Omniscan

(Gadodiamide)

ApprovedSmall molecule

GGE Healthcare

Omniscan is one of 45 small molecule programs targeting Renal insufficiency. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Renal InsufficiencyActive, not recruiting

Renal InsufficiencyApproved

Active, not recruiting

Competition

Competitive Landscape

119 competitors in Renal Insufficiency

#DrugCompanyPhaseTrials

Galvus

Novartis

Phase 3

4 2

Afinitor

Novartis

Phase 3

1 3

Januvia

ZZydus Therapeutics Inc.

Phase 3

2 4

Deltavit

HHyundai Pharmaceutical Co., LTD.

Phase 3

1 5

Calcineurin Inhibitors

Sanofi

Phase 3

1 6

Cysteine Hydrochloride

Novartis

Phase 2

1 7

Omniscan

GGE Healthcare

Approved

1 8

Velcade

SShilpa Grover, MD, MPH

Phase 2

2 9

Decadron

AAspen Global Incorporated

Phase 2

2 10

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Phase 2

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

Timeline

Expected Milestones

Q4 2028

Post-ApprovalRecruiting

Study completion

NCT04373564

Clinical

Trials by Indication[1]

Renal insufficiency1 trial

Safety Evaluation of Linear and Macrocyclic Gadolinium Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging

Unknown status·TThe Central Hospital of Lishui City·Phase 4·NCT04776187·600 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide

Completed·GGE Healthcare·Phase 3·NCT00209443·407 enrolled

Efficacy1 trial

A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

Completed·GGE Healthcare·Phase 3·NCT00209391·395 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]

Jan 8, 1993

OMNISCAN

NDA NDA020123

Sep 5, 2007

OMNISCAN

NDA NDA022066

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Gadodiamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Gadodiamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Gadodiamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022066). U.S. Food & Drug Administration.
[5]
SEC EDGAR — GE Healthcare company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGE Healthcare

Omniscan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Trials by Indication[1]

Renal insufficiency1 trial

Safety and Efficacy1 trial

Efficacy1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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