What Is Fenebrutinib?
Fenebrutinib is an investigational drug that is administered orally. While the specific way fenebrutinib works in the body is not detailed in the provided trial descriptions, it is being investigated for its potential to treat certain conditions. Research is primarily focused on its use for Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis. A total of six clinical trials have been conducted or are currently underway for fenebrutinib. These studies have involved a total of 2,611 participants. One trial is currently recruiting new participants, and one trial has been completed. The first clinical trial for fenebrutinib began in 2018, and the latest trial is projected to conclude in 2025. All studies for fenebrutinib are sponsored by Hoffmann-La Roche, an industry sponsor. As an investigational drug, fenebrutinib is not yet approved for any medical conditions.Uses and Conditions Under Study
Fenebrutinib is currently being investigated in clinical trials for its potential to treat multiple sclerosis, a chronic disease where the immune system attacks the protective covering of nerve fibers in the brain and spinal cord.- Relapsing Multiple Sclerosis (RMS): This form of MS involves periods of new or worsening symptoms (relapses) followed by periods of recovery. Four clinical trials are investigating fenebrutinib as a potential treatment for Relapsing Multiple Sclerosis. The drug is being studied to see if it can help manage the disease activity and reduce the frequency or severity of relapses.
- Primary Progressive Multiple Sclerosis (PPMS): This form of MS is characterized by a gradual worsening of neurological function from the onset, without distinct relapses or remissions. One clinical trial is studying fenebrutinib for Primary Progressive Multiple Sclerosis, exploring its potential to slow disease progression.
Dosing
Fenebrutinib is an investigational drug that is administered orally. Clinical trials have explored different oral forms of the drug. One specific dosage form studied is a single oral solution dose. This solution was used in a trial to understand how the drug is processed by the body. One trial description explicitly mentions a 200-mg oral solution of fenebrutinib, which included a radiolabeled component (100 µCi 14C/12C-fenebrutinib) to track its absorption and metabolism. While other specific strengths or forms like tablets or capsules are not detailed in the trial descriptions, the general mention of "Fenebrutinib" as a studied dosage form implies other oral preparations may be under investigation. The precise dosing schedules, including how often fenebrutinib is taken or whether it should be taken with or without food, are determined by the specific clinical trial protocols. These details are not provided in this general overview. As fenebrutinib is still an investigational drug, standard adult or pediatric doses have not yet been established or approved.Side Effects
In a clinical trial involving patients taking Fenebrutinib, the most common side effect reported was abnormal hepatic (liver) enzyme levels. This occurred in 5.5% of patients receiving Fenebrutinib, compared to 0.0% of patients who received a placebo.
Another reported side effect was urinary tract infection, which affected 5.5% of patients taking Fenebrutinib and 5.6% of patients on placebo. This indicates that urinary tract infections occurred at a similar rate in both the Fenebrutinib and placebo groups.
Clinical Trial Results
Fenebrutinib for Relapsing Multiple Sclerosis (RMS)
A clinical trial (NCT05119569) investigated the efficacy of Fenebrutinib in patients with Relapsing Multiple Sclerosis (RMS) over a 12-week period. The study primarily focused on reducing the number of new or enlarging lesions in the brain, as observed on MRI scans.
Participants treated with Fenebrutinib showed a significant reduction in new brain lesions compared to those on placebo. Over 12 weeks, the average number of new gadolinium (Gd)-enhancing T1 lesions was 0.077 for Fenebrutinib-treated patients, compared to 0.245 for those on placebo. Similarly, the average number of new or enlarging T2-weighted lesions over 12 weeks was 0.168 for patients taking Fenebrutinib, versus 0.634 for patients on placebo.
Furthermore, Fenebrutinib demonstrated a higher proportion of patients who were free from any new lesions. Over the 12-week study, 72.9% of participants receiving Fenebrutinib had no new Gd-enhancing T1 lesions or new or enlarging T2-weighted lesions, compared to 50.0% of participants in the placebo group.
Currently Recruiting Trials
Clinical trials are essential for evaluating new treatments, and Fenebrutinib is currently being investigated in studies designed to understand its potential benefits and safety. If you are considering participating in a clinical trial, understanding the specific goals and eligibility criteria is an important first step.
One ongoing study, NCT07161258, is a Phase 2 trial investigating Fenebrutinib in children and adolescents with Relapsing Multiple Sclerosis (RMS). This open-label, single-arm study, sponsored by Hoffmann-La Roche, aims to understand how Fenebrutinib is processed by the body (pharmacokinetics) and its effects (pharmacodynamics), as well as its safety and tolerability. The study is designed for participants aged between 10 and less than 18 years old, with an enrollment target of 12 individuals. It includes a Dose Exploration Period and an Optional Extension Period, allowing eligible participants to continue treatment if they choose.
Where to Participate
Currently, the recruiting trial for Fenebrutinib in pediatric Relapsing Multiple Sclerosis, NCT07161258, does not yet list specific study sites. This means that while the trial is actively seeking participants, the locations where it will be conducted have not been publicly disclosed. The study is open to both male and female participants aged between 10 and 17 years. It is specifically designed for children and adolescents with Relapsing Multiple Sclerosis and does not enroll healthy volunteers.
Development Timeline
The journey of Fenebrutinib in clinical development began on July 24, 2018, with its first clinical trial. Since then, Hoffmann-La Roche has been the sole sponsor, driving all six clinical trials for this investigational drug. Initially, Fenebrutinib was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline expanded significantly, shifting focus to neurological conditions.
The program now includes studies for Multiple Sclerosis, including Primary Progressive Multiple Sclerosis. The development has progressed through various stages, starting with one Phase 1 trial, moving into two Phase 2 trials, and currently featuring three Phase 3 trials, indicating advanced stages of investigation. The latest trial is projected to conclude by September 8, 2025, reflecting a comprehensive and ongoing commitment to understanding Fenebrutinib's potential. Across all trials, a total of 2,611 participants have been involved in its study.