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TheraCal PT
TheraCal PT is a Small molecule drug developed by Cairo University. It is currently in Phase 1 development. Also known as: TheraCal PT®.
TheraCal PT is a premixed bioceramic putty used as an apical plug in nonvital immature anterior teeth. It has been studied in clinical trials for various dental conditions, including periapical periodontitis, root canal infection, reversible pulpitis, pulp disease, and carious dentin.
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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 | TheraCal PT |
|---|---|
| Also known as | TheraCal PT® |
| Sponsor | Cairo University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of the Success of TheraCal PT in Pulpotomy Treatment of Primary Teeth Using Low-Level Laser Therapy (NA)
- Comparison Of Clinical And Radiological Success Of Pulpotomy Treatments Performed With Proroot MTA, NeoPUTTY MTA, TheraCal PT In Primary Teeth (NA)
- Clinical and Radiographic Outcomes of Partial Pulpotomy Procedure in Primary Molars Utilizing Different Capping Materials and Different Restorative Methods (NA)
- Outcomes of Partial Pulpotomy Treatment in Cariously Exposed Teeth (PHASE4)
- Clinical Success of Indirect Pulp Capping: 1-Year Follow-Up (NA)
- Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth (NA)
- Evaluation of Primary Tooth Pulpotomy With Resin Modified Calcium Silicate (NA)
- Postoperative Pain After Full Pulpotomy With TheraCal PT, Biodentin, and MTA (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:
- TheraCal PT CI brief — competitive landscape report
- TheraCal PT updates RSS · CI watch RSS
- Cairo University portfolio CI
Frequently asked questions about TheraCal PT
What is TheraCal PT?
Who makes TheraCal PT?
Is TheraCal PT also known as anything else?
What development phase is TheraCal PT in?
Related
- Manufacturer: Cairo University — full pipeline
- Also known as: TheraCal PT®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing