Last reviewed 2026-05-23 · How we verify

Trinase

Fayoum University · Phase 1 active Small molecule ✓ Verified May 2026

Trinase is a Small molecule drug developed by Fayoum University. It is currently in Phase 1 development.

Trinase is being studied as a potential treatment for Symptomatic Irreversible Pulpitis, Postoperative Pain After Endodontic Treatment, Endodontic Disease, and Dental Pain. A randomized controlled trial (NCT07239505) is evaluating the effectiveness of Trinase in reducing post-operative pain in patients with Symptomatic Irreversible Pulpitis compared to a placebo.

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	Trinase
Sponsor	Fayoum University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Randomized Controlled Trial Evaluating Whether Pre-operative Trinase Reduces Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis Compared to Placebo, Using VAS Scores and Analgesic Intake Over 48 Hours. (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:

Trinase CI brief — competitive landscape report
Trinase updates RSS · CI watch RSS
Fayoum University portfolio CI

Frequently asked questions about Trinase

What is Trinase?

Trinase is a Small molecule drug developed by Fayoum University.

Who makes Trinase?

Trinase is developed by Fayoum University (see full Fayoum University pipeline at /company/fayoum-university).

What development phase is Trinase in?

Trinase is in Phase 1.

Manufacturer: Fayoum University — full pipeline
Therapeutic area: All drugs in Other

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