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iodinated contrast dye
iodinated contrast dye is a Small molecule drug developed by American College of Radiology Imaging Network. It is currently in Phase 2 development. Also known as: iodinated radiographic dye.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | iodinated contrast dye |
|---|---|
| Also known as | iodinated radiographic dye |
| Sponsor | American College of Radiology Imaging Network |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Ultra-low Dose Contrast for Endovascular Procedures
- Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer (EARLY_PHASE1)
- The MATCH Investigation: CT Myocardial Perfusion and CT-FFR vs PET MPI (NA)
- Contrast Enhanced Spectral Mammography for the Evaluation of Pathologic Nipple Discharge (NA)
- Comparison of CE-DBT and MRI in Patients With Known Breast Lesions (EARLY_PHASE1)
- Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS (NA)
- Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion (NA)
- Thyroid Function of Pediatric Subjects Following Isovue® Administration (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- iodinated contrast dye CI brief — competitive landscape report
- iodinated contrast dye updates RSS · CI watch RSS
- American College of Radiology Imaging Network portfolio CI
Frequently asked questions about iodinated contrast dye
What is iodinated contrast dye?
Who makes iodinated contrast dye?
Is iodinated contrast dye also known as anything else?
What development phase is iodinated contrast dye in?
Related
- Manufacturer: American College of Radiology Imaging Network — full pipeline
- Also known as: iodinated radiographic dye
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing