Last reviewed 2026-04-19 · How we verify

Phytonail

National Taiwan University Hospital · Phase 1 active Small molecule

Phytonail is a Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 1 development. Also known as: herbal ingredients combined with a carrier system (Phytonail).

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	Phytonail
Also known as	herbal ingredients combined with a carrier system (Phytonail)
Sponsor	National Taiwan University Hospital
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 Study to Evaluate the Efficacy of Herbal Ingredients Combined With a Carrier System (Phytonail) Compared With Amorolfine 5% Nail Lacquer (Loceryl) in the Treatment of Toenail Onychomycosis (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:

Phytonail CI brief — competitive landscape report
Phytonail updates RSS · CI watch RSS
National Taiwan University Hospital portfolio CI

Frequently asked questions about Phytonail

What is Phytonail?

Phytonail is a Small molecule drug developed by National Taiwan University Hospital.

Who makes Phytonail?

Phytonail is developed by National Taiwan University Hospital (see full National Taiwan University Hospital pipeline at /company/national-taiwan-university-hospital).

Is Phytonail also known as anything else?

Phytonail is also known as herbal ingredients combined with a carrier system (Phytonail).

What development phase is Phytonail in?

Phytonail is in Phase 1.

Manufacturer: National Taiwan University Hospital — full pipeline
Therapeutic area: All drugs in Other
Also known as: herbal ingredients combined with a carrier system (Phytonail)

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