Drugs / Tolebrutinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cenrifki | — | 2026-06-19 | europa.eu ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05283915 | Mar → May 2022 | liver disorder | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05282030 | Mar → Aug 2022 | impaired renal function disease | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT06106074 | Aug 2020 → May 2022 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT06064539 | May → Jul 2020 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT04171310 | Nov → Dec 2019 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04742400 | Apr 2021 → Jun 2023 | multiple sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Unknown | No outcome recorded |
| Phase 2 | NCT03996291 | Sep 2019 → Nov 2024 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT03889639 | Mar 2019 → Jan 2020 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06372145 | Apr 2024 → Apr 2029 expected | progressive relapsing multiple sclerosis, secondary progressive multiple sclerosis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05132569 | Dec 2021 → Feb 2023 | generalized myasthenia gravis | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT04411641 | Sep 2020 → Aug 2024 | secondary progressive multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04458051 | Aug 2020 → Nov 2025 | primary progressive multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04410978 | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04410991 | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
Press releases naming this drug 17 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | Sanofi | Press Release: Sanofi’s Cenrifki (tolebrutinib) approved in the EU as the first disability-targeting medicine for secondary progressive multiple sclerosis without relapses sanofi.com ↗ |
| 2026-04-24 | Sanofi | Press Release: Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses sanofi.com ↗ |
| 2025-12-24 | Sanofi | Press Release: Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis sanofi.com ↗ |
| 2025-12-15 | Sanofi | Press Release: Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis sanofi.com ↗ |
| 2025-12-15 | Sanofi | Press Release : Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis sanofi.com ↗ |
| 2025-09-22 | Sanofi | Press Release: Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis sanofi.com ↗ |
| 2025-04-08 | Sanofi | Press Release: Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis sanofi.com ↗ |
| 2025-03-25 | Sanofi | Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis sanofi.com ↗ |
| 2024-12-13 | Sanofi | Press Release: Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis sanofi.com ↗ |
| 2024-09-20 | Sanofi | Press Release: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study sanofi.com ↗ |
| 2024-09-02 | Sanofi | Press Release: Tolebrutinib meets primary endpoint in HERCULES phase 3 study, the first and only to show reduction in disability accumulation in non-relapsing secondary progressive multiple sclerosis sanofi.com ↗ |
| 2023-02-23 | Sanofi | Media Update: New data for tolebrutinib, Sanofi’s investigational brain- penetrant BTK inhibitor, showed significant effect on CNS immune mediators that drive MS disease progression sanofi.com ↗ |
| 2022-10-26 | Sanofi | Media Update: New two-year efficacy and safety data for tolebrutinib, Sanofi’s investigational, brain-penetrant and bioactive BTK inhibitor, to be presented at ECTRIMS 2022 sanofi.com ↗ |
| 2022-08-08 | Sanofi | Media Update: Tolebrutinib clinical trial program update sanofi.com ↗ |
| 2022-06-30 | Sanofi | Media Update: Patient enrollment of phase III tolebrutinib trials paused in the U.S. sanofi.com ↗ |
| 2022-02-24 | Sanofi | New preclinical tolebrutinib data demonstrated superior brain penetration and potency sanofi.com ↗ |
| 2021-10-13 | Sanofi | New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 sanofi.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tolebrutinib | “Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis” NCT05132569 ↗ |
| Known as | PRN-2246 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650323 ↗ |
| Known as | SAR442168 | “Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis” NCT05132569 ↗4“Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition” NCT05282030 ↗ “Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition” NCT05283915 ↗ |
| Action | Inhibit | “irreversible inhibitor of Bruton's tyrosine kinase” PMID 34418400 ↗ Sep 2021 |
| Modality | Small molecule | — CHEMBL4650323 ↗ |
| Route | Oral | “Pharmaceutical form: Film coated tablet; Route of administration: Oral” NCT03889639 ↗ |
| Target | BTK | “inhibitor of Bruton's tyrosine kinase” PMID 34418400 ↗ Sep 2021 |