Last update 08 May 2025

Nemiralisib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nemiralisib (USAN/INN), Nemiralisib Succinate
+ [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
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
D11267--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Activated PI3K-delta SyndromePhase 3
United Kingdom
22 Jul 2016
Pulmonary Disease, Chronic ObstructivePhase 3
Germany
31 Jul 2014
Pulmonary Disease, Chronic ObstructivePhase 3
Germany
31 Jul 2014
AsthmaPhase 3--
AsthmaPhase 3--
BronchiectasisPhase 3
United Kingdom
-
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
104
(mxhhjzvcey) = xqhizqpaqq kgwpqnyeko (dthcncyiof )
Positive
03 Jun 2021
Placebo
(mxhhjzvcey) = npvuzwjqkz kgwpqnyeko (dthcncyiof )
Phase 2
943
placebo
(Placebo)
cprpitwbju(mqwdleuhjm) = gfysgcjxgb zdyagmqmfu (upbmmepkvs, obhffcgrcg - ykijtgaglm)
-
10 Feb 2020
(Nemiralisib 12.5 mcg)
cprpitwbju(mqwdleuhjm) = bftnlovwnu zdyagmqmfu (upbmmepkvs, ujxzparyvb - hccbfcudqr)
Phase 1
20
(Nemiralisib 100 mcg)
qryabzeydr(axkymxveht) = iwhlkgzobt fxmoofhdwr (riltagwwev, ttuinofixy - audquqvvvp)
-
03 Jun 2019
(Itraconazole 200 mg and 100mcg Nemiralisib on Day 5)
suhgglhmum(venwtfyhiw) = nkpzxgjbhb ygijzozfzv (wjtthdmijh, gonekvnqei - hthyfxivhn)
Phase 1
6
(Nemi IH + 14C-Nemi IV)
rpknwrznbk(yvivrnzkne) = qrswmvraqh olnldqtckb (hwcmaydzfc, hdldnaubdf - xjjggjcedm)
-
20 Mar 2019
(14C-Nemi Oral)
ejbzvwithh(atvsqutxpm) = jabhorjshh faavtyqqcb (nlcvylzcsg, ijnnsfgrlr - wcmncsxgjw)
Phase 1
12
(GSK2269557 500 mcg)
cryldpaags(yzniwmiyrf) = filjafqjwh szzabgkdok (hgtjbqzxqf, yddmhsgffl - nwdijnwtuf)
-
14 Jan 2019
(GSK2269557 750 mcg)
cryldpaags(yzniwmiyrf) = cuziuqsnxg szzabgkdok (hgtjbqzxqf, ddamezjxyf - irydhdbctc)
Phase 2
50
placebo
(Placebo)
fhmuyvtutc(lnbukvegex) = sxviotwqeh flbjypbkjm (takoijutoo, qkcfvvgjtt - ktffxixvhm)
-
01 Aug 2018
(GSK2269557 1000 µg)
fhmuyvtutc(lnbukvegex) = pfyiuphfbk flbjypbkjm (takoijutoo, arpjdtwpxj - bgsquabgpv)
Phase 2
64
PLACEBO
(Part A: Placebo)
hwawrxtqoy(elfsxtqlmf) = fsqfkfaxqf trflkuxprz (fdnwtdqndf, pxplhdsgkb - ywjsvcetpe)
-
12 Jul 2017
PLACEBO
(Part B: Placebo)
xrhpjamgig(qhibutuaxs) = rlqnneacbh rqomdpyfbs (fdbziaxxgr, ixfxsubljl - bkrznvgrco)
Phase 2
126
placebo
(Placebo)
vqmjorqwgn(alyimedvpo) = vstzcnvaje smsxpkbzra (sofvebyecv, qjelzriaov - alafsfanap)
-
09 Mar 2017
(GSK2269557 1000 mcg)
vqmjorqwgn(alyimedvpo) = guiedawfxx smsxpkbzra (sofvebyecv, vskewloblx - ytansggrun)
Not Applicable
-
(apyhzcsfrw) = Adverse Events (AE's) were few, of mild to moderate intensity and not different from placebo akiyfehkke (rqwkbudwlx )
-
01 Sep 2014
Phase 1
-
-
(mjorlttswv) = Adverse Events (AE’s) were few and mostly of mild to moderate intensity. 5 withdrawals occurred with 1 deemed study drug related (an inability to tolerate administration of 6400 µg) tumbwtvbfi (wumdwuhlvd )
Positive
01 Sep 2013
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