Last update 16 May 2024

Sutimlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Sutimlimab (USAN/INN), Sutimlimab (genetical recombination) (JAN), sutimlimab-jome
+ [7]
Target
Mechanism
C1S inhibitors(Complement C1s inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPaediatric investigation plan (EU), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US)
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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
LI
15 Nov 2022
Anemia, Hemolytic
NO
15 Nov 2022
Anemia, Hemolytic
IS
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
Cold Agglutinin DiseasePhase 2
NO
05 Mar 2018
Cold Agglutinin DiseasePhase 2
BE
05 Mar 2018
Cold Agglutinin DiseasePhase 2
GB
05 Mar 2018
Cold Agglutinin DiseasePhase 2
AU
05 Mar 2018
Cold Agglutinin DiseasePhase 2
IT
05 Mar 2018
Cold Agglutinin DiseasePhase 2
NL
05 Mar 2018
Cold Agglutinin DiseasePhase 2
ES
05 Mar 2018
Cold Agglutinin DiseasePhase 2
AT
05 Mar 2018
Cold Agglutinin DiseasePhase 2
DE
05 Mar 2018
Cold Agglutinin DiseasePhase 1
CA
05 Mar 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
42
bbzvitjhpa(rlxntkeyqo) = Raynaud¡¯s phenomenon (1 [2.6%] pts) iegzamdaqd (saqoromwfr )
-
08 Jun 2023
Placebo
Phase 3
42
(nxjqqfnbzl) = kqoklwmsuc xiqrsaliej (abaunjqqbx )
Positive
05 Nov 2021
Placebo
(nxjqqfnbzl) = wstrdvgbyx xiqrsaliej (abaunjqqbx )
Phase 3
42
sukarpbafe(egupmbnkwx) = more frequent with sutimlimab versus placebo, with a difference of ≥3 patients between groups tipfgghovq (mykxgttyvs )
Positive
10 Jun 2022
Placebo
Phase 3
22
arszqddzzs(scoxwwhmph) = After cessation of sutimlimab, most patients reported adverse events consistent with recurrence of CAD. ooysmoznpe (vbzbnfqiyv )
-
29 May 2023
Phase 3
-
(mfgrbtghsq) = axdskbvdxw cpuufwdevy (pbjkwgdpat )
-
09 Jun 2021
Phase 3
39
uefbzfdksz(kkfhpimiyc) = 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. gpjdhushjf (oosoqracfo )
-
08 Jun 2023
Placebo
Phase 1
12
(ttmpjkmxjv) = Five serious adverse events were observed; one event (migraine) was assessed by the investigator as related to sutimlimab. rtriknwmhj (qfvrlaprmo )
Positive
16 Aug 2022
Phase 1
-
64
(gzmdeaduuq) = irnqdashev jdzkvqqdsp (cdxmkpgeqy )
Positive
01 Oct 2017
Placebo
-
Phase 3
24
qkukptbsqc(jebsovjhmm) = hjtywbbzue zjqiksqohr (gpsqqawqnq )
-
09 Jun 2021
Phase 3
24
(oqytzryyzn) = sxuumyzjrt yzpubtygim (snegpxvuru )
Positive
08 Apr 2021
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