Last update 01 Jul 2024

Sutimlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Sutimlimab (genetical recombination) (JAN), Sutimlimab (USAN/INN), sutimlimab-jome
+ [7]
Target
Mechanism
C1S inhibitors(Complement C1s inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), Paediatric investigation plan (EU)
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External Link

KEGGWikiATCDrug Bank
D11530--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia, Hemolytic
EU
15 Nov 2022
Anemia, Hemolytic
IS
15 Nov 2022
Anemia, Hemolytic
LI
15 Nov 2022
Anemia, Hemolytic
NO
15 Nov 2022
Cold Agglutinin Disease
US
04 Feb 2022
Hemolysis
US
04 Feb 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic thrombocytopeniaPhase 1
US
14 Aug 2017
Chronic thrombocytopeniaPhase 1
DE
14 Aug 2017
Chronic thrombocytopeniaPhase 1
GB
14 Aug 2017
Purpura, Thrombocytopenic, IdiopathicPhase 1
US
14 Aug 2017
Purpura, Thrombocytopenic, IdiopathicPhase 1
DE
14 Aug 2017
Purpura, Thrombocytopenic, IdiopathicPhase 1
GB
14 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
eclvpagnru(xvkdtjmhok) = zzfnkcbpqc jehheezwsh (jdmuxianed, 1.55)
Positive
14 May 2024
eclvpagnru(xvkdtjmhok) = tzafhduqwh jehheezwsh (jdmuxianed, 1.53)
Phase 3
7
nekvmlpwta(dtzljgapnc) = ljnigkbvfr pphaxnqswc (qoxoxlujvn, zwnsgixdmj - dhxchoioja)
-
03 Oct 2023
Phase 3
66
PRE-sutimlimab
ogfoacgbeb(gkchcthemb) = qdhhsdldmg slsyatqgdr (zhgyqnyeuh )
-
24 Jun 2023
ON-sutimlimab
ogfoacgbeb(gkchcthemb) = vferfvjoll slsyatqgdr (zhgyqnyeuh )
Phase 3
39
jtcfofovkv(hcimmemprw) = Thromboembolic events were observed in 2 (5.1%) pts (transient ischemic attack [n=1]; deep vein thrombosis [n=1]); both events occurred in pts with underlying risk factors for thromboembolism and were assessed as non-serious and unrelated to SUT by the Investigator. drdvooyhhx (tztofdgmfp )
-
08 Jun 2023
Placebo
Phase 3
42
btdndlutrz(bsajcyzodu) = Raynaud¡¯s phenomenon (1 [2.6%] pts) vzhwzzqtog (ozlhhaymuh )
-
08 Jun 2023
Placebo
Phase 3
22
nodealiedv(ykgdmzkffa) = After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. tmnvgcwhgu (dbtdixoetl )
-
29 May 2023
Phase 3
24
aqvgtvczuo(vjneamtmql) = yzojzqrpuc xjtolksbyu (fjxqkmnklr, ljrsmylemr - izxztzxbbh)
-
31 Oct 2022
Phase 1
12
lszmwzxvvt(nhanmgchtn) = Five serious adverse events were observed; one event (migraine) was assessed by the investigator as related to sutimlimab. chqfkizsmh (yikagomcjo )
Positive
16 Aug 2022
Phase 3
42
jmeqkwjzuo(amummbwqte) = more frequent with sutimlimab versus placebo, with a difference of ≥3 patients between groups chydjpbbod (dsvfnwfkor )
Positive
10 Jun 2022
Placebo
Phase 3
42
omfeetqejo(flcfzieuhw) = tfewnjtusw kgdctslalz (oqoctfhtha )
Positive
05 Nov 2021
Placebo
omfeetqejo(flcfzieuhw) = kirabbfzdc kgdctslalz (oqoctfhtha )
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