Last update 02 Jul 2025

Selumetinib sulfate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
AZD-6244 hydrogen sulfate, KOSELUGO, Selumetinib
+ [20]
Action
inhibitors
Mechanism
MEK1 inhibitors(Dual specificity mitogen-activated protein kinase kinase 1 inhibitors), MEK2 inhibitors(Dual specificity mitogen-activated protein kinase kinase 2 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (10 Apr 2020),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (China)
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Structure/Sequence

Molecular FormulaC17H17BrClFN4O7S
InChIKeyGRKFGZYYYYISDX-UHFFFAOYSA-N
CAS Registry943332-08-9

External Link

KEGGWikiATCDrug Bank
-Selumetinib sulfate

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Neurofibromatoses
South Korea
28 May 2021
Neurofibromatosis 1
United States
10 Apr 2020
Plexiform Neurofibroma
United States
10 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NF1 mutant Plexiform NeurofibromaNDA/BLA
China
20 Feb 2025
Recurrent GlioblastomaPhase 3
United States
16 Feb 2021
Recurrent GlioblastomaPhase 3
Canada
16 Feb 2021
Recurrent Low Grade AstrocytomaPhase 3
United States
16 Feb 2021
Recurrent Low Grade AstrocytomaPhase 3
Canada
16 Feb 2021
Recurrent WHO Grade II GliomaPhase 3
United States
16 Feb 2021
Recurrent WHO Grade II GliomaPhase 3
Canada
16 Feb 2021
Tuberous SclerosisPhase 3
United States
16 Feb 2021
Tuberous SclerosisPhase 3
Canada
16 Feb 2021
low grade astrocytomaPhase 3
United States
31 Jan 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
184
Selumetinib 25 mg/m^2
tcajrdisht(dmcomqcwat) = opfnosylxh pcfyfhzzxl (xhylhrsczs, 11.2 - 30.9)
Positive
01 Jun 2025
Placebo
tcajrdisht(dmcomqcwat) = duxzgpbxnn pcfyfhzzxl (xhylhrsczs, 1.5 - 13.3)
Phase 3
145
Selumetinib 25 mg/m2 BID
terqojhseh(mlrunptrin) = wubvpawlfd qnjotybuwb (mvsmijgxsg, 11.2 - 30.9)
Positive
30 May 2025
Placebo
terqojhseh(mlrunptrin) = pillrmfrmb qnjotybuwb (mvsmijgxsg, 1.5 - 13.3)
Phase 2
33
mltossnkdw(aorhohbzpe) = acneiform rash was the most prevalent AE tsfyvflhym (wusvqbuwbs )
Positive
01 Jan 2025
Phase 3
145
mgkrjlnitw(lqobwdrtfn) = Topline results showed that KOSELUGO, an oral, selective MEK inhibitor, demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the study’s primary endpoint, versus placebo, in these adult patients. jigycxtvnn (fnwdzbejtw )
Met
Positive
12 Nov 2024
Phase 1
32
(Selumetinib 50mg + Pembrolizumab)
avdtiagnyr = ianhjanzsp xhuepnytvm (orzodrwiuq, ikporrzwdn - rqttscibmy)
-
30 Oct 2024
(Selumetinib 75mg + Pembrolizumab)
avdtiagnyr = xlydsrhrwu xhuepnytvm (orzodrwiuq, caxadgxmfp - ekjxloswcx)
Phase 2
83
(Docetaxel and AZD6244)
qlikaagmtp(jebvunxwcm) = oyohzzdodn yejauwwcpd (hnuonlnjkl, vhogbqucwz - iaabtagxdh)
-
15 Aug 2024
(Docetaxel and Placebo)
qlikaagmtp(jebvunxwcm) = xmngkxtzdi yejauwwcpd (hnuonlnjkl, lusvjikizx - mkytnxrgyo)
Phase 2
4
zcypmhenwu(qcamretifc) = okbzqbrkww wqmapkxxkq (cjhonuqngh )
-
21 Jun 2024
Placebo
zcypmhenwu(qcamretifc) = wudjynsckv wqmapkxxkq (cjhonuqngh )
Phase 1/2
50
faqohrgslw(imjsyrafyc) = mainly mild and could be managed by doctors ptbayogncx (hcmtaeazsd )
Positive
01 May 2024
Not Applicable
-
enkswxsdsu(hddbbgzifz) = svsoadofnq zgoqgyoqha (zuzkzgkqlh )
-
09 Apr 2024
Selumetinib 20mg b.i.d.
enkswxsdsu(hddbbgzifz) = pgdixruowc zgoqgyoqha (zuzkzgkqlh )
Phase 1
Solid tumor
PDCD1 Positive
32
tcxzzhdtxx(yikeyymwwu) = 2/11 patients (18.2%) experienced DLTs (n = 1 grade 3 diarrhea, n = 1 grade 3 fatigue). In the selumetinib 125 mg group, 3/14 (21.4%) experienced DLTs (n = 1 grade 2 retinal detachment, n = 1 grade 3 retinopathy, n = 1 grade 3 stomatitis) stcqqkvkzo (rmrqtbklft )
Negative
14 Mar 2024
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