Drugs / Tolebrutinib
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed secondary progressive multiple sclerosis 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | secondary progressive multiple sclerosis | 2025-12-24 | “FDA has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis” sanofi.com ↗ |
| Filed | US (FDA) | — | secondary progressive multiple sclerosis | 2025-03-25 | “Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis” sanofi.com ↗ |
| Filed | EU (EMA) | — | secondary progressive multiple sclerosis | — | “regulatory submission dossier is under review in the EU with a decision expected in Q1 2026” sanofi.com ↗ |
| Clinical hold myasthenia, limb-girdle, autoimmune 1 milestone | |||||
| Clinical hold | US (FDA) | — | myasthenia, limb-girdle, autoimmune | 2022-06-30 | “The U.S. Food and Drug Administration (FDA) has placed Phase 3 studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis on partial clinical hold.” sanofi.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Cenrifki | — | 2026-06-19 | europa.eu ↗ |
Trials 14
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 36 trials · 1 met primary · 3 missed | ||||||
| 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 Stop: Business |
| Phase 3 | NCT04411641 | Sep 2020 → Aug 2024 | secondary progressive multiple sclerosis | Sanofi | Completed | Met primary |
| Phase 3 | NCT04458051 | Aug 2020 → Nov 2025 | primary progressive multiple sclerosis | Sanofi | Completed | Missed primary |
| Phase 3 | NCT04410978 | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | Missed primary |
| Phase 3 | NCT04410991 | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | Sanofi | Regulatory 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 ↗
The European Commission has approved Cenrifki (tolebrutinib) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. |
| 2026-04-24 | Sanofi | Regulatory Press Release: Sanofi’s Cenrifki (tolebrutinib) recommended for EU approval by the CHMP to treat secondary progressive multiple sclerosis without relapses sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Cenrifki (tolebrutinib) in the EU for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. |
| 2025-12-24 | Sanofi | Regulatory Press Release: Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis sanofi.com ↗
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the new drug application of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) in adult patients. |
| 2025-12-15 | Sanofi | Results Press Release: Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis sanofi.com ↗
PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to onset of 6-month composite confirmed disability progression compared to placebo |
| 2025-12-15 | Sanofi | Regulatory Press Release : Sanofi provides update on tolebrutinib regulatory submission in non-relapsing secondary progressive multiple sclerosis sanofi.com ↗
Ongoing discussions with the FDA regarding nrSPMS application have indicated regulatory decision for tolebrutinib is anticipated to be delayed |
| 2025-09-22 | Sanofi | Regulatory Press Release: Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis sanofi.com ↗
The revised target action date for the FDA decision is December 28, 2025. |
| 2025-04-08 | Sanofi | Results Press Release: Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis sanofi.com ↗
The New England Journal of Medicine (NEJM) published positive results from the HERCULES phase 3 study demonstrating that tolebrutinib delayed disability progression in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS), where there are currently no treatment options approved. |
| 2025-03-25 | Sanofi | Regulatory Press Release: Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis sanofi.com ↗
The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. |
| 2024-12-13 | Sanofi | Regulatory Press Release: Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis sanofi.com ↗
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). |
| 2024-09-20 | Sanofi | Results 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 ↗
Positive results from the HERCULES phase 3 study in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS) demonstrated that tolebrutinib delayed the time to onset of 6-month confirmed disability progression (CDP) by 31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026). |
| 2024-09-02 | Sanofi | Results 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 ↗ |
| 2023-10-02 | Sanofi | Results Media Update: Sanofi presents new data from robust MS clinical pipeline exploring multiple approaches to address important unmet patient needs sanofi.com ↗
New findings from brain-penetrant and bioactive tolebrutinib, the company’s potentially best-in-disease oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, reinforce the ability of this near-term candidate to reach the central nervous system (CNS) to target smoldering neuroinflammation at its source. |
| 2023-02-23 | Sanofi | Results 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 ↗
New data for tolebrutinib, Sanofi’s investigational oral Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of multiple sclerosis (MS), showed a significant effect on key immune mediators that may drive disease progression within the CNS. |
| 2022-08-08 | Sanofi | Regulatory Media Update: Tolebrutinib clinical trial program update sanofi.com ↗
This past week, following the FDA’s decision to issue a partial clinical hold for Phase 3 studies of tolebrutinib, the independent data monitoring committee (iDMC) overseeing the clinical trials recommended that all studies should pause recruitment globally. |
| 2022-06-30 | Sanofi | Regulatory Media Update: Patient enrollment of phase III tolebrutinib trials paused in the U.S. sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has placed Phase 3 studies of tolebrutinib in multiple sclerosis (MS) and myasthenia gravis on partial clinical hold. |
| 2022-02-24 | Sanofi | Results New preclinical tolebrutinib data demonstrated superior brain penetration and potency sanofi.com ↗
In experiments using well-established preclinical methods, tolebrutinib was shown to be more potent than evobrutinib (50x) and fenebrutinib (9.3x), resulting in durable BTK inhibition. |
| 2021-10-13 | Sanofi | Results New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021 sanofi.com ↗
The results showed that after 48 weeks of treatment, tolebrutinib reduced multiple sclerosis (MS) disease activity as measured by magnetic resonance imaging (MRI). |
| 2020-04-23 | Sanofi | Results Press Release: Sanofi brain-penetrant BTK inhibitor significantly reduced disease activity in Phase 2 trial in relapsing multiple sclerosis sanofi.com ↗
Sanofi’s investigational BTK (Bruton's tyrosine kinase) inhibitor, an oral, brain-penetrant, selective small molecule achieved both the primary and secondary endpoints in a Phase 2b trial evaluating efficacy and safety in participants with relapsing forms of multiple sclerosis. |
| 2020-02-06 | Sanofi | Results Sanofi : Sanofi brain-penetrant BTK inhibitor meets primary endpoint of Phase 2 trial in relapsing multiple sclerosis sanofi.com ↗
The Sanofi Phase 2b study evaluating its investigational BTK (Bruton's tyrosine kinase) inhibitor (SAR442168), an oral, brain-penetrant, selective small molecule, achieved its primary endpoint. |
All press releases naming this drug 20 releases
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” NCT05283915 ↗ “Single dose of tolebrutinib (SAR442168) will be administered on Day 1 under fed condition” NCT05282030 ↗ |
| 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 |