Tolebrutinib

Tolebrutinib
Clinical data
Trade names	Cenrifki
Other names	PRN-2246; SAR-442168
Routes of; administration	By mouth
Drug class	Bruton's tyrosine kinase inhibitor
ATC code	L04AA62 (WHO) ;
Legal status
Legal status	EU: Rx-only;
Identifiers
	IUPAC name 4-amino-3-(4-phenoxyphenyl)-1-[(3R)-1-prop-2-enoylpiperidin-3-yl]imidazo[4,5-c]pyridin-2-one;
CAS Number	1971920-73-6;
PubChem CID	124111565;
DrugBank	DB18715;
ChemSpider	88298633;
UNII	8CZ82ZYY9X;
KEGG	D12213;
ChEMBL	ChEMBL4650323;
Chemical and physical data
Formula	C26H25N5O3
Molar mass	455.518 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES C=CC(=O)N1CCC[C@H](C1)N2C3=C(C(=NC=C3)N)N(C2=O)C4=CC=C(C=C4)OC5=CC=CC=C5;
	InChI InChI=1S/C26H25N5O3/c1-2-23(32)29-16-6-7-19(17-29)30-22-14-15-28-25(27)24(22)31(26(30)33)18-10-12-21(13-11-18)34-20-8-4-3-5-9-20/h2-5,8-15,19H,1,6-7,16-17H2,(H2,27,28)/t19-/m1/s1; Key:KOEUOFPEZFUWRF-LJQANCHMSA-N;

Tolebrutinib, sold under the brand name Cenrifki, is a medication used for the treatment of multiple sclerosis.^[1] It is a Bruton's tyrosine kinase inhibitor.^[1]^[3] It is taken by mouth.^[1]

Tolebrutinib was authorized for medical use in the European Union in June 2026.^[1]^[2]

Medical uses

Tolebrutinib is indicated for the treatment of adults with secondary progressive multiple sclerosis without relapses in the last two years.^[1]

Society and culture

Legal status

In April 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cenrifki, intended for the treatment of multiple sclerosis.^[1] The applicant for this medicinal product is Sanofi Winthrop Industrie.^[1] Tolebrutinib was authorized for medical use in the European Union in June 2026.^[1]^[2]

Names

Tolebrutinib is the international nonproprietary name.^[4]

Tolebrutinib is sold under the brand name Cenrifki.^[5]

References

1 2 3 4 5 6 7 8 9 "Cenrifki EPAR". European Medicines Agency (EMA). 24 April 2026. Retrieved 28 May 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
1 2 3 "Cenrifki PI". Union Register of medicinal products. 22 June 2026. Retrieved 12 July 2026.
↑ Turner TJ, Brun P, Gruber RC, Ofengeim D (June 2024). "Comparative CNS Pharmacology of the Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib Versus Other BTK Inhibitor Candidates for Treating Multiple Sclerosis". Drugs in R&D. 24 (2): 263–274. doi:10.1007/s40268-024-00468-4. PMC 11315827. PMID 38965189.
↑ World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.
↑ "Press Release: Sanofi's Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses" (Press release). Sanofi. 23 June 2026. Retrieved 12 July 2026.

External links

"Tolebrutinib ( Code - C173549 )". EVS Explore.

[Cenrifki_EPAR-1] 1 2 3 4 5 6 7 8 9 "Cenrifki EPAR". European Medicines Agency (EMA). 24 April 2026. Retrieved 28 May 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

[Cenrifki_PI-2] 1 2 3 "Cenrifki PI". Union Register of medicinal products. 22 June 2026. Retrieved 12 July 2026.

[Turner_2024-3] Turner TJ, Brun P, Gruber RC, Ofengeim D (June 2024). "Comparative CNS Pharmacology of the Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib Versus Other BTK Inhibitor Candidates for Treating Multiple Sclerosis". Drugs in R&D. 24 (2): 263–274. doi:10.1007/s40268-024-00468-4. PMC 11315827. PMID 38965189.

[4] World Health Organization (2020). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 84". WHO Drug Information. 34 (3). hdl:10665/340680.

[5] "Press Release: Sanofi's Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses" (Press release). Sanofi. 23 June 2026. Retrieved 12 July 2026.

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