Drugs / Gadopiclenol
Gadopiclenol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ELUCIREM | — | 2026-02-20 | fda.gov ↗ |
| Approved | EU (EMA) | Elucirem | — | 2023-12-07 | europa.eu ↗ |
| Approved | US (FDA) | ELUCIREM | — | 2022-09-21 | fda.gov ↗ |
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04906005 | May → Jul 2021 | — | Guerbet | Completed | No outcome recorded |
| Phase 1 | NCT03657784 | Oct 2017 → Feb 2019 | impaired renal function disease | Guerbet | Completed | No outcome recorded |
| Phase 1 | NCT03657264 | Aug 2017 → Jun 2018 | — | Guerbet | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03603106 | Nov 2013 → Apr 2015 | — | Guerbet | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT05590884 | Sep 2022 → Sep 2024 | central nervous system disorder | Guerbet | Completed | No outcome recorded |
| Phase 2 | NCT03749252 | Nov 2018 → Dec 2019 | central nervous system disorder | Guerbet | Completed | No outcome recorded |
| Phase 2 | NCT02973516 | Dec 2016 → Apr 2019 | hepatocellular carcinoma | Guerbet | Completed | No outcome recorded |
| Phase 2 | NCT02633501 | Jun 2016 → Jan 2018 | — | Guerbet | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07348640 | Feb 2026 → Dec 2027 expected | arterial disorder | Guerbet | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06406517 | May 2024 → Jun 2025 | congenital heart disease | University of California, San Diego | Unknown | No outcome recorded |
| Phase 3 | NCT06057168 | Sep 2023 → Nov 2024 | brain cancer, primary brain neoplasm | Guerbet | Completed | No outcome recorded |
| Phase 3 | NCT06010173 | Jul 2023 → May 2025 | peripheral nerve lesion | Guerbet | Completed | No outcome recorded |
| Phase 3 | NCT03986138 | Aug 2019 → Dec 2020 | peripheral nerve lesion | Guerbet | Completed | No outcome recorded |
| Phase 3 | NCT03996447 | Jun 2019 → Sep 2020 | — | Guerbet | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07346131 | Jan → Oct 2026 expected | — | Hôpital Fribourgeois | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07040865 | Aug 2025 → Jun 2027 expected | — | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT05954559 | Aug 2025 → Dec 2026 expected | heart disorder | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 4 | NCT06846853 | Mar 2025 → Jun 2026 overdue | — | UConn Health | Recruiting | No outcome recorded |
| Phase 4 | NCT06226129 | Feb 2024 → Feb 2027 | prostate cancer | Columbia University | Suspended | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07415018 | Jun 2026 → Jul 2027 expected | neoplastic meningitis | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06086704 Background | Sep 2024 → Jan 2027 expected | breast cancer | University of Wisconsin, Madison | Recruiting | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gadopiclenol | “Injection protocol 1: gadopiclenol 2 mL/s” NCT07346131 ↗ |
| Known as | Elucirem | “Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for...” NCT05954559 ↗3“Gadopiclenol (brand name Elucirem), initially invented by Guerbet, is an FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity and high kinetic stability.” NCT06846853 ↗ “Gadopiclenol (Elucirem)” NCT06226129 ↗ |
| Known as | gadobenate dimuglumine | “gadobenate dimuglumine” NCT06086704 ↗ |
| Known as | P03277 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03749252 ↗ |
| Known as | VUEWAY | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07415018 ↗ |
| Modality | Diagnostic / imaging agent | “new gadolinium-based contrast agent (GBCA) P03277” NCT02633501 ↗ |
| Route | Intravenous | “Single intravenous (IV) bolus injection at a rate of 2 mL/second” NCT02633501 ↗ |