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Urografin
Urografin is a Small molecule drug developed by Hvidovre University Hospital. It is currently in Phase 1 development.
Urografin is a small molecule contrast agent used during X-ray imaging, including visualizing veins, the urinary system, spleen, and joints, as well as computer tomography. It can be administered through various routes, including oral, intravenous, intravesical, and rectal.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Urografin |
|---|---|
| Sponsor | Hvidovre University Hospital |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction (NA)
- Use of a Water Soluble Contrast-Based Protocol to Assist in the Management of Pediatric Adhesive Small Bowel Obstruction
- Optimizing Treatment of Adhesive Small Bowel Obstruction (PHASE3)
- Fluorescence Cholangiography During Cholecystectomy - a RCT (NA)
- Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure (PHASE3)
- Gastrografin for Treating Small Bowel Obstruction in Children (PHASE2, PHASE3)
- The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients. (PHASE4)
- Serum Thyroid Function After Iodinated Contrast Administration
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:
- Urografin CI brief — competitive landscape report
- Urografin updates RSS · CI watch RSS
- Hvidovre University Hospital portfolio CI
Frequently asked questions about Urografin
What is Urografin?
Who makes Urografin?
What development phase is Urografin in?
Related
- Manufacturer: Hvidovre University Hospital — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing