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Monolithic zirconia
Monolithic zirconia is a Small molecule drug developed by Universidad Complutense de Madrid. It is currently in Phase 1 development. Also known as: Zenostar T; Wieland Dental.
Monolithic zirconia is a type of ceramic material used in dental restorations, specifically in full coverage crowns. It has been studied in clinical trials for its effects on oral health quality of life and tooth loss in patients with endodontically treated posterior teeth.
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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 | Monolithic zirconia |
|---|---|
| Also known as | Zenostar T; Wieland Dental |
| Sponsor | Universidad Complutense de Madrid |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effect of Fabrication Monolithic Zirconia Endocrown on Marginal Integrity (NA)
- Monolithic Zirconia Full-Arch Rehabilitation Using Digital Technology (NA)
- Passive Fit of Implant-Supported Complete-Arch Prostheses Using Digital Workflows (NA)
- Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible
- Patient Satisfaction and Clinical Performance of Ultra-translucent Multi-layer Monolithic Zirconia and Lithium Disilicate Ceramic Laminate Veneers. Randomized Control Clinical Trial (NA)
- Evaluation of Occlusal Adjustment Material Removal on Monolithic Zirconia Blocks: An In Vitro Study
- Performance of CAD/CAM Milled and 3D-printed Full-arch Implant-supported Provisionals Restorations (NA)
- Zirconium Dioxide Fixed Dental Prosthesis. (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:
- Monolithic zirconia CI brief — competitive landscape report
- Monolithic zirconia updates RSS · CI watch RSS
- Universidad Complutense de Madrid portfolio CI
Frequently asked questions about Monolithic zirconia
What is Monolithic zirconia?
Who makes Monolithic zirconia?
Is Monolithic zirconia also known as anything else?
What development phase is Monolithic zirconia in?
Related
- Manufacturer: Universidad Complutense de Madrid — full pipeline
- Also known as: Zenostar T; Wieland Dental
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing