Dotarem

(Gadoterate meglumine)

ApprovedSmall molecule

GGuerbet

Dotarem is one of 110 small molecule programs targeting Coronary Atherosclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

109

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Coronary AtherosclerosisActive, not recruiting

Pulmonary FibrosisActive, not recruiting

Breast CancerActive, not recruiting

Vascular DiseaseActive, not recruiting

Coronary AtherosclerosisApproved

Active, not recruiting

Pulmonary FibrosisPhase 2

Active, not recruiting

Breast CancerPreclinical

Active, not recruiting

Vascular DiseasePhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dotarem

GGuerbet

Approved

1 2

DATROWAY

Daiichi Sankyo

Preclinical

4 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Zinecard

CChildren's Oncology Group

Preclinical

2 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Aquasol E

NNational Eye Institute (NEI)

Systemic Therapy

1 10

Zoladex

Luye Pharma Group Ltd.

Preclinical

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

Timeline

Expected Milestones

Q4 2027

Phase 3Not yet recruiting

Vascular Disease

NCT07348640

Q4 2028

Phase 2Recruiting

Pulmonary Fibrosis

NCT06532071

Post-ApprovalRecruiting

Study completion

NCT04373564

Clinical

Trials by Indication[1]

Contrast Agent2 trials

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Completed· Bayer logo

Bayer·Phase 3·NCT05915728·404 enrolled

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems

Completed· Bayer logo

Bayer·Phase 3·NCT05915702·303 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

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

Pulmonary Fibrosis1 trial

Advanced Imaging for Pulmonary Fibrosis

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

5 more indications

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

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

MPA1 trial

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

Terminated·GGuerbet·Phase 3·NCT00845702·33 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 — 11 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 Agent2 trials

Breast1 trial

Advanced Stage1 trial

Coronary Atherosclerosis1 trial

Pulmonary Fibrosis1 trial

CAR1 trial

Breast Cancer1 trial

Vascular Disease1 trial

MPA1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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