Last reviewed 2026-05-26 · How we verify

Tricalcium silicate sealar

Armed Forces Institute of Dentistry, Pakistan · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Tricalcium silicate sealar is a Small molecule drug developed by Armed Forces Institute of Dentistry, Pakistan. It is currently in Phase 1 development. Also known as: CeraSeal sealer, bioceramic sealer, calcium silicate sealer.

Tricalcium silicate sealer has been studied in clinical trials for its potential to reduce pain after root canal treatment. The exact mechanism of action of tricalcium silicate sealer is currently unknown.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Tricalcium silicate sealar
Also known as	CeraSeal sealer, bioceramic sealer, calcium silicate sealer
Sponsor	Armed Forces Institute of Dentistry, Pakistan
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers (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:

Tricalcium silicate sealar CI brief — competitive landscape report
Tricalcium silicate sealar updates RSS · CI watch RSS
Armed Forces Institute of Dentistry, Pakistan portfolio CI

Frequently asked questions about Tricalcium silicate sealar

What is Tricalcium silicate sealar?

Tricalcium silicate sealar is a Small molecule drug developed by Armed Forces Institute of Dentistry, Pakistan.

Who makes Tricalcium silicate sealar?

Tricalcium silicate sealar is developed by Armed Forces Institute of Dentistry, Pakistan (see full Armed Forces Institute of Dentistry, Pakistan pipeline at /company/armed-forces-institute-of-dentistry-pakistan).

Is Tricalcium silicate sealar also known as anything else?

Tricalcium silicate sealar is also known as CeraSeal sealer, bioceramic sealer, calcium silicate sealer.

What development phase is Tricalcium silicate sealar in?

Tricalcium silicate sealar is in Phase 1.

Manufacturer: Armed Forces Institute of Dentistry, Pakistan — full pipeline
Also known as: CeraSeal sealer, bioceramic sealer, calcium silicate sealer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing