
On March 24, 2026, a major breakthrough was achieved in the treatment of chronic spontaneous urticaria (CSU). Remibrutinib, a novel oral targeted drug, was officially dispensed its first prescription in China.
The first prescription was issued in Tianjin, China by Professor Zhang Litao to a 21-year-old young patient. Professor Zhao Zuotao stated that second-generation antihistamines are currently the first-line treatment. To put it vividly, conventional antihistamines are like mopping up leaked water downstream, which only act on histamine that has already been released and fail to address the root cause. In contrast, remibrutinib works by turning off the tap directly. It precisely inhibits the Bruton’s tyrosine kinase (BTK) signaling pathway, suppresses mast cell activation at the source, blocks the release of histamine and other pro-inflammatory mediators, and fundamentally prevents the onset of symptoms.
"The advantages of this small-molecule drug lie in its rapid efficacy. Many patients achieve rash control on the very first day of treatment. More importantly, it enables long-term disease control and sustains symptom relief for up to one consecutive year, freeing patients from recurrent itching and helping them restore a normal quality of life," Professor Zhao emphasized.
As the first approved oral small-molecule targeted agent for CSU, remibrutinib obtained rapid approval via the priority review pathway of the National Medical Products Administration (NMPA). The dispensing of its first prescription brings new hope to numerous patients stuck in treatment dilemmas.
Sep 30, 2025, Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU).
Remibrutinib
| Target: | BTK |
| Originator: | Novartis Pharma AG |
| Developers: | Novartis Pharmaceuticals Corp., Novartis Pharmaceuticals Canada, Inc., Novartis (China) Biomedical Research Co., Ltd. |
| Indications Under Development: | Chronic Spontaneous Urticaria, Myasthenia Gravis, Secondary Progressive Multiple Sclerosis |
| Highest R&D Phase: | Approved for Marketing |
| First Approval Date: | 2025-09-30 |
| First Approved Country/Region: | United States |
Remibrutinib Starting Materials and Intermediates
| Intermediates Name | CAS NO. |
| 4-Cyclopropyl-2-fluorobenzoic acid | 1247927-81-6 |
| 2-Bromo-4-fluoro-6-nitrotoluene | 502496-33-5 |
RELYBO is committed to providing global customers with high-purity, high-quality Remibrutinib intermediates with stable supply from kilogram to ton cales, accelerating the innovation and commercialization.
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