spesolimab   Click here for help

GtoPdb Ligand ID: 12169

Synonyms: BI-655130 | BI655130 | spesolimab-sbzo | Spevigo®
Approved drug Immunopharmacology Ligand
spesolimab is an approved drug (FDA and EMA (2022))
Compound class: Antibody
Comment: Spesolimab (BI-655130) is a monoclonal antibody that disrupts interleukin-36 (IL-36)/IL-36 receptor signalling. Blocking this pathway is a molecular mechanism with potential to treat inflammatory diseases in skin and other epithelial tissues [2-3,5,7], since IL-36R expression is restricted to epithelial cells that are in direct contact with the environment, including those in the skin. Spesolimab (BI-655130) appears to be related to MAB92 which was reported by Boehringer Ingelheim in 2017 [6], but we have been unable to perform direct sequence matches. The heavy and light chain sequences for spesolimab (from its INN record) are claimed in Boehringer Ingelheim's patent US9023995B2 [4].
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Summary of Clinical Use Click here for help
The FDA approved spesolimab (Spevigo®; Boehringer Ingelheim) as a treatment for generalized pustular psoriasis (GPP) flares in September 2022.
The FDA granted orphan designation in Feb. 2024 for the treatment of Netherton syndrome.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02978690 BI655130 Single Dose in Generalized Pustular Psoriasis Phase 1 Interventional Boehringer Ingelheim 2
NCT03782792 Effisayilâ„¢ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis Phase 2 Interventional Boehringer Ingelheim 1