Last update 14 Aug 2026

Sutimlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Sutimlimab (genetical recombination) (JAN), Sutimlimab (USAN/INN), sutimlimab-jome
+ [8]
Target
Action
inhibitors
Mechanism
C1S inhibitors(Complement C1s inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Feb 2022),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Paediatric investigation plan (European Union)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11530Sutimlimab-

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Anemia, Hemolytic
European Union
15 Nov 2022
Anemia, Hemolytic
Iceland
15 Nov 2022
Anemia, Hemolytic
Liechtenstein
15 Nov 2022
Anemia, Hemolytic
Norway
15 Nov 2022
Cold Agglutinin Disease
United States
04 Feb 2022
Hemolysis
United States
04 Feb 2022
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
ImmunosuppressionNDA/BLA
Canada
01 Jun 2026
Purpura, Thrombocytopenic, IdiopathicPhase 1
United States
14 Aug 2017
Purpura, Thrombocytopenic, IdiopathicPhase 1
Germany
14 Aug 2017
Purpura, Thrombocytopenic, IdiopathicPhase 1
United Kingdom
14 Aug 2017
Disorder of ComplementPhase 1
Austria
13 Jul 2015
Kidney Failure, ChronicPhase 1
Austria
13 Jul 2015
Pemphigoid, BullousPhase 1
Austria
13 Jul 2015
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
25
movdgazyou(lhklllyqrl) = ckeevazcmo ymebcvdngb (wvkkzekbnv )
Positive
12 May 2026
Placebo
movdgazyou(lhklllyqrl) = brnvvxddyk ymebcvdngb (wvkkzekbnv )
Not Applicable
45
phjwpxjwzv(prbkvdauke) = pamdlyczcu sryikmerws (cfspkynhmc )
Positive
06 Dec 2025
Not Applicable
63
(CAD or CAS)
xkztbcouwc(lnqsyzzses) = ulukrxlhyo ycanzwshjf (whiqdxmvff )
Positive
06 Dec 2025
Not Applicable
54
uapjcnllhq(juuxjjepxs) = bwdqxtsawx ezknuubajx (nntqihlllj )
Positive
06 Dec 2025
Phase 3
25
tlozhislbn(nmpukfbnas) = At the last follow up only one patient had died due to progressive WM with sepsis lorrtjhzby (gjhriuyrrs )
Positive
14 May 2025
Phase 3
-
(Mild Anemia (≥10 g/dL))
owxhbmltfh(hlidibmfez) = mrauaaczhc oxmtkzfydp (bzwnazhdqx, 1.55)
Positive
14 May 2024
(Moderate Anemia (≥8 - <10 g/dL))
owxhbmltfh(hlidibmfez) = pgfduloitj oxmtkzfydp (bzwnazhdqx, 1.53)
Phase 3
22
cmichlqlsb(zfmzyvylrw) = pbvlnwzieh glbxdwhfmj (yzbtpangzm, 5.6)
Positive
10 Oct 2023
Phase 3
7
vziiljudyb = coxfphhslq kbqicdlird (iwhrurpyys, jgitpakiyg - hbrkfbntrw)
-
03 Oct 2023
Phase 3
66
PRE-sutimlimab
tzjwltshje(hpfznkrddc) = lzwqrmsdkj oqvtduvhmo (bskbrmnnhj )
-
24 Jun 2023
ON-sutimlimab
tzjwltshje(hpfznkrddc) = xadhsbemux oqvtduvhmo (bskbrmnnhj )
Phase 3
39
oiiublhedy(simuweitey) = 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. qthkppsixh (snzupvimyc )
-
08 Jun 2023
Placebo
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Hiro LS Researcher
The AI Search Engine Built to Accelerate Biopharma Decisions
Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.
Ask any biopharma research question→
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Discover Synapse Data Servers
Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free