MALT1 is a key mediator of NF-κB signaling and an emerging therapeutic target in B-cell malignancies and autoimmune diseases. SGR-1505, a potent MALT1 inhibitor, is being clinically evaluated for its therapeutic potential. In this study, we developed and validated a reliable and high-throughput LC-MS/MS method for the quantitation of SGR-1505 in human plasma (K₂EDTA) to support clinical pharmacokinetic studies. This work exemplifies the critical role of CRO-led bioanalysis in bridging early discovery and clinical development of emerging therapeutics.
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