Drugs / Gadopiclenol
Gadopiclenol
Regulatory milestones approvals, filings & regulatory actions · 4 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 ↗ |
| Filed | US (FDA) | — | — | 2022-03-29 | “has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)” guerbet.com ↗ |
Trials 19
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 36 trials · 3 met primary | ||||||
| Phase 3 | NCT07348640 | Jul 2026 → Dec 2027 expected | arterial disorder | Guerbet | 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 | Met primary |
| Phase 3 | NCT03986138 | Aug 2019 → Dec 2020 | peripheral nerve lesion | Guerbet | Completed | Met primary |
| Phase 3 | NCT03996447 | Jun 2019 → Sep 2020 | — | Guerbet | Completed | Met primary |
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06086704 Background | Sep 2024 → Aug 2028 expected | breast cancer | University of Wisconsin, Madison | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-04-17 | Bracco Diagnostics, Inc | Regulatory Bracco Receives Health Canada Approval for gadopiclenol injection, Advancing Lower-Dose MRI Contrast Imaging bracco.com ↗
Bracco Imaging, a global leader in diagnostic imaging, today announced that on April 10, 2026, Health Canada approved VUEWAY ® injection (gadopiclenol), a macrocyclic gadolinium-based contrast agent (GBCA), for use in contrast-enhanced magnetic resonance imaging (CE-MRI). |
| 2026-01-27 | Guerbet | Regulatory New indication in children from birth for Guerbet’s half-dose GBCA, Elucirem™ (Gadopiclenol) approved by European Commission guerbet.com ↗
Guerbet (FR0000032526 GBT), a global specialist in contrast media and solutions for medical imaging, is delighted to announce the approval by European Commission of a new indication in children from birth for its macrocyclic high-relaxivity gadolinium-based contrast agent, Elucirem™ (gadopiclenol) in European Union (EU). |
| 2026-01-26 | Bracco Diagnostics, Inc | Regulatory The European Commission granted Marketing Authorisation for gadopiclenol for its use in pediatric patients under 2 years bracco.com ↗
Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on January 23, 2026, the European Commission (EC) amended the Marketing Authorisation for VUEWAY ® (gadopiclenol) in the European Union (EU), extending its approved indications to pediatric patients below 2 years of age. |
| 2025-12-19 | Guerbet | Regulatory CHMP grants positive opinion for Elucirem™ (gadopiclenol) pediatric indication extension under two years of age guerbet.com ↗
GUERBET (FR0000032526 GBT) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Elucirem™ (gadopiclenol) for contrast-enhanced‑ MRI in children from birth. |
| 2023-12-11 | Bracco Diagnostics, Inc | Regulatory The EC granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union bracco.com ↗
Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway ® (gadopiclenol) in the European Union. |
| 2023-10-12 | Bracco Diagnostics, Inc | Regulatory Vueway® (Gadopiclenol) Receives Positive CHMP Opinion bracco.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the macrocyclic, high-relaxivity Vueway ® (Gadopiclenol) in adults and pediatric patients older than 2 years of age. |
| 2022-06-13 | Guerbet | Regulatory Guerbet receives EMA acceptance of Elucirem™ as the Brand Name for Gadopiclenol. guerbet.com ↗
Guerbet (FR0000032526 GBT), a global leader in medical imaging, announces today that Elucirem™, the proposed Guerbet brand name for Gadopiclenol, has been accepted by the European Medicines Agency (EMA). |
| 2022-03-29 | Guerbet | Regulatory Gadopiclenol Marketing Authorization dossier submissions accepted for review by EMA and FDA Priority Review granted by US-FDA guerbet.com ↗
In addition, the US-FDA has accepted the request for Priority Review with a goal date for taking action on an application by September 21, 2022. |
| 2021-03-24 | Guerbet | Results Gadopiclenol: positive results for Phase III clinical trials guerbet.com ↗
Gadopiclenol: positive results for Phase III clinical trials |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 20 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 | P03277 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03749252 ↗ |
| 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 ↗ |