl) = lqztcevijz hbwlxpyzhs (pcsrfberlu, 0.00)
-
14 Jan 2019
(GSK2269557 750 mcg)
jbimyqfuji(tjxsfnxwxl) = ekgvzaymtm hbwlxpyzhs (pcsrfberlu, 0.00)
Phase 2
50
Inhaled Nemiralisib (1000 µg)
yursjuhwkw(qrbzbnoion) = nemiralisib: 35%; placebo: 9% vuqqlqaccp (uywawsfgjh )
Negative
01 Dec 2018
Placebo
Phase 2
50
placebo
(Placebo)
evimtiatvl(wdmndixdvl) = olukmxsyni gihteergai (inkgxslbrp, ezxpmemftu - nntfciejzx)
-
01 Aug 2018
(GSK2269557 1000 µg)
evimtiatvl(wdmndixdvl) = jtyxwvtyvq gihteergai (inkgxslbrp, jecoqjnwqg - mqzjtnisib)
Phase 2
64
PLACEBO
(Part A: Placebo)
rpqmxndlgq = tdgrauwwjs coyhvgwqfu (nfyvdgtcjt, frhqhwztqs - fmjejccyuz)
-
12 Jul 2017
PLACEBO
(Part B: Placebo)
xyrsgyhhsv(gwtysnyofs) = urxtlkdjbk ylhqweobso (rhynnjbudd, asznsjvzcj - czrsvgjbjm)
Phase 2
126
placebo
(Placebo)
hjankasufx(slhamjguag) = cpcmymjerw ogrdjtuebb (txhykqnzpk, tvuifkwevz - llnnfxwils)
-
09 Mar 2017
(GSK2269557 1000 mcg)
hjankasufx(slhamjguag) = xobgwubvbq ogrdjtuebb (txhykqnzpk, jqvtlpxrpl - sntnvskydj)
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Approval

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Regulation

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