CENRIFKI (Tolebrutinib)

CENRIFKI (tolebrutinib), from Sanofi, is the first therapy approved in the EU specifically to slow disability in non-relapsing secondary progressive multiple sclerosis (nrSPMS) — adults with SPMS who have had no relapses in the past two years. The European Commission granted marketing authorisation on 19 June 2026.

Tolebrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor that crosses into the brain, where it targets the smouldering inflammation driven by microglia and B cells that fuels progression. In the Phase 3 HERCULES trial it reduced the risk of 6-month confirmed disability progression by 31% and new or enlarging T2 lesions by 38% versus placebo.

• Drug-induced liver injury is the most important risk. CENRIFKI must not be used in moderate or severe hepatic impairment or when baseline ALT/AST, alkaline phosphatase or bilirubin exceed set limits; liver tests must be monitored during treatment as per the EU product information.
• Raised liver enzymes are among the common side effects.
• The US FDA did not approve tolebrutinib; it is available only where authorised (EU).

What documents are required to import CENRIFKI to India?

CENRIFKI may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered neurologist
• Neurologist’s report confirming SPMS without relapses in the last 2 years, plus baseline liver function tests
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is CENRIFKI available in India?

CENRIFKI received EU approval in June 2026 and is not marketed in India. It can be legally accessed through the Named Patient Program (NPP), subject to applicable regulations.

Indian Pharma Network (IPN) can source CENRIFKI from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For CENRIFKI cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• European Union: Marketing authorisation — 19 June 2026 (CHMP positive opinion April 2026).
• United States: Not approved by the FDA.

What is CENRIFKI used for?

CENRIFKI (tolebrutinib) is an oral, brain-penetrant BTK inhibitor used for non-relapsing secondary progressive multiple sclerosis.

Who manufactures CENRIFKI?

CENRIFKI is from Sanofi.

How does CENRIFKI work?

Tolebrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor that crosses into the brain, where it targets the smouldering inflammation driven by microglia and B cells that fuels progression.

Is CENRIFKI for relapsing MS?

No. The EU approval is for secondary progressive MS without relapses in the previous two years.

Is CENRIFKI approved by the US FDA?

No. The FDA declined to approve tolebrutinib; it is authorised in the European Union.