Elucirem

(Gadopiclenol)

Phase 3Small molecule

GGuerbet

Elucirem is one of 43 small molecule programs targeting Lesion in Body Region. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Lesion in Body RegionCompleted

Vascular DiseaseActive, not recruiting

Lesion in Body RegionPhase 3

Completed

Vascular DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

66 competitors in Vascular Disease

#DrugCompanyPhaseTrials

Crestor

AstraZeneca

Approved

2 2

Repatha

Amgen

Approved

1 3

Precose

Bayer

Approved

1 4

Letairis

Gilead

Approved

—5

Colcrys

Alnylam Pharmaceuticals

Approved

—6

Zesly

MMezzion Pharma Co. Ltd

Approved

1 7

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Approved

1 8

Andriol

AAuxilium

Approved

1 9

Donepezil Hydrochloride

Eisai

Approved

2 10

Cleviprex

Chiesi Farmaceutici S.p.A.

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Post-ApprovalRecruiting

Contrast Agent

NCT07040865

Q4 2027

Phase 3Not yet recruiting

Vascular Disease

NCT07348640

Q1 2028

Post-ApprovalRecruiting

Prostate

NCT06226129

Clinical

Trials by Indication[1]

Magnetic Resonance Imaging (MRI)2 trials

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Completed·GGuerbet·Phase 3·NCT03996447·260 enrolled

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Completed·GGuerbet·Phase 3·NCT03986138·324 enrolled

Effectiveness1 trial

Comparative Effectiveness of Gadopiclenol for Evaluation of Adult Congenital Heart Anatomy and Hemodynamics

Not yet recruiting·UUniversity of California, San Diego·Phase 3·NCT06406517·160 enrolled

Vascular Disease1 trial

Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Not yet recruiting·GGuerbet·Phase 3·NCT07348640·315 enrolled

Tics1 trial

Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers

Completed·GGuerbet·Phase 1·NCT04906005·27 enrolled

Magnetic Resonance Imaging1 trial

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)

Recruiting·UUConn Health·Phase 4·NCT06846853·10 enrolled

5 more indications

Prostate1 trial

Gadopiclenol in Contrast Enhanced MRI of the Prostate

Recruiting·—·Phase 4·NCT06226129·150 enrolled

CNS Tumors1 trial

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

Withdrawn·MMedical University of South Carolina··NCT06127810

Safety and Efficacy1 trial

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

Completed·GGuerbet·Phase 2·NCT05590884·36 enrolled

Contrast Agent1 trial

Randomized Comparison of Contrast Agents Gadopiclenol and Gadobutrol in the Workup of Incidental Renal and Adrenal Findings

Recruiting·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT07040865·104 enrolled

Lesion in Body Region1 trial

Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Completed·GGuerbet·Phase 3·NCT06010173·240 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 21, 2022

ELUCIREM

NDA NDA216986

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Gadopiclenol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gadopiclenol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gadopiclenol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216986). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Elucirem. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Guerbet company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGuerbet

Patent Landscape[5]

Patent Cliff

Sep 19, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8114863Sep 19, 2028

10973934Aug 6, 2039

12064487Jan 17, 2040

11590246Jan 17, 2040

Elucirem

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Magnetic Resonance Imaging (MRI)2 trials

Effectiveness1 trial

Vascular Disease1 trial

Tics1 trial

Magnetic Resonance Imaging1 trial

Prostate1 trial

CNS Tumors1 trial

Safety and Efficacy1 trial

Contrast Agent1 trial

Lesion in Body Region1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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