Product Description
Gantenerumab (RG1450) is a fully human monoclonal antibody that binds and neutralises disease-relevant aggregated forms of amyloid-beta: those that accumulate as plaques in the brain and those which interfere with brain-cell functioning. A phase III clinical trial is evaluating gantenerumab for the treatment of Alzheimer's disease. (Sourced from: https://www.roche.com/solutions/pipeline/#f24b5f67-0000-422b-b6a0-68b7d67a513d)
Mechanisms of Action: AB Binder
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: Breakthrough Therapy - Alzheimer Disease *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Roche
Company Location:
Company CEO:
Additonal Commercial Interests: MorphoSys AG
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Canada, Chile, China, Croatia, Denmark, Finland, Hungary, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, Russia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Alzheimer Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031220468 | P3 |
Not yet recruiting |
Alzheimer Disease |
2028-10-13 |
|
| 2021-001184-25 | P3 |
Active, not recruiting |
Alzheimer Disease |
2028-06-26 |
|
| jRCT2031200328 | P3 |
Active, not recruiting |
Alzheimer Disease |
2026-12-26 |
|
| 2020-000766-42 | P3 |
Unknown status |
Alzheimer Disease |
2024-12-23 |