Drugs / Gadobenate dimeglumine
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | MULTIHANCE MULTIPACK | — | 2012-07-06 – 2018-01-19 | fda.gov ↗ |
| Label expansion | US (FDA) | MULTIHANCE | — | 2010-03-17 | fda.gov ↗ |
| Approved | US (FDA) | MULTIHANCE | — | 2004-11-23 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00411931 | Sep 2006 → Dec 2007 | central nervous system disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02633501 | Jun 2016 → Jan 2018 | — | Guerbet | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT01260636 | Sep 2009 → Dec 2011 | arterial disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00486473 | Jul 2007 → Dec 2009 | breast cancer | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00415805 | Dec 2006 → Dec 2008 | arterial disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00408083 | Dec 2006 → Nov 2008 | peripheral vascular disease | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00323310 | Apr 2006 → Sep 2008 | central nervous system disorder | Bracco Diagnostics, Inc | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02070380 | Feb 2014 → Mar 2015 | brain disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00323102 | May 2006 → Mar 2007 | brain disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02967380 | Dec 2011 → Oct 2014 | adult anaplastic ependymoma, adult brain ependymoma, adult brainstem glioma, adult choroid plexus neoplasm +19 | University of Southern California | Terminated | No outcome recorded |
| — | NCT00539253 | Sep 2007 → Mar 2013 | hepatocellular carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT04910425 Background | Jun 2023 → Jun 2026 | prostate carcinoma | Northwestern University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03703492 Background | Jan 2019 → Jan 2024 | ductal breast carcinoma in situ | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 2 | NCT01710254 Background | Jan 2013 → Oct 2016 | atrial fibrillation, coronary artery disorder | University of Utah | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06406517 Comparator | May 2024 → Jun 2025 | congenital heart disease | University of California, San Diego | Unknown | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT00907530 Comparator | Sep 2009 → Mar 2011 | — | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00395863 Comparator | Nov 2006 → Feb 2008 | brain neoplasm | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04132843 Background | Jan 2020 → Sep 2022 | lymphoma, metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadobenate Dimeglumine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04910425 ↗ |
| Known as | MultiHance | “Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain” NCT00323102 ↗ |
| Modality | Diagnostic / imaging agent | “magnetic resonance imaging (MRI) contrast agent MultiHance” NCT00323310 ↗ |
| Route | Intravenous | “was injected intravenously” NCT00323310 ↗ |