Drugs / Gantenerumab
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03236844 | Aug → Dec 2017 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02882009 | Aug 2016 → Mar 2017 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02711423 | Mar → Sep 2016 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01656525 | Jun 2012 → Mar 2014 | Alzheimer disease | Chugai Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT00531804 | Dec 2006 → Sep 2010 | Alzheimer disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04592341 | Nov 2020 → Jan 2023 | Alzheimer disease | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06424236 | Jun 2020 → Oct 2023 | early-onset autosomal dominant Alzheimer disease | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2/3 | NCT04623242 | Dec 2012 → Nov 2019 | familial Alzheimer disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 37 trials · 3 missed | ||||||
| Phase 3 | NCT05256134 | Apr 2022 → Mar 2023 | Alzheimer disease | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT04374253 | Jan 2021 → Mar 2023 | Alzheimer disease | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT04339413 | May 2020 → Jan 2023 | Alzheimer disease | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT03443973 | Aug 2018 → Sep 2022 | Alzheimer disease | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT03444870 | Jun 2018 → Dec 2022 | Alzheimer disease | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 3 | NCT02051608 | Mar 2014 → Apr 2021 | Alzheimer disease | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01224106 | Nov 2010 → Sep 2020 | Alzheimer disease | Hoffmann-La Roche | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT02133937 Comparator | Apr → Sep 2014 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01636531 Comparator | May → Oct 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2/3 | NCT01760005 Comparator | Dec 2012 → Apr 2028 expected | familial Alzheimer disease | Washington University School of Medicine | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-11-14 | Hoffmann-La Roche | Results [Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on Phase III GRADUATE programme evaluating gantenerumab in early Alzheimer’s disease roche.com ↗
The studies did not meet their primary endpoint of slowing clinical decline. |
| 2021-10-08 | Hoffmann-La Roche | Regulatory [Ad hoc announcement pursuant to Art. 53 LR] Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease roche.com ↗ |
| 2020-02-10 | Hoffmann-La Roche | Results Roche provides topline results from investigator-led Phase II/III trial with gantenerumab in rare inherited form of Alzheimer’s disease roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 study did not meet its primary endpoint in people who have an early-onset, inherited form of Alzheimer’s disease (AD). |
| 2019-04-29 | Hoffmann-La Roche | Results New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio roche.com ↗
Data and safety findings from the gantenerumab SCarlet RoAD and Marguerite RoAD open-label extension studies will be presented that show consistently large amyloid reductions in AD patients with and without ARIA-E. |
| 2018-04-16 | Hoffmann-La Roche | Results Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline roche.com ↗
In a platform session, data on gantenerumab will be presented showing a significant reduction in brain amyloid beta plaques with a higher dosing regimen (1200mg) in two Phase III, open label extension studies. |
All press releases naming this drug 5 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gantenerumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01760005 ↗ |
| Known as | R-04909832 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743025 ↗ |
| Known as | R-1450 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743025 ↗ |
| Known as | RG-1450 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743025 ↗ |
| Known as | RO-4909832 R-1450 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743025 ↗ |
| Known as | RO4909832 | “This multi-center, randomized, double-blind, placebo-controlled parallel-group study will evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the...” NCT01224106 ↗1“a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers” NCT01636531 ↗ |
| Action | Inhibit | “Gantenerumab reduced amyloid PET load” PMID 39887500 ↗ Jan 2025 |
| Modality | Monoclonal antibody | “immunoglobulin G1 monoclonal antibody” PMID 39177596 ↗ 2024 |
| Route | Intravenous | “Administered iv at escalating doses (7 cohorts)” NCT00531804 ↗ |
| Target | APP | “Amyloid-beta A4 protein binding agent” CHEMBL1743025 ↗ |