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Icon Infiltrant
Icon Infiltrant is a Small molecule drug developed by King Abdullah University Hospital. It is currently in Phase 1 development. Also known as: ICON (DMG, NJ, US).
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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 | Icon Infiltrant |
|---|---|
| Also known as | ICON (DMG, NJ, US) |
| Sponsor | King Abdullah University Hospital |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities (NA)
- Resin Infiltration vs Ionomer-Based Fluoride Varnish for the Prevention of Post-Eruptive Breakdown in Molars With Mild MIH (NA)
- Etch-bleach-seal Technique in Managing Opacities Related MIH Using Icon® (NA)
- Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions (EARLY_PHASE1)
- Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children (PHASE3)
- Color Masking Potential of Bioactive and ICON Materials (NA)
- Clinical Trial Proximal Caries Infiltration and Detection (NA)
- 12 Month Follow up in Vivo Icon Study on Fluorotic Teeth (NA)
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:
- Icon Infiltrant CI brief — competitive landscape report
- Icon Infiltrant updates RSS · CI watch RSS
- King Abdullah University Hospital portfolio CI
Frequently asked questions about Icon Infiltrant
What is Icon Infiltrant?
Who makes Icon Infiltrant?
Is Icon Infiltrant also known as anything else?
What development phase is Icon Infiltrant in?
Related
- Manufacturer: King Abdullah University Hospital — full pipeline
- Also known as: ICON (DMG, NJ, US)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing