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IOBITRIDOL
IOBITRIDOL is a iobitridol drug. It is currently in Phase 3 development.
IOBITRIDOL works by providing contrast in radiographic imaging to help visualize internal structures and abnormalities.
IOBITRIDOL is a small molecule modality used in medical imaging, specifically in laparoscopic procedures such as cholecystectomy and cholelithiasis treatment. It is administered in conjunction with Indocyanine Green (ICG) and Xenetix-CT perfusion imaging for image-guided laparoscopic surgery.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | IOBITRIDOL |
|---|---|
| Drug class | iobitridol |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Imagine you're trying to see a small object in a dark room. IOBITRIDOL helps doctors see inside the body by providing a contrast that makes internal structures stand out, allowing them to diagnose and treat conditions more effectively.
Approved indications
Common side effects
- Drug reaction with eosinophilia and systemic symptoms
- Acute kidney injury
- Rash maculo-papular
- Toxic skin eruption
- Acute generalised exanthematous pustulosis
Key clinical trials
- Computed Tomography Vs. Endoscopy Study
- Low-contrast Dose Liver CT Using Lean Body Weight Low Monoenergetic Images and Deep Learning-based Reconstruction (NA)
- Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy (NA)
- Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis (PHASE4)
- Hepatic Xenetix-CT Perfusion (PHASE4)
- Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (PHASE4)
- Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship (EARLY_PHASE1)
- A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications (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:
- IOBITRIDOL CI brief — competitive landscape report
- IOBITRIDOL updates RSS · CI watch RSS
Frequently asked questions about IOBITRIDOL
What is IOBITRIDOL?
How does IOBITRIDOL work?
What drug class is IOBITRIDOL in?
What development phase is IOBITRIDOL in?
What are the side effects of IOBITRIDOL?
Related
- Drug class: All iobitridol drugs
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing