Primary completion· ClinicalTrials.gov
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Mul
Fenebrutinib History and Updates
19 events · 2018 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
19
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Fenebrutinib since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (3)
2026
- Primary completionFenebrutinib Phase 3 Trial in Relapsing MS Reaches Primary Completion· Jan 27, 2026
2025
- Primary completionFenebrutinib Phase 3 Trial for Primary Progressive MS Reaches Primary Completion· Sep 17, 2025
- Primary completionFenebrutinib Phase 3 Trial in Relapsing MS Completes Primary Data Collection· Sep 5, 2025
Upcoming & expected milestones
Past events
2026
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
2025
Trial started· ClinicalTrials.gov
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Mul
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multipl
Trial registered· ClinicalTrials.gov
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Mul
Primary completion· ClinicalTrials.gov
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
2024
Results posted· ClinicalTrials.gov
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
2023
Primary completion· ClinicalTrials.gov
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
2022
Trial started· ClinicalTrials.gov
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
2021
Trial registered· ClinicalTrials.gov
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
Trial started· ClinicalTrials.gov
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Trial started· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
2020
Trial started· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multipl
Trial registered· ClinicalTrials.gov
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multipl
2018
Primary completion· ClinicalTrials.gov
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
Trial started· ClinicalTrials.gov
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
Trial registered· ClinicalTrials.gov
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
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.