gadopiclenol

Trade name: Elucirem

Small moleculeapprovedImaging agent

Approved

Sep 21, 2022

Clinical trial activity

11 trials · 11 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
6
Phase 3
5
Phase 4
4

Earliest trial started Jun 3, 2019 (NCT03996447)

Timeline

2010s

  1. Jan 1, 2019

    Guerbet — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Guerbet — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2022

    Guerbet — Earliest Phase 2 Sponsor(trial)

  3. Sep 21, 2022

    Guerbet — Earliest FDA Approval

  4. Sep 21, 2022

    Guerbet — Marketing Organization

  5. Sep 21, 2022

    Guerbet — NDA Secondary Org

  6. Sep 21, 2022

    Guerbet — NDA Organization

Indications

Mechanism of action

  • gadolinium other

  • Unspecified targetOTHER

    Diagnostic agent

Approval history

  • approvedPriority reviewSep 21, 2022

Chemistry & pharmacology

Mol. weight
970.1 g/mol
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07040865Phase 4Aug 18, 2025University of Bern
NCT06846853Phase 4Mar 1, 2025University of Connecticut
NCT06406517Phase 3May 31, 2024Bracco, University of California, San Diego
NCT06226129Phase 4Feb 14, 2024Guerbet, University of Massachusetts
NCT05954559Phase 4Jan 31, 2024Albert Einstein Israelite Hospital, Canon Medical Systems, USA, Johns Hopkins University
NCT06057168Phase 3Sep 7, 2023Guerbet
NCT06010173Phase 3Jul 21, 2023Bracco, Guerbet, Nagoya University
NCT05590884Phase 2Sep 21, 2022Guerbet, Medical University of South Carolina
NCT04906005Phase 1May 10, 2021Guerbet
NCT03986138Phase 3Jun 30, 2019Guerbet
NCT03996447Phase 3Jun 3, 2019Guerbet
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GuerbetFor profit7642019
BraccoFor profit2012023
Albert Einstein Israelite HospitalAcademic/Hospital1012024
Canon Medical Systems, USAFor profit1012024
Johns Hopkins UniversityAcademic/Hospital1112024
Medical University of South CarolinaAcademic/Hospital1012022
Nagoya UniversityAcademic/Hospital1012023
University of BernAcademic/Hospital1112025
University of California, San DiegoAcademic/Hospital1112024
University of ConnecticutAcademic/Hospital1112025
University of MassachusettsAcademic/Hospital1112024
11 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
GuerbetFor profitMKTGSep 21, 2022
GuerbetFor profitNDA2Sep 21, 2022
GuerbetFor profitNDASep 21, 2022