Last reviewed 2026-05-30 · How we verify

Varnishes, Fluorid

Cairo University · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Varnishes, Fluorid is a Small molecule drug developed by Cairo University. It is currently in Phase 1 development.

Varnishes, Fluorid are small molecule compounds that contain fluoride ions, which are used as a treatment for conditions such as dentine hypersensitivity. They are studied as a non-invasive treatment option for sensitivity in permanent teeth with molar incisor hypomineralization, often compared to other treatments like potassium nitrate gel and nano hydroxy apatite varnish.

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	Varnishes, Fluorid
Sponsor	Cairo University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Three Different Topically Applied Materials as Non-invasive Treatment of Sensitivity in Permanent Teeth With Molar Incisor Hypomineralization (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:

Varnishes, Fluorid CI brief — competitive landscape report
Varnishes, Fluorid updates RSS · CI watch RSS
Cairo University portfolio CI

Frequently asked questions about Varnishes, Fluorid

What is Varnishes, Fluorid?

Varnishes, Fluorid is a Small molecule drug developed by Cairo University.

Who makes Varnishes, Fluorid?

Varnishes, Fluorid is developed by Cairo University (see full Cairo University pipeline at /company/cairo-university).

What development phase is Varnishes, Fluorid in?

Varnishes, Fluorid is in Phase 1.

Manufacturer: Cairo University — full pipeline

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