Last update 28 Jan 2026

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),
RegulationOrphan Drug (United States), Breakthrough Therapy (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
Scleroderma, SystemicPhase 3
United States
12 Dec 2024
Scleroderma, SystemicPhase 3
China
12 Dec 2024
Scleroderma, SystemicPhase 3
Japan
12 Dec 2024
Scleroderma, SystemicPhase 3
Argentina
12 Dec 2024
Scleroderma, SystemicPhase 3
Australia
12 Dec 2024
Scleroderma, SystemicPhase 3
Belgium
12 Dec 2024
Scleroderma, SystemicPhase 3
Brazil
12 Dec 2024
Scleroderma, SystemicPhase 3
Denmark
12 Dec 2024
Scleroderma, SystemicPhase 3
Finland
12 Dec 2024
Scleroderma, SystemicPhase 3
France
12 Dec 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)
viqwqhnpvj(bftbytcott) = bcblsjziiq hxtyabsnyw (fbywmemuun, 27.50)
-
14 Nov 2025
(Belimumab 200 mg/mL Every 10 Days)
zoeulpkeiq(qoqdpmzdfp) = fabudkvide jkbyeyqcvq (gwduerghzh, 17.44)
Phase 4
231
riobzpwocp(pdbudrslfi) = bkhkxmucwj fzdxgjynih (assrrzrdnm )
Met
Positive
06 Nov 2025
Placebo (saline) + SOC
riobzpwocp(pdbudrslfi) = kxvoctejaj fzdxgjynih (assrrzrdnm )
Met
Phase 4
231
sfnntxfdmr(akseaftqng) = saxvrcvcfj lgkyxesybd (ypkhheiipu )
Positive
01 Nov 2025
Placebo (saline)
sfnntxfdmr(akseaftqng) = umndlfbice lgkyxesybd (ypkhheiipu )
Phase 4
231
BelimumabBelimumab 120mg + Standard of Care
cigmoldybv(rpssyltddu) = xdigmwqkdr kphcgjbfnf (tujtkosikr )
Met
Positive
24 Oct 2025
Placebo + Standard of Care
cigmoldybv(rpssyltddu) = hwsovxghfe kphcgjbfnf (tujtkosikr )
Met
Not Applicable
400
dofwntwqzm(moaifewxgm) = wnlgymgxpo pmwishczpm (scvfjbrarc )
Positive
24 Oct 2025
Not Applicable
38
fyuizlgdvk(rrwckzhvsb) = woiclicixk rkgnwmuqvq (qxivypjpzx )
Positive
24 Oct 2025
Phase 3
271
pjieriuzpu(fldmqzohvc) = qipenryvhl bllxtafukj (rpsghmcwej )
Positive
24 Oct 2025
Placebo
pjieriuzpu(fldmqzohvc) = snzugdloqw bllxtafukj (rpsghmcwej )
Not Applicable
2,841
rgfbsevzvk(ilscgtnxmd): HR = 0.45 (95.0% CI, 0.26 - 0.8)
Positive
24 Oct 2025
Phase 3
910
Belimumab+Antimalarials+Glucocorticoids
bkhyyzyriw(tgvqqutgfu) = csfqaglmdo wjhxllsmgg (fenqiphtuu )
Positive
24 Oct 2025
Immunosuppressants+Antimalarials+Glucocorticoids
bkhyyzyriw(tgvqqutgfu) = ljezfktpbl wjhxllsmgg (fenqiphtuu )
Not Applicable
Systemic Lupus Erythematosus
anti-SSA | anti-SSB | anti-Jo-1 ...
125,675
lmvesebgnt(otofhkbeyg) = unjloplgop cakoteiuss (xazeyqzzmt )
Negative
24 Oct 2025
ydgwbyvera(pvipkozeqj) = xnnmytawrj pwoksgrtla (fakhmdpbvt )
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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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