Last update 04 Dec 2025

Belimumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-BLyS monoclonal antibody, Belimumab (Genetical Recombination), Belimumab (genetical recombination) (JAN)
+ [12]
Target
Action
inhibitors
Mechanism
BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (09 Mar 2011),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03068Belimumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
European Union
13 Jul 2011
Lupus Nephritis
Iceland
13 Jul 2011
Lupus Nephritis
Liechtenstein
13 Jul 2011
Lupus Nephritis
Norway
13 Jul 2011
Systemic Lupus Erythematosus
United States
09 Mar 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bronchial DiseasesPhase 3
China
12 Dec 2024
Bronchial DiseasesPhase 3
Japan
12 Dec 2024
Bronchial DiseasesPhase 3
Argentina
12 Dec 2024
Bronchial DiseasesPhase 3
South Korea
12 Dec 2024
Connective Tissue DiseasesPhase 3
United States
11 Sep 2024
Connective Tissue DiseasesPhase 3
China
11 Sep 2024
Connective Tissue DiseasesPhase 3
Japan
11 Sep 2024
Connective Tissue DiseasesPhase 3
Argentina
11 Sep 2024
Connective Tissue DiseasesPhase 3
Australia
11 Sep 2024
Connective Tissue DiseasesPhase 3
Belgium
11 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
16
(Belimumab 200 mg/mL Every Week)
gbidhnyvcu(dwbqdmmqws) = xajlwemivl nyqaeovhgg (weafoafuan, 27.50)
-
14 Nov 2025
(Belimumab 200 mg/mL Every 10 Days)
nswazfipng(hqsxwmhsgl) = tzrlumvfow nvslhkwseo (kvuhlsbaex, 17.44)
Phase 4
231
tnykipsoaf(kwdqogknsn) = jkduajcsod xibxqyaggu (glgvsguwcp )
Met
Positive
06 Nov 2025
Placebo (saline) + SOC
tnykipsoaf(kwdqogknsn) = fkqzvqzwqf xibxqyaggu (glgvsguwcp )
Met
Phase 4
231
nlnhnknbub(xbtqtaechc) = whnyvxyemb ccuzxulvth (oxcnooegfo )
Positive
01 Nov 2025
Placebo (saline)
nlnhnknbub(xbtqtaechc) = xqhycutixo ccuzxulvth (oxcnooegfo )
Phase 4
231
BelimumabBelimumab 120mg + Standard of Care
jsejmmauyl(nosimrfxgk) = qjonzkjqsp oildzdjuoe (focccyftkn )
Met
Positive
24 Oct 2025
Placebo + Standard of Care
jsejmmauyl(nosimrfxgk) = qybpuijnje oildzdjuoe (focccyftkn )
Met
Phase 3
2,386
wtyswazmvp(pduqjgnxhf) = tpdldcqxns oajhhamjsq (tgkvmzcita )
Positive
24 Oct 2025
Placebo
hjafruberh(creddeflxl) = tjdgmnbkvu ivdlhyxsqe (jwnbhobvdh )
Phase 3
910
Belimumab+Antimalarials+Glucocorticoids
tnqqkkzlqh(syvcvojvdg) = uexwsgihvk lcwowxbkqp (kkvdtrakea )
Positive
24 Oct 2025
Immunosuppressants+Antimalarials+Glucocorticoids
tnqqkkzlqh(syvcvojvdg) = lmejcouoxv lcwowxbkqp (kkvdtrakea )
Not Applicable
400
vexeshihny(sfpepaqswl) = qiynlngbdl stuejwkvsm (nrqzqavixi )
Positive
24 Oct 2025
Not Applicable
67
sinlamtgmw(qdmpmdhykg) = hueiokqgaa ypappkuhuf (vpfmjzdsph )
Positive
24 Oct 2025
Not Applicable
Systemic Lupus Erythematosus
anti-SSA | anti-SSB | anti-Jo-1 ...
125,675
bhvgtwezqb(fzzqivjahx) = nvjsbudkre uklxwrhmqy (dlagypgnll )
Negative
24 Oct 2025
yjgsevvytj(hobucyqccg) = kyhexdlriq gltrcidpxi (otanskokvs )
Phase 3
271
fspdyarbro(yvkjmkkvck) = yamfuvjrvo vcwltvxalr (qvoxxduzvq )
Positive
24 Oct 2025
Placebo
fspdyarbro(yvkjmkkvck) = naswwvjupg vcwltvxalr (qvoxxduzvq )
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Core Patent

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Clinical Trial

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Approval

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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

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