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Fluorescein SDU
Fluorescein SDU is a Small molecule drug developed by Medical University of Vienna. It is currently in Phase 3 development for Diagnostic or surgical visualization (specific indication not publicly detailed).
Fluorescein SDU is a fluorescent dye conjugate designed to enhance visualization of tissue during diagnostic or surgical procedures.
Fluorescein SDU is a diagnostic eye drop used to study tear film characteristics and ocular surface disease. It is typically administered as a single instillation in combination with oxybuprocaine, a local anesthetic.
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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 | Fluorescein SDU |
|---|---|
| Sponsor | Medical University of Vienna |
| Modality | Small molecule |
| Therapeutic area | Diagnostics/Imaging |
| Phase | Phase 3 |
Mechanism of action
Fluorescein SDU likely combines fluorescein, a well-established fluorescent tracer, with a targeting or delivery moiety (SDU) to improve optical imaging and tissue localization. The fluorescent properties enable real-time visualization under appropriate wavelengths, potentially improving diagnostic accuracy or surgical guidance in clinical applications.
Approved indications
- Diagnostic or surgical visualization (specific indication not publicly detailed)
Common side effects
Key clinical trials
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:
- Fluorescein SDU CI brief — competitive landscape report
- Fluorescein SDU updates RSS · CI watch RSS
- Medical University of Vienna portfolio CI
Frequently asked questions about Fluorescein SDU
What is Fluorescein SDU?
How does Fluorescein SDU work?
What is Fluorescein SDU used for?
Who makes Fluorescein SDU?
What development phase is Fluorescein SDU in?
Related
- Manufacturer: Medical University of Vienna — full pipeline
- Therapeutic area: All drugs in Diagnostics/Imaging
- Indication: Drugs for Diagnostic or surgical visualization (specific indication not publicly detailed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing