Drugs / Gadoteridol
Gadoteridol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PROHANCE | — | 1994-11-21 – 2020-12-19 | fda.gov ↗ |
| Approved | US (FDA) | PROHANCE | — | 1992-11-16 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05357833 | Jun 2022 → Sep 2023 | secondary progressive multiple sclerosis | University of Utah | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT05915728 | Jul 2023 → May 2024 | nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT05915702 | Jul 2023 → May 2024 | central nervous system disorder | Bayer | Completed | Met primary |
| Phase 3 | NCT00709852 | Jun 2008 → Apr 2009 | central nervous system disorder | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00522951 | Aug 2007 → Aug 2008 | metastatic malignant neoplasm in the brain | Bayer | Completed | Met primary |
| Phase not applicable2 trials | ||||||
| — | NCT02481882 | Jan 2017 → Oct 2019 | multiple sclerosis | University of Nottingham | Unknown | No outcome recorded |
| — | NCT02359097 | Jan 2015 → Mar 2021 | glioblastoma | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 0 | NCT04861077 Background | Jun 2026 → Aug 2028 expected | triple-negative breast carcinoma | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 1 | NCT04608812 Background | Mar 2021 → Feb 2023 | anaplastic astrocytoma, glioblastoma | OncoSynergy, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04373564 Background | Mar 2021 → Dec 2028 expected | cognitive disorder | Guerbet | Recruiting | No outcome recorded |
| Phase 4 | NCT01613417 Comparator | Aug 2012 → Apr 2014 | brain disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
| Phase 4 | NCT01019486 Background | Nov 2009 → Dec 2011 | coronary artery disorder, type 1 diabetes mellitus | University of Colorado, Denver | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadoteridol | “CMR assessment of stress myocardial perfusion and blood flow after 400 mcg Regadenoson pharmacologic using gadolinium contrast (gadoteridol) 0.05mmole/kg at stress and rest.” NCT01019486 ↗11“Prohance (Gadoteridol) is a gadolinium-based fluid administered intravenously to the participant.” NCT02481882 ↗ “FDA approved gadolinium-contrast agent called Prohance (gadoteridol)” NCT04861077 ↗ “Gadoteridol (ProHance)” NCT00522951 ↗ |
| Known as | NSC-760055 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200593 ↗ |
| Known as | Prohance | “Gadobutrol (Gadavist) and gadoteridol (ProHance) have similar macrocyclic molecular structures” PMID 25300984 ↗ Oct 20144“FDA approved gadolinium-contrast agent called Prohance (gadoteridol)” NCT04861077 ↗ “gadoteridol (ProHance)” NCT00709852 ↗ “Gadoteridol (ProHance)” NCT00522951 ↗ |
| Known as | Prohance (Gadoteridol) | “Prohance (Gadoteridol)” NCT01019486 ↗ |
| Known as | Prohance multipack | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200593 ↗ |
| Known as | SQ 32,692 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1200593 ↗ |
| Modality | Diagnostic / imaging agent | “CMR assessment of stress myocardial perfusion and blood flow after 400 mcg Regadenoson pharmacologic using gadolinium contrast (gadoteridol)” NCT01019486 ↗ |
| Route | Intravenous | “Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw” NCT00522951 ↗ |