Dotarem

(Gadoterate meglumine)

ApprovedSmall molecule

GGuerbet

Dotarem is one of 88 small molecule programs targeting Coronary Atherosclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Coronary AtherosclerosisCompleted

Pulmonary FibrosisRecruiting

Interstitial Lung DiseaseRecruiting

Breast CancerActive, not recruiting

Coronary AtherosclerosisApproved

Completed

Pulmonary FibrosisPhase 2

Recruiting

Interstitial Lung DiseasePhase 2

Recruiting

Breast CancerPreclinical

Active, not recruiting

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dotarem

GGuerbet

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Spravato

WWim Janssens

Preclinical

2 7

Duragesic-100

CCephalon

Preclinical

2 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 9

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 10

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Steno-Occlusive Disease

NCT07348640

Q4 2028

Post-ApprovalRecruiting

Study completion

NCT04373564

Phase 2Recruiting

Pulmonary Fibrosis

NCT06532071

Phase 2Recruiting

Interstitial Lung Disease

NCT07572383

Clinical

Trials by Indication[1]

Contrast Enhancement in Magnetic Resonance Imaging2 trials

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Completed· Bayer logo

Bayer·Phase 3·NCT05915702·321 enrolled

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Completed· Bayer logo

Bayer·Phase 3·NCT05915728·410 enrolled

Breast1 trial

Dotarem vs Gadobutrol Contrast for Breast MRI

Completed·UUniversity of Massachusetts, Worcester·Phase 4·NCT03730051·300 enrolled

Advanced Stage1 trial

DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

Terminated·GGuerbet·Phase 4·NCT01806740·37 enrolled

MPA1 trial

Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Terminated·GGuerbet·Phase 3·NCT00845702·33 enrolled

Pulmonary Fibrosis1 trial

Advanced Imaging for Pulmonary Fibrosis

Recruiting·PPeter Caravan·Phase 2·NCT06532071·60 enrolled

6 more indications

Coronary Atherosclerosis1 trial

Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

Completed·GGuerbet·Phase 4·NCT01254552·351 enrolled

CAR1 trial

QSM and Regional DCE MRI Permeability Using GOCART Technique

Withdrawn·UUniversity of Southern California··NCT03091803

Breast Cancer1 trial

Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients

Completed·UUniversity of Campinas, Brazil·N/A·NCT03000036·27 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

Interstitial Lung Disease1 trial

Advanced Imaging to Assess the Effect of Immunosuppression on Progressive Lung Fibrosis in Participants With Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Disease

Recruiting·PPeter Caravan·Phase 2·NCT07572383·15 enrolled

Unspecified1 trial

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

Recruiting·GGuerbet·Phase 4·NCT04373564·2,076 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 31, 2017

DOTAREM

NDA NDA204781

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Gadoterate meglumine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gadoterate meglumine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gadoterate meglumine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA204781). U.S. Food & Drug Administration.
[5]
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

Dotarem

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2028

Trials by Indication[1]

Contrast Enhancement in Magnetic Resonance Imaging2 trials

Breast1 trial

Advanced Stage1 trial

MPA1 trial

Pulmonary Fibrosis1 trial

Coronary Atherosclerosis1 trial

CAR1 trial

Breast Cancer1 trial

Steno-occlusive Disease1 trial

Interstitial Lung Disease1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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