Tolebrutinib History and Updates

38 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
38
Trial Milestones
0
Pivotal Publications
Tolebrutinib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20192020202120222023202420252026202720282029Trial: NCT06372145 2024-04-16 → 2029-04-30 (primary completion)Trial: NCT05283915 2022-03-18 → 2022-05-24 (primary completion)Trial: NCT05282030 2022-03-10 → 2022-08-02 (primary completion)Trial: NCT04742400 2021-04-15 → 2023-06-15 (primary completion)Trial: NCT04411641 2020-09-24 → 2024-08-29 (primary completion)Trial: NCT04458051 2020-08-13 → 2025-11-14 (primary completion)Trial: NCT06106074 2020-08-10 → 2022-05-23 (primary completion)Trial: NCT04410978 2020-06-30 → 2024-07-15 (primary completion)Trial: NCT04410991 2020-06-11 → 2024-07-16 (primary completion)Trial: NCT06064539 2020-05-18 → 2020-07-08 (primary completion)Trial: NCT03996291 2019-09-23 → 2024-11-26 (primary completion)Results posted — 2024-08-13 Trial results posted: NCT04742400 Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in MultiResults posted — 2025-06-18 Trial results posted: NCT04410991 Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)Results posted — 2025-06-18 Trial results posted: NCT04410978 Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)Results posted — 2025-06-18 Trial results posted: NCT04411641 Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HResults posted — 2025-10-23 Trial results posted: NCT03996291 Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosistoday (2026-05-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Tolebrutinib since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (5)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06372145
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Past events

2025
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04458051
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Results posted· ClinicalTrials.gov
Trial results posted: NCT03996291
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Results posted· ClinicalTrials.gov
Trial results posted: NCT04410991
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Results posted· ClinicalTrials.gov
Trial results posted: NCT04410978
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Results posted· ClinicalTrials.gov
Trial results posted: NCT04411641
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (H
2024
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT03996291
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04411641
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (H
Results posted· ClinicalTrials.gov
Trial results posted: NCT04742400
Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multi
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04410991
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT04410978
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06372145
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
2023
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04742400
Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multi
2022
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05282030
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy P
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05283915
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Pa
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06106074
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05283915
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Mild Hepatic Impairment Compared to Pa
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05282030
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy P
2021
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04742400
Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multi
2020
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04411641
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (H
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04458051
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06106074
Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06064539
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04410978
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT04410991
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06064539
Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
2019
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT03996291
Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.