Belimumab

Overview

Belimumab is a fully human recombinant IgG1λ monoclonal antibody that inhibits soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B), a B cell survival factor. BLyS levels are often elevated in immunodeficient and autoimmune disorders, such as systemic lupus erythematosus (SLE). By binding to BLyS and blocking its interaction with B cell receptors, belimumab inhibits the survival of B cells. It is produced by recombinant DNA technology in a murine cell (NS0) expression system. Belimumab was first approved by the FDA on March 9, 2011, making it the newest drug to be approved for the treatment of SLE in more than 50 years. It is currently used to treat SLE and lupus nephritis.

Indication

In the US, belimumab is indicated to treat active systemic lupus erythematosus (SLE) and active lupus nephritis in patients aged five years and older who are receiving standard therapy. In Europe, belimumab is also used to treat SLE and lupus nephritis but only in adults. The efficacy of belimumab has not been evaluated in patients with severe active central nervous system lupus. Use of belimumab is not recommended in this situation.

Associated Conditions

Active Systemic Lupus Erythematosus
Lupus Nephritis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Investigate the Long-term Safety and Efficacy of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease	2024/12/04	NCT06716606	Phase 3	Recruiting	GlaxoSmithKline
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants and Healthy Chinese and Japanese Participants	2024/08/28	NCT06576271	Phase 1	Recruiting	GlaxoSmithKline
A Study of the Efficacy and Safety of Belimumab in Adults With Interstitial Lung Disease Associated With Connective Tissue Disease	2024/08/27	NCT06572384	Phase 3	Recruiting	GlaxoSmithKline
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)	2024/05/13	NCT06411249	Phase 4	Recruiting	GlaxoSmithKline
Belimumab After Rituximab in Resistant Primary Juvenile SS	2024/05/13	NCT06410833	Phase 4	Recruiting	Peking Union Medical College Hospital
Belimumab in Autoimmune Hepatitis	2024/04/24	NCT06381453	Phase 2	Recruiting	University Health Network, Toronto
Belimumab in SLE Synovial Inflammation and Lymph Nodes	2024/03/25	NCT06327724	N/A	Recruiting	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus	2023/06/23	NCT05917288	Phase 1	Completed	GlaxoSmithKline
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease	2023/05/26	NCT05878717	Phase 2	Recruiting	GlaxoSmithKline
Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis	2023/05/18	NCT05863936	Phase 3	Recruiting	Nanjing University School of Medicine

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
BENLYSTA	GlaxoSmithKline LLC	49401-088	SUBCUTANEOUS	200 mg in 1 mL	12/16/2020
BENLYSTA	GlaxoSmithKline LLC	49401-102	INTRAVENOUS	400 mg in 5 mL	12/16/2020
BENLYSTA	GlaxoSmithKline LLC	49401-101	INTRAVENOUS	120 mg in 1.5 mL	12/16/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Benlysta	GlaxoSmithKline (Ireland) Limited,12 Riverwalk,Citywest Business Campus,Dublin 24,Ireland	Authorised	7/13/2011
Benlysta	GlaxoSmithKline (Ireland) Limited,12 Riverwalk,Citywest Business Campus,Dublin 24,Ireland	Authorised	7/13/2011

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Benlysta Powder for Solution for Infusion 400mg	Hospira, Inc., GlaxoSmithKline Manufacturing S.P.A.	SIN14212P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	400mg/vial	8/21/2012
Benlysta Powder for Solution for Infusion 120mg	Hospira, Inc., GlaxoSmithKline Manufacturing S.P.A.	SIN14211P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	120mg/vial	8/21/2012

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BENLYSTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 400MG	N/A	葛兰素史克	N/A	N/A	8/14/2012
BENLYSTA SOLUTION FOR INJECTION IN PRE-FILLED PEN 200MG/ML	N/A	葛兰素史克	N/A	N/A	9/19/2019
BENLYSTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 120MG	N/A	葛兰素史克	N/A	N/A	8/14/2012

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
BENLYSTA belimumab 200 mg/mL solution for injection in a pre-filled pen	314922	GlaxoSmithKline Australia Pty Ltd	Medicine	A	11/27/2019
BENLYSTA belimumab 200 mg/mL solution for injection in a pre-filled syringe	314903	GlaxoSmithKline Australia Pty Ltd	Medicine	A	11/27/2019
BENLYSTA belimumab 120 mg powder for injection vial	173077	GlaxoSmithKline Australia Pty Ltd	Medicine	A	10/18/2012
BENLYSTA belimumab 400 mg powder for injection vial	173078	GlaxoSmithKline Australia Pty Ltd	Medicine	A	10/18/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BENLYSTA	GlaxoSmithKline Inc	02370050	Powder For Solution - Intravenous	120 MG / VIAL	8/24/2011
BENLYSTA	GlaxoSmithKline Inc	02470489	Solution - Subcutaneous	200 MG / 1 ML	5/14/2018
BENLYSTA	GlaxoSmithKline Inc	02470470	Solution - Subcutaneous	200 MG / 1 ML	N/A
BENLYSTA	GlaxoSmithKline Inc	02370069	Powder For Solution - Intravenous	400 MG / VIAL	8/24/2011

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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