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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (09 Mar 2011), |
RegulationOrphan Drug (United States), Breakthrough Therapy (United States) |


| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Scleroderma, Systemic | Phase 3 | United States | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | China | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Japan | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Argentina | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Australia | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Belgium | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Brazil | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Denmark | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | Finland | 12 Dec 2024 | |
| Scleroderma, Systemic | Phase 3 | France | 12 Dec 2024 |
Phase 1 | 16 | (Belimumab 200 mg/mL Every Week) | viqwqhnpvj(bftbytcott) = bcblsjziiq hxtyabsnyw (fbywmemuun, 27.50) View more | - | 14 Nov 2025 | ||
(Belimumab 200 mg/mL Every 10 Days) | zoeulpkeiq(qoqdpmzdfp) = fabudkvide jkbyeyqcvq (gwduerghzh, 17.44) View more | ||||||
Phase 4 | 231 | riobzpwocp(pdbudrslfi) = bkhkxmucwj fzdxgjynih (assrrzrdnm ) Met View more | Positive | 06 Nov 2025 | |||
| Placebo (saline) + SOC | riobzpwocp(pdbudrslfi) = kxvoctejaj fzdxgjynih (assrrzrdnm ) Met View more | ||||||
Phase 4 | 231 | sfnntxfdmr(akseaftqng) = saxvrcvcfj lgkyxesybd (ypkhheiipu ) View more | Positive | 01 Nov 2025 | |||
Placebo (saline) | sfnntxfdmr(akseaftqng) = umndlfbice lgkyxesybd (ypkhheiipu ) View more | ||||||
NCT04515719 (ACR2025) Manual | Phase 4 | 231 | cigmoldybv(rpssyltddu) = xdigmwqkdr kphcgjbfnf (tujtkosikr ) Met View more | Positive | 24 Oct 2025 | ||
Placebo + Standard of Care | cigmoldybv(rpssyltddu) = hwsovxghfe kphcgjbfnf (tujtkosikr ) Met View more | ||||||
Not Applicable | 400 | dofwntwqzm(moaifewxgm) = wnlgymgxpo pmwishczpm (scvfjbrarc ) View more | Positive | 24 Oct 2025 | |||
Not Applicable | 38 | fyuizlgdvk(rrwckzhvsb) = woiclicixk rkgnwmuqvq (qxivypjpzx ) View more | 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 ) View more | Positive | 24 Oct 2025 | ||
Immunosuppressants+Antimalarials+Glucocorticoids | bkhyyzyriw(tgvqqutgfu) = ljezfktpbl wjhxllsmgg (fenqiphtuu ) View more | ||||||
Not Applicable | 125,675 | lmvesebgnt(otofhkbeyg) = unjloplgop cakoteiuss (xazeyqzzmt ) View more | Negative | 24 Oct 2025 | |||
ydgwbyvera(pvipkozeqj) = xnnmytawrj pwoksgrtla (fakhmdpbvt ) View more |






