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Carbamide Peroxide 10%
Carbamide Peroxide 10% is a Small molecule drug developed by Federal University of Minas Gerais. It is currently in Phase 1 development. Also known as: Group 3 - CP 10%, 10% carbamide peroxide bleaching gel.
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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 | Carbamide Peroxide 10% |
|---|---|
| Also known as | Group 3 - CP 10%, 10% carbamide peroxide bleaching gel |
| Sponsor | Federal University of Minas Gerais |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Tooth Sensitivity (Score of <3)
Key clinical trials
- Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards (NA)
- Clinical Evaluation of Enamel Microhardness Using Tooth Whitening Agents (NA)
- PATIENT SATISFACTION AND MASKING OF WHITE SPOT LESIONS AFTER HOME WHITENING WITH 10% CARBAMIDE PEROXIDE (NA)
- At-home Bleaching Using Clear Retainers (NA)
- Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching (NA)
- The Association of CPP-ACPF Associated With LASER in the Treatment of Tooth Sensitivity After at Home Bleaching (NA)
- Bleaching Procedures Performed During Treatment With Brackets and Clear Aligners (NA)
- Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene (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:
- Carbamide Peroxide 10% CI brief — competitive landscape report
- Carbamide Peroxide 10% updates RSS · CI watch RSS
- Federal University of Minas Gerais portfolio CI
Frequently asked questions about Carbamide Peroxide 10%
What is Carbamide Peroxide 10%?
Who makes Carbamide Peroxide 10%?
Is Carbamide Peroxide 10% also known as anything else?
What development phase is Carbamide Peroxide 10% in?
What are the side effects of Carbamide Peroxide 10%?
Related
- Manufacturer: Federal University of Minas Gerais — full pipeline
- Also known as: Group 3 - CP 10%, 10% carbamide peroxide bleaching gel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing