Ozmosi | Belimumab Drug Profile

Product Description

The drug, belimumab, which was approved on March 9, 2011, by FDA, is the first ever targeted biological for the treatment of SLE patients with active, autoantibody-positive disease, who are already on standard therapy. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3198539/)

Mechanisms of Action: BLyS Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Intravenous, Subcutaneous

FDA Designation: *

Approval Status: Approved

Approved Indications: None

Known Adverse Events: None

Company: GSK
Company Location: BRENTFORD MIDDLESEX X0 TW8 9GS
Company CEO: Emma Walmsley
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Belimumab

Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Korea, Mexico, Netherlands, Panama, Spain, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 26

Recent & Upcoming Milestones

Highest Development Phases

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT05338190	RITUX-PLUS 2	P3	Recruiting	Thrombocytopenia\|Purpura, Thrombocytopenic, Idiopathic	2026-11-14	19%	2023-09-12	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date\|Treatments\|Trial Status
2017-003051-35	BELI-SKIN	P3	Active, not recruiting	Skin Manifestations\|Lupus Erythematosus	2021-10-09		2022-03-13	Treatments
NCT03844061	NCT03844061	P2	Recruiting	Scleroderma, Diffuse	2025-06-30	12%	2023-09-15	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
2018-004645-16	Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE	P2	Active, not recruiting	Lupus Erythematosus, Systemic\|Lupus Erythematosus, Cutaneous	2029-12-27		2022-03-13	Treatments
NCT03949855	REBOOT	P2	Recruiting	Nephrotic Syndrome\|Glomerulonephritis, Membranous\|Kidney Diseases\|Nephrosis\|Membranous Nephropathy	2029-03-01	12%	2024-11-07
NCT06381453	BELief	P2	Recruiting	Hepatitis, Autoimmune	2028-04-30	12%	2025-08-27	Primary Endpoints\|Treatments
NCT05069051	BeliVeR	P2	Active, not recruiting	Lymphocytic Chronic B-Cell Leukemia\|Chronic Lymphoid Leukemia	2026-07-15	12%	2024-12-10	Primary Endpoints\|Treatments\|Trial Status
2024-512730-15-00	114055	P2	Active, not recruiting	Lupus Erythematosus, Systemic	2025-12-09		2025-05-02	Treatments
NCT05878717	BLISSc-ILD	P3	Recruiting	Scleroderma, Diffuse\|Lung Diseases, Interstitial	2027-05-17	37%	2025-04-03	Primary Endpoints\|Treatments
jRCT2031230153	jRCT2031230153	P3	Not yet recruiting	Lung Diseases, Interstitial\|Scleroderma, General	2027-03-05
jRCT2011240027	jRCT2011240027	P3	Not yet recruiting	Lung Diseases, Interstitial	2028-12-13
NCT06572384	BEconneCTD-ILD	P3	Recruiting	Lung Diseases, Interstitial	2028-10-18	22%	2024-08-30	Primary Endpoints\|Treatments\|Trial Status
NCT06716606	SSc-ILD	P3	Recruiting	Lung Diseases, Interstitial\|Scleroderma, Diffuse	2028-07-19	20%	2025-02-06	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
2023-503219-14-01	218224	P3	Recruiting	Scleroderma, General\|Lung Diseases, Interstitial	2027-07-30	37%	2025-05-02	Treatments
NCT05917288	NCT05917288	P1	Completed	Lupus Erythematosus, Systemic	2024-10-30	56%	2025-01-17	Patient Enrollment\|Primary Endpoints\|Treatments\|Trial Status
NCT03747159	SynBioSe-2	P3	Active, not recruiting	Lupus Erythematosus, Systemic	2024-06-07	50%	2024-10-18	Primary Completion Date\|Primary Endpoints\|Study Completion Date
CTR20223328	CTR20223328	P1	Completed	Lupus Erythematosus, Cutaneous\|Lupus Erythematosus, Systemic	2024-10-30		2025-04-29	Patient Enrollment\|Primary Completion Date\|Study Completion Date\|Treatments\|Trial Status
JapicCTI-163361	JapicCTI-163361	P2	Active	Lupus Erythematosus, Systemic	2028-02-16
2020-002622-87	2020-002622-87	P2	Active, not recruiting	Chronic Lymphoid Leukemia	2027-04-27		2022-03-13	Treatments
2023-509413-37-00	200908	P2	Active, not recruiting	Lupus Erythematosus, Systemic	2025-04-30		2025-05-02	Treatments
JapicCTI-195029	JapicCTI-195029	P2	Active	Lupus Erythematosus, Systemic	2023-03-08
jRCT2080224941	jRCT2080224941	P2	Completed	Lupus Erythematosus, Systemic	2023-03-08
jRCT2011250002	jRCT2011250002	P3	Not yet recruiting	Scleroderma, General\|Lung Diseases, Interstitial	2031-11-30
2023-509370-39-00	219855	P3	Not yet recruiting	Scleroderma, General\|Lung Diseases, Interstitial	2029-12-31	20%	2025-05-02	Treatments
2024-513018-36-00	221672	P3	Recruiting	Lung Diseases, Interstitial	2028-12-13		2025-05-02

Recent News Events

Date	Type	Title
11/27/2025	News Article	Inhaled Therapy in Respiratory Disease Market to Grow USD 16.22 Billion by 2034
11/19/2025	News Article	First Look at Roche/Genentech's Gazyva Shows Strong Early Enthusiasm in Lupus Nephritis Launch, According to Spherix Global Insights
11/19/2025	News Article	Autoimmunity BioSolutions Bolsters Leadership Team
10/20/2025	News Article	FDA Approves Gazyva® (obinutuzumab) for the Treatment of Adults with Lupus Nephritis

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Belimumab

Alternative Names: belimumab, benlysta, gsk-1550188, gsk1550188, gsk 1550188 Clinical Status: Inactive Latest Update: 2025-11-28 Latest Update Note: Clinical Trial Update