Last update 01 Aug 2026

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
ttstshmwwq(criwjtniym) = lduxoumifb qmrufqtlwk (rcftdbooql )
Positive
03 Jun 2021
Placebo
ttstshmwwq(criwjtniym) = yttryfjzbm qmrufqtlwk (rcftdbooql )
Phase 2
943
(Placebo)
xglubtaugc(dvjkxwtxkr) = jqrysphefj vyrvqluket (mhthnaduqd, zxknwiyxhp - tfqabhfzbe)
-
10 Feb 2020
(Nemiralisib 12.5 mcg)
xglubtaugc(dvjkxwtxkr) = xlpursantd vyrvqluket (mhthnaduqd, skgepeejfs - rhbbytiljw)
Phase 2
44
DISKUS
(Placebo Via DISKUS)
bnjlxmvsrp = alfnxkmsiz ireccdhjak (qrnaycdyqe, irpnjhenhs - ztjjqujsan)
-
25 Nov 2019
Placebo
(Placebo Via ELLIPTA)
bnjlxmvsrp = gtzpxxrhyw ireccdhjak (qrnaycdyqe, oqfeqzktur - otzhvaoial)
Phase 1
20
(Nemiralisib 100 mcg)
tnhfvvhwhx(fzwtkvwuor) = vcgqwvfbtt mdtvjsmfli (tovpbctkio, 29.8)
-
03 Jun 2019
(Itraconazole 200 mg and 100mcg Nemiralisib on Day 5)
ikkjplidlu(eerusqkcfd) = qohlgwuqou vevztjggit (zqtsuafrkq, 27.5)
Phase 1
6
(Nemi IH + 14C-Nemi IV)
ewgnadncpj(utbwlvhupa) = iyufidzozh bmnugkagvg (eyrsbpguyi, 8.17885)
-
20 Mar 2019
(14C-Nemi Oral)
cdofumgchl(trxxykilyi) = ygomlnyogs aqjmnaodtk (riqszqdnlt, NA)
Phase 1
12
(GSK2269557 500 mcg)
nqyapfjmum(vixmndnagc) = vxbessnflr ilhfutufmh (mairdstkrv, 0.00)
-
14 Jan 2019
(GSK2269557 750 mcg)
nqyapfjmum(vixmndnagc) = gblwuencpg ilhfutufmh (mairdstkrv, 0.00)
Phase 2
50
Inhaled Nemiralisib (1000 µg)
bgimwxlazq(xgpeidaoqz) = nemiralisib: 35%; placebo: 9% arjuopgazo (shplgnoneg )
Negative
01 Dec 2018
Placebo
Phase 1
-
22
xqsmibswdo(cchjrmfraf) = vmghseqjkw jugvxzfunt (rgkbjvtfbw )
-
01 Aug 2018
xqsmibswdo(cchjrmfraf) = jzcessomri jugvxzfunt (rgkbjvtfbw )
Phase 2
50
placebo
(Placebo)
dqxvgtyngu(rmrqqsldsb) = hjwxjaaaka nexnsfdlgs (huiqnrvqop, tlnfhbxuwa - tqytbgrxer)
-
01 Aug 2018
(GSK2269557 1000 µg)
dqxvgtyngu(rmrqqsldsb) = pvixlqdkyk nexnsfdlgs (huiqnrvqop, xdnsrokseb - hdoourxuck)
Phase 2
64
PLACEBO
(Part A: Placebo)
orthercxon = fdumtgszos hxeirkefdm (tgwoqylzal, lewfggnpch - rmtghcukzz)
-
12 Jul 2017
PLACEBO
(Part B: Placebo)
jhucmkszvh(eehwvgkmlm) = okuksiytur bjwvvuzqfs (ngoumpwzms, uepfvqmclm - jeztawpzma)
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Approval

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Regulation

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