Fenebrutinib

Overview

Fenebrutinib is under investigation in clinical trial NCT03174041 (A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity	2025/05/11	NCT06965413	Phase 2	Recruiting	Hoffmann-La Roche
A Study to Evaluate RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy	2022/09/21	NCT05548556	Phase 2	Active, not recruiting	Hoffmann-La Roche
A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)	2021/11/15	NCT05119569	Phase 2	Active, not recruiting	Hoffmann-La Roche
A Study to Investigate the Safety and Efficacy of RO7204239 in Combination With Risdiplam (RO7034067) in Participants With Spinal Muscular Atrophy	2021/11/10	NCT05115110	Phase 2	Active, not recruiting	Hoffmann-La Roche
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)	2020/10/14	NCT04586023	Phase 3	Active, not recruiting	Hoffmann-La Roche
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)	2020/10/14	NCT04586010	Phase 3	Active, not recruiting	Hoffmann-La Roche
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis	2020/09/10	NCT04544449	Phase 3	Active, not recruiting	Hoffmann-La Roche
A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study	2018/10/03	NCT03693625	Phase 2	Terminated	Genentech, Inc.
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers	2018/07/24	NCT03596632	Phase 1	Completed	Hoffmann-La Roche
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus	2018/01/23	NCT03407482	Phase 2	Terminated	Genentech, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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