Elucirem

(Gadopiclenol)

ApprovedSmall molecule

GGuerbet

Elucirem is one of 35 small molecule programs targeting Prostate Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Prostate CancerSuspended

Magnetic Resonance ImagingRecruiting

Prostate CancerApproved

Suspended

Magnetic Resonance ImagingApproved

Recruiting

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Elucirem

GGuerbet

Approved

1 2

Docetaxel /m²

AstraZeneca

Phase 3

2 3

PSMA-1007

AABX advanced biochemical compounds GmbH

Phase 3

3 4

Fuzuloparib

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

1 5

INR101

YYunhe Pharmaceutical (Tianjin) Co., Ltd

Phase 3

3 6

Trexall

Jazz Pharmaceuticals

Preclinical

—7

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 8

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

1 9

Duragesic

CCephalon

Preclinical

1 10

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Steno-Occlusive Disease

NCT07348640

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

Safety and Efficacy1 trial

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

Completed·GGuerbet·Phase 2·NCT05590884·36 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

CNS Tumors1 trial

MRI Gadopiclenol Enhanced Imaging of CNS Tumors

Withdrawn·MMedical University of South Carolina··NCT06127810

Tics1 trial

Pharmacokinetics and Safety of Gadopiclenol in Japanese Healthy Volunteers

Completed·GGuerbet·Phase 1·NCT04906005·27 enrolled

5 more indications

Congenital Heart Disease1 trial

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

Completed·UUniversity of California, San Diego·Phase 3·NCT06406517·161 enrolled

Adrenal1 trial

Randomized, Single-Blind, Monocentric, Non-Inferiority Trial of Gadopiclenol (Vueway®) Contrast Agent Performance vs. Gadobutrol (Gadovist®) in the Workup of Incidental Renal and Adrenal Findings

Terminated·IInsel Gruppe AG, University Hospital Bern·Approved·NCT07040865·17 enrolled

Steno-occlusive Disease1 trial

A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

Recruiting·GGuerbet·Phase 3·NCT07348640·315 enrolled

Prostate Cancer1 trial

Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.

Suspended·CColumbia University·Approved·NCT06226129·150 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

Sep 21, 2022

ELUCIREM

NDA NDA216986

Jan 26, 2024

ELUCIREM

NDA NDA216986

Jul 23, 2024

ELUCIREM

NDA NDA216986

Aug 14, 2024

ELUCIREM

NDA NDA216986

Mar 5, 2025

ELUCIREM

NDA NDA216986

Feb 20, 2026

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: Approved[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

Q4 2027

Trials by Indication[1]

Magnetic Resonance Imaging (MRI)2 trials

Safety and Efficacy1 trial

Magnetic Resonance Imaging1 trial

CNS Tumors1 trial

Tics1 trial

Congenital Heart Disease1 trial

Adrenal1 trial

Steno-occlusive Disease1 trial

Prostate Cancer1 trial

Lesion in Body Region1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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