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Ametop
Ametop is a Small molecule drug developed by University of British Columbia. It is currently in Phase 3 development. Also known as: Ametop Gel, amethocaine.
Ametop is a small molecule that acts as a sodium channel alpha subunit blocker, classified as a blocker. It is used for dental anesthesia and has been studied for its effectiveness in treating various conditions, including upper aerodigestive tract lesions and oropharyngeal cancer.
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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 | Ametop |
|---|---|
| Also known as | Ametop Gel, amethocaine |
| Sponsor | University of British Columbia |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Virtual Reality for Port-a-Cath Access (NA)
- Clinical Evaluation of no Needle Dental Anesthesia Compared to Syringe Anesthesia Delivery (EARLY_PHASE1)
- Optimal Treatment Protocol for Selective Laser Trabeculoplasty (NA)
- Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial (NA)
- Evaluate the TetraLens, a Tetracaine Releasing Therapeutic Bandage Contact Lens in Patients Undergoing PRK Procedure (EARLY_PHASE1)
- Safety and Efficacy of Stem Cell Small Extracellular Vesicles in Patients With Retinitis Pigmentosa (PHASE1, PHASE2)
- Uddevalla Skövde Transscleral Micropulse Study
- Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General (PHASE2)
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:
- Ametop CI brief — competitive landscape report
- Ametop updates RSS · CI watch RSS
- University of British Columbia portfolio CI
Frequently asked questions about Ametop
What is Ametop?
Who makes Ametop?
Is Ametop also known as anything else?
What development phase is Ametop in?
Related
- Manufacturer: University of British Columbia — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Ametop Gel, amethocaine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing