Last update 25 Oct 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

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 4
67
zsdwehaxbs = hdmrklcjow gampyfinnh (znhtmuleqx, zkirceudll - vchtwdcwyn)
-
23 Jul 2025
Not Applicable
112
(Thrombocytopenia)
hzvjvhvpcg(vsfpcffota) = bzhvttjscj nsegrtiocw (zfpncsamdr, 5.5)
Positive
11 Jun 2025
Not Applicable
45
xbliurhnot(kgudwprzcp) = bexmztpzim upzoldrbkl (ieunkirdli )
Positive
11 Jun 2025
yqdnbnlulz(rdreyqrfnm) = gjfuuwsdug tvlhogmsll (fbjcmpmphs )
Phase 4
67
cwamjkzzef(smyqsajzbc) = sbyluxyoyx hjcmhyrhvf (ubdhdqgbrh )
Positive
11 Jun 2025
Phase 3
1,642
dqnmejklks(iffcwybfxv) = lolckzndke hfhbojsxii (ljglaupnrr )
-
14 Mar 2025
Placebo
dqnmejklks(iffcwybfxv) = cdfzjlixny hfhbojsxii (ljglaupnrr )
Not Applicable
195
zfcfflexfw(ueddplloph) = xburzqmcoa xxxebmzcdh (rwyozpgixl )
Similar
10 Nov 2024
zfcfflexfw(ueddplloph) = gbuikqhnor xxxebmzcdh (rwyozpgixl )
Phase 3
2,370
aoweiiwexg(fklhtkkhrh) = xekammbwcf zhgotlqoqr (jrworjnddm )
Positive
10 Nov 2024
Placebo
aoweiiwexg(fklhtkkhrh) = xbpjuvibpd zhgotlqoqr (jrworjnddm )
Not Applicable
4,750
hcmkqzngik(qrcmlxwbtg) = vxthwqaznq gjmhaesqie (pmenpulujv )
Positive
10 Nov 2024
prior immunosuppressant use
hcmkqzngik(qrcmlxwbtg) = lbfitqfqhj gjmhaesqie (pmenpulujv )
Not Applicable
23
resuymmxap(nekiqugdux) = uqktkvgzbt ioeoopwurb (xyfdeipufb )
Positive
10 Nov 2024
Phase 3
3,086
Belimumab+Standard Therapy
lfbxxdvbme(vwhqkuisah): HR = 0.72, P-Value = < 0.0001
Positive
10 Nov 2024
Placebo+Standard Therapy
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Translational Medicine

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Deal

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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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