TheraRadar
Data updated: May 26, 2026

CERETEC (technetium tc-99m exametazime kit)

Radiopharmaceutical Activity
Cardiovascular Approved 1988-12-30

CERETEC is indicated for the treatment of Stroke; Intra-Abdominal Infection; Inflammatory Bowel Disease.

Source: FDA Label • GE HEALTHCARE
2
Indications
--
Phase 3 Trials
1
Priority Reviews
37
Years on Market

Details

Status
Prescription
First Approved
1988-12-30
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

CERETEC Approval History

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Original
New Indication
New Form
Label Update
18 FDA actions from 1988 to 2018
Sep 2018 SUPPL
Label · Labeling
Apr 2016 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2014 SUPPL Priority
Mfg · Manufacturing (CMC)

What CERETEC Treats

3 indications

CERETEC is approved for 3 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Stroke
  • Intra-Abdominal Infection
  • Inflammatory Bowel Disease
Source: FDA Label

CERETEC Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in CERETEC's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CERETEC treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to CERETEC

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Shared indications:
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CERETEC FDA Label Details

Indications & Usage

FDA Label (PDF)

CERETEC is indicated for the treatment of Stroke; Intra-Abdominal Infection; Inflammatory Bowel Disease.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.