The Zhitong Finance App learned that on September 3, the official website of the National Drug Administration (NMPA) showed that Sanofi (SNY.US) BTK inhibitor rizabutinib tablets were approved for marketing in adult patients with persistent or chronic primary immune thrombocytopenia (ITP) who have had poor response or intolerance to previous treatments such as glucocorticoids and immunoglobulins.
Rilzabrutinib (Rilzabrutinib) is an oral, reversible, covalent BTK inhibitor. In September 2020, Sanofi acquired Principia Biopharma for $3.68 billion, acquiring the latter's two BTK inhibitors, Rilzabrutinib and Tolebrutinib. In August 2025, Rilzabrutinib was approved by the FDA for marketing, becoming the first BTK inhibitor approved for ITP.
FDA approval is based on the positive results of the critical phase III clinical study LUNA 3. This is a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Rilzabrutinib versus placebo in adults and adolescents with persistent or chronic ITP who have previously been treated.
In addition to ITP indications, Sanofi is also exploring Rilzabrutinib's therapeutic potential for other immune diseases, including chronic spontaneous urticaria, IgG4-related diseases, and atopic dermatitis.
According to the Insight database, ibutinib, the world's first BTK inhibitor, was approved for marketing in November 2013. In the 10 years since approval, 9 other BTK inhibitors have been approved, but the indications are mainly in the field of cancer. As Sanofi's Rilzabrutinib and Novartis rimibutinib are approved as self-exempt indications in 2025, the commercial ceiling for BTK inhibitors will also be further broadened.