Belimumab is used to treat systemic lupus erythematosus (SLE), an autoimmune disease where the body's immune system attacks its own tissues, causing inflammation and damage to joints, skin, and organs. It works by reducing the activity of certain immune cells that cause the disease.[2] Benlysta is currently approved and in use across 13 indications[4].[1]
Benlysta is one of 241 monoclonal antibody programs targeting Lupus Nephritis. It is currently in Approved.
Indications
Total Trials
Active Trials
Competitors
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Competition
134 competitors in Systemic Lupus Erythematosus
Benlysta
Rituxan
Medrol
Rinvoq
Cytoxan
Gazyva
Sotyktu
Rapamune
Ianalumab
Fludara
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Clinical
Regulatory
Mar 9, 2011
BENLYSTA
NDA BLA125370
Mar 9, 2011
BENLYSTA
BLA BLA125370
Mar 30, 2012
BENLYSTA
NDA BLA125370
Dec 13, 2013
BENLYSTA
NDA BLA125370
Apr 3, 2014
BENLYSTA
NDA BLA125370
Dec 2, 2016
BENLYSTA
NDA BLA125370
Jan 18, 2017
BENLYSTA
NDA BLA125370
Jul 20, 2017
BENLYSTA
BLA BLA761043
Jul 20, 2017
BENLYSTA
NDA BLA761043
Jun 22, 2018
BENLYSTA
NDA BLA125370
Jun 22, 2018
BENLYSTA
NDA BLA761043
Apr 26, 2019
BENLYSTA
NDA BLA125370
Apr 26, 2019
BENLYSTA
NDA BLA761043
Sep 13, 2019
BENLYSTA
NDA BLA761043
Sep 13, 2019
BENLYSTA
NDA BLA125370
Jan 17, 2020
BENLYSTA
NDA BLA125370
Jan 17, 2020
BENLYSTA
NDA BLA761043
Sep 24, 2020
BENLYSTA
NDA BLA125370
Dec 16, 2020
BENLYSTA
NDA BLA125370
Dec 16, 2020
BENLYSTA
NDA BLA761043
Jul 26, 2022
BENLYSTA
NDA BLA125370
Jul 26, 2022
BENLYSTA
NDA BLA761043
Feb 15, 2023
BENLYSTA
NDA BLA125370
Feb 15, 2023
BENLYSTA
NDA BLA761043
Feb 9, 2024
BENLYSTA
NDA BLA125370
Feb 9, 2024
BENLYSTA
NDA BLA761043
May 16, 2024
BENLYSTA
NDA BLA125370
May 16, 2024
BENLYSTA
NDA BLA761043
Jun 20, 2025
BENLYSTA
NDA BLA125370
Jun 20, 2025
BENLYSTA
NDA BLA761043
Aug 21, 2026
BENLYSTA
NDA BLA125370
Aug 21, 2026
BENLYSTA
NDA BLA761043
Sources
Details