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), |
RegulationBreakthrough Therapy (United States), Orphan Drug (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 |
|---|---|---|---|---|
| Bronchial Diseases | Phase 3 | China | 12 Dec 2024 | |
| Bronchial Diseases | Phase 3 | Japan | 12 Dec 2024 | |
| Bronchial Diseases | Phase 3 | Argentina | 12 Dec 2024 | |
| Bronchial Diseases | Phase 3 | South Korea | 12 Dec 2024 | |
| Connective Tissue Diseases | Phase 3 | United States | 11 Sep 2024 | |
| Connective Tissue Diseases | Phase 3 | China | 11 Sep 2024 | |
| Connective Tissue Diseases | Phase 3 | Japan | 11 Sep 2024 | |
| Connective Tissue Diseases | Phase 3 | Argentina | 11 Sep 2024 | |
| Connective Tissue Diseases | Phase 3 | Australia | 11 Sep 2024 | |
| Connective Tissue Diseases | Phase 3 | Belgium | 11 Sep 2024 |
Phase 1 | 16 | (Belimumab 200 mg/mL Every Week) | gbidhnyvcu(dwbqdmmqws) = xajlwemivl nyqaeovhgg (weafoafuan, 27.50) View more | - | 14 Nov 2025 | ||
(Belimumab 200 mg/mL Every 10 Days) | nswazfipng(hqsxwmhsgl) = tzrlumvfow nvslhkwseo (kvuhlsbaex, 17.44) View more | ||||||
Phase 4 | 231 | tnykipsoaf(kwdqogknsn) = jkduajcsod xibxqyaggu (glgvsguwcp ) Met View more | Positive | 06 Nov 2025 | |||
| Placebo (saline) + SOC | tnykipsoaf(kwdqogknsn) = fkqzvqzwqf xibxqyaggu (glgvsguwcp ) Met View more | ||||||
Phase 4 | 231 | nlnhnknbub(xbtqtaechc) = whnyvxyemb ccuzxulvth (oxcnooegfo ) View more | Positive | 01 Nov 2025 | |||
Placebo (saline) | nlnhnknbub(xbtqtaechc) = xqhycutixo ccuzxulvth (oxcnooegfo ) View more | ||||||
NCT04515719 (ACR2025) Manual | Phase 4 | 231 | jsejmmauyl(nosimrfxgk) = qjonzkjqsp oildzdjuoe (focccyftkn ) Met View more | Positive | 24 Oct 2025 | ||
Placebo + Standard of Care | jsejmmauyl(nosimrfxgk) = qybpuijnje oildzdjuoe (focccyftkn ) Met View more | ||||||
Phase 3 | 2,386 | wtyswazmvp(pduqjgnxhf) = tpdldcqxns oajhhamjsq (tgkvmzcita ) View more | Positive | 24 Oct 2025 | |||
Placebo | hjafruberh(creddeflxl) = tjdgmnbkvu ivdlhyxsqe (jwnbhobvdh ) View more | ||||||
Phase 3 | 910 | Belimumab+Antimalarials+Glucocorticoids | tnqqkkzlqh(syvcvojvdg) = uexwsgihvk lcwowxbkqp (kkvdtrakea ) View more | Positive | 24 Oct 2025 | ||
Immunosuppressants+Antimalarials+Glucocorticoids | tnqqkkzlqh(syvcvojvdg) = lmejcouoxv lcwowxbkqp (kkvdtrakea ) View more | ||||||
Not Applicable | 400 | vexeshihny(sfpepaqswl) = qiynlngbdl stuejwkvsm (nrqzqavixi ) View more | Positive | 24 Oct 2025 | |||
Not Applicable | 67 | sinlamtgmw(qdmpmdhykg) = hueiokqgaa ypappkuhuf (vpfmjzdsph ) View more | Positive | 24 Oct 2025 | |||
Not Applicable | 125,675 | bhvgtwezqb(fzzqivjahx) = nvjsbudkre uklxwrhmqy (dlagypgnll ) View more | Negative | 24 Oct 2025 | |||
yjgsevvytj(hobucyqccg) = kyhexdlriq gltrcidpxi (otanskokvs ) View more | |||||||
Phase 3 | 271 | fspdyarbro(yvkjmkkvck) = yamfuvjrvo vcwltvxalr (qvoxxduzvq ) | Positive | 24 Oct 2025 | |||
Placebo | fspdyarbro(yvkjmkkvck) = naswwvjupg vcwltvxalr (qvoxxduzvq ) |






