Swapnroop Drugs & Pharmaceuticals is a pharmaceutical API manufacturer and supplier of Tolebrutinib, a selective, orally active and CNS-penetrant Bruton’s tyrosine kinase (BTK) inhibitor. Tolebrutinib is also known by the development names SAR442168 and PRN2246. The active substance has the molecular formula C₂₆H₂₅N₅O₃ and a relative molecular mass of 455.52 g/mol.
Tolebrutinib is a small-molecule BTK inhibitor designed to penetrate the blood-brain barrier and inhibit BTK activity in B cells and CNS-resident immune cells such as microglia. In 2026, the European Medicines Agency authorised Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis without relapses during the previous two years.
Tolebrutinib is chemically identified as 4-amino-3-(4-phenoxyphenyl)-1-[(3R)-1-(prop-2-enoyl)piperidin-3-yl]-1,3-dihydro-2H-imidazo[4,5-c]pyridin-2-one. It contains one stereogenic centre and the active substance is present in the (R) configuration. EMA quality documentation describes the API as a white to beige, non-hygroscopic powder with poor aqueous solubility and pH-dependent solubility.
The API is associated with the following identifiers:
Tolebrutinib is a selective BTK inhibitor investigated and developed for neurological and immune-mediated disorders, particularly multiple sclerosis. Its ability to penetrate the central nervous system is an important characteristic because BTK signalling is involved not only in peripheral B-cell activity but also in CNS immune-cell pathways.
The currently authorised EU medicine Cenrifki contains tolebrutinib as the active substance and is indicated for adult patients with secondary progressive multiple sclerosis without relapses in the previous two years.
Swapnroop supports pharmaceutical companies, formulation developers and qualified procurement organisations requiring Tolebrutinib API for pharmaceutical development and manufacturing applications.
Supply can be supported with appropriate pharmaceutical documentation and quality information, subject to the applicable product specification and regulatory requirements.
The EMA assessment confirms that the commercial active-substance manufacturing process involves six main synthetic steps, with controls covering starting materials, intermediates, process parameters and the final active substance. The active substance specification includes controls for appearance, identification, assay, related impurities, residual solvents, polymorphism, residue on ignition, water content and microbiological quality.
Tolebrutinib should be packaged in a suitable pharmaceutical-grade container closure system that protects the active substance from environmental exposure. EMA documentation states that the active substance is packaged in a container closure compliant with applicable EU food-contact-material requirements.
Storage conditions should follow the approved product specification and stability data supplied with the API.
Swapnroop Drugs & Pharmaceuticals provides Tolebrutinib API for qualified pharmaceutical and research requirements, subject to applicable regulatory and commercial conditions.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |