Drugs / Fenebrutinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | multiple sclerosis | 2026-09-29 | “Genentech’s Fenebrutinib Is the First BTK Inhibitor to Receive U.S. FDA Filing Acceptance in Both Relapsing and Primary Progressive Multiple Sclerosis” gene.com ↗ “the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib” roche.com ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03596632 | Jul → Aug 2018 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03290703 | Apr 2017 → Oct 2018 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03174041 | Apr → Jun 2017 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03188783 | Jan → Aug 2017 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02699710 | Sep 2015 → May 2016 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01991184 | Dec 2013 → Mar 2022 | diffuse large B-cell lymphoma | Genentech, Inc. | Completed | No outcome recorded |
| Phase 28 trials · 3 met primary · 1 missed | ||||||
| Phase 2 | NCT07161258 | Oct 2025 → Jun 2027 expected | multiple sclerosis | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT05119569 | Mar 2022 → Mar 2023 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 2 | NCT03693625 | Sep 2018 → Oct 2019 | urticaria | Genentech, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03407482 | Jan 2018 → Nov 2019 | systemic lupus erythematosus | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT03137069 | May 2017 → Sep 2019 | chronic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2 | NCT02908100 | Jan 2017 → May 2019 | systemic lupus erythematosus | Genentech, Inc. | Completed | Missed primary |
| Phase 2 | NCT02983227 | Nov 2016 → Jul 2019 | rheumatoid arthritis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02833350 | Sep 2016 → Jul 2018 | rheumatoid arthritis | Genentech, Inc. | Completed | Met primary |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04586023 | Mar 2021 → Sep 2025 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04586010 | Mar 2021 → Jan 2026 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04544449 | Oct 2020 → Sep 2025 overdue | primary progressive multiple sclerosis | Hoffmann-La Roche | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-09-30 | Hoffmann-La Roche | Regulatory Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis roche.com ↗ |
| 2026-09-29 | Genentech, Inc. | Regulatory Genentech’s Fenebrutinib Is the First BTK Inhibitor to Receive U.S. FDA Filing Acceptance in Both Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). |
| 2026-04-21 | Hoffmann-La Roche | Results Roche’s fenebrutinib significantly reduced relapses versus standard of care to approximately one every 17 years in RMS roche.com ↗
Late-breaking Phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in relapsing multiple sclerosis (RMS) |
| 2026-04-21 | Genentech, Inc. | Results Genentech’s Fenebrutinib Significantly Reduced Relapses Versus Standard of Care to Approximately One Every 17 Years in RMS gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today new data from the positive Phase III FENhance 1 and 2 studies, which met their primary endpoint. |
| 2026-03-02 | Hoffmann-La Roche | Results [Ad hoc announcement pursuant to Art. 53 LR] Roche's fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive MS in third positive Phase III study (FENhance 1) roche.com ↗
FENhance 1 met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in relapsing multiple sclerosis (RMS), consistent with FENhance 2 results showing 59% reduction |
| 2026-03-01 | Genentech, Inc. | Results Genentech's Fenebrutinib Confirms Its Potential as First and Only BTK Inhibitor for Relapsing and Primary Progressive MS in Third Positive Phase III Study (FENhance 1) gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the pivotal Phase III study (FENhance 1) of fenebrutinib in RMS met its primary endpoint, showing clinically meaningful and statistically significant results. |
| 2026-02-07 | Hoffmann-La Roche | Results Roche’s fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS) roche.com ↗
Late-breaking Phase III FENtrepid results presented at ACTRIMS show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, OCREVUS, in reducing disability progression in PPMS |
| 2026-02-07 | Genentech, Inc. | Results Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS) gene.com ↗
Late-breaking Phase III FENtrepid results presented at ACTRIMS show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, Ocrevus, in reducing disability progression in PPMS |
| 2025-11-10 | Hoffmann-La Roche | Results [Ad hoc announcement pursuant to Art. 53 LR] Roche’s fenebrutinib shows unprecedented positive Phase III results as the potential first and only BTK inhibitor in both relapsing and primary progressive multiple sclerosis roche.com ↗
The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. |
| 2025-11-09 | Genentech, Inc. | Results Genentech’s Fenebrutinib Shows Unprecedented Positive Phase III Results as the Potential First and Only BTK Inhibitor in Both Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗
The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. |
| 2025-09-24 | Hoffmann-La Roche | Results Roche presents new data for OCREVUS and fenebrutinib across broad patient populations at ECTRIMS 2025 roche.com ↗
Fenebrutinib two-year Phase II data demonstrate near-complete suppression of disease activity at 96 weeks |
| 2025-09-23 | Genentech, Inc. | Results Genentech Presents New Data for Ocrevus and Fenebrutinib Across Broad Patient Populations at ECTRIMS 2025 gene.com ↗
Fenebrutinib two-year Phase II data demonstrate near-complete suppression of disease activity at 96 weeks |
| 2025-05-30 | Hoffmann-La Roche | Results Roche’s fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, 96-week data for fenebrutinib demonstrating that patients with relapsing multiple sclerosis (RMS) maintained no disability progression and low levels of disease activity for up to two years. |
| 2025-05-29 | Genentech, Inc. | Results Genentech’s Fenebrutinib Maintains Near-Complete Suppression of Disease Activity and Disability Progression for up to Two Years in People With Relapsing Multiple Sclerosis gene.com ↗
These data show that patients treated with fenebrutinib experienced an annualized relapse rate equal to one relapse every 17 years and no observed disability progression up to two years |
| 2024-09-04 | Hoffmann-La Roche | Results Roche’s fenebrutinib demonstrated near-complete suppression of disease activity and disability progression for up to 48 weeks in patients with relapsing multiple sclerosis roche.com ↗
During the OLE period, 96% of patients treated with fenebrutinib were free of relapses at one year, with an annualised relapse rate (ARR) of 0.04, and no change in disability over 48 weeks as measured by the Expanded Disability Status Scale (EDSS). |
| 2023-10-13 | Hoffmann-La Roche | Results Late-breaking data for Roche’s BTK inhibitor fenebrutinib show brain penetration and significant reduction in lesions in patients with relapsing multiple sclerosis roche.com ↗
More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at 8 weeks |
| 2023-10-13 | Genentech, Inc. | Results Late-Breaking Data for Genentech’s BTK Inhibitor Fenebrutinib Show Brain Penetration and Significant Reduction in Lesions in Patients With Relapsing Multiple Sclerosis gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new data from the Phase II FENopta study showing that investigational, oral fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis (RMS), with a consistent safety profile to other fenebrutinib trials. |
| 2023-05-17 | Hoffmann-La Roche | Results Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis roche.com ↗
The study met its primary and secondary endpoints, showing oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo. |
| 2023-05-16 | Genentech, Inc. | Results Genentech’s BTK Inhibitor Fenebrutinib Significantly Reduced Brain Lesions in People With Relapsing Forms of Multiple Sclerosis gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase II FENopta study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS). |
| 2021-10-04 | Genentech, Inc. | Results Genentech to Present New Data on Ocrevus (ocrelizumab) in Multiple Sclerosis and Enspryng (satralizumab-mwge) in Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2021 gene.com ↗
Fenebrutinib Reduces Disease Activity in a Mouse Model of Inflammatory Multiple Sclerosis, which is Associated with Reduced Microglial Activation |
| 2021-04-08 | Hoffmann-La Roche | Results New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio roche.com ↗
Data for investigational MS medicine fenebrutinib support its safety profile and high potency |
| 2021-04-07 | Genentech, Inc. | Results New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio gene.com ↗
Data for investigational MS medicine fenebrutinib support its safety profile and high potency |
All press releases naming this drug 24 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fenebrutinib | “Fenebrutinib (GDC-0853) is a noncovalent, oral, and highly selective inhibitor of Bruton's tyrosine kinase (BTK).” PMID 34042314 ↗ Aug 2021 |
| Known as | G-02599853 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4065122 ↗ |
| Known as | GDC-0853 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03290703 ↗ |
| Known as | RG-7845 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4065122 ↗ |
| Known as | RO-7010939 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4065122 ↗ |
| Action | Inhibit | “inhibitor of Bruton's tyrosine kinase (BTK)” PMID 34042314 ↗ Aug 2021 |
| Modality | Small molecule | — CHEMBL4065122 ↗ |
| Route | Oral | “administered orally” NCT02699710 ↗ |
| Target | BTK | “inhibitor of Bruton's tyrosine kinase (BTK)” PMID 34042314 ↗ Aug 2021 |