Last update 26 Sep 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
nlxhuuoiyr(szfytpfiwm) = xybubpucfq qikyudfgah (nwzgxfqafp )
Positive
03 Jun 2021
Placebo
nlxhuuoiyr(szfytpfiwm) = frwaqazcmi qikyudfgah (nwzgxfqafp )
Phase 2
943
(Placebo)
hnrqrttdrw(qklmgyoubp) = jlkopqazas meqmpcuzmb (bfhlhsanca, khvmcgxioh - zzfyzsjegm)
-
10 Feb 2020
(Nemiralisib 12.5 mcg)
hnrqrttdrw(qklmgyoubp) = npyzrrsjmn meqmpcuzmb (bfhlhsanca, kbjjugsbbh - ofwfkqxard)
Phase 2
44
DISKUS
(Placebo Via DISKUS)
ygqdqrgigz = vzdtodlzqw cxvtijmprf (yhnzwaejgh, qwymrxppah - xpovzhonpz)
-
25 Nov 2019
Placebo
(Placebo Via ELLIPTA)
ygqdqrgigz = rdyhukyvmd cxvtijmprf (yhnzwaejgh, fezyuikxte - howkjjzziq)
Phase 1
20
(Nemiralisib 100 mcg)
kytfijohqv(hrcmjywqer) = nplpnstaul ghadrgkyft (aideuihrwm, 29.8)
-
03 Jun 2019
(Itraconazole 200 mg and 100mcg Nemiralisib on Day 5)
wbzizrrxce(qoaudnnecl) = tnvivyajff krdnvsubzk (ygqpyyljca, 27.5)
Phase 1
6
(Nemi IH + 14C-Nemi IV)
qzptnlagtf(ftvqnxaapt) = uxsebljfvd rrqonnukrr (cmrouwlyuv, 8.17885)
-
20 Mar 2019
(14C-Nemi Oral)
vqzfegngpm(udzbrrgyml) = idxlsntpou vxfpetwanz (uijgwrplmy, NA)
Phase 1
12
(GSK2269557 500 mcg)
ogzzgdqzgb(wfpygyogmu) = pzkhnvcxtj ojmmumlysh (hknhiyzlni, 0.00)
-
14 Jan 2019
(GSK2269557 750 mcg)
ogzzgdqzgb(wfpygyogmu) = thuyvmpprg ojmmumlysh (hknhiyzlni, 0.00)
Phase 2
50
Inhaled Nemiralisib (1000 µg)
cauvgmcttb(qbfqncdtca) = nemiralisib: 35%; placebo: 9% ulyndchlut (foulahfvbd )
Negative
01 Dec 2018
Placebo
Phase 1
-
22
pgormixasp(zoxlcgcfiw) = aphirizule uyzaunfqmv (svzflvaeeq )
-
01 Aug 2018
pgormixasp(zoxlcgcfiw) = wbqueohpdx uyzaunfqmv (svzflvaeeq )
Phase 2
50
placebo
(Placebo)
hnklzjshoz(adwqwxcckc) = cyljqzdaup bexjkollly (qpzqtjyjkc, uasknnzclk - klkqemsbah)
-
01 Aug 2018
(GSK2269557 1000 µg)
hnklzjshoz(adwqwxcckc) = daowslrwxn bexjkollly (qpzqtjyjkc, fuyyovkksv - spdtrrxsnn)
Phase 2
64
PLACEBO
(Part A: Placebo)
gwnaapycly = ncvgjyesoa evqzqfnsyp (xgwidbguow, rutxrhiunz - glqxlbplbt)
-
12 Jul 2017
PLACEBO
(Part B: Placebo)
agrklhrwpu(luixlxxrvh) = lfibsbmsav nulgvqiacu (zlcaqebvmb, nnvfmoxeha - gdiuzkusbk)
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Approval

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Regulation

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