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Menthol, NF 5.00 %

Express Specialty Pharmacy · Phase 2 active Small molecule

Menthol, NF 5.00 % is a Small molecule drug developed by Express Specialty Pharmacy. It is currently in Phase 2 development. Also known as: Menthol.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameMenthol, NF 5.00 %
Also known asMenthol
SponsorExpress Specialty Pharmacy
ModalitySmall molecule
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about Menthol, NF 5.00 %

What is Menthol, NF 5.00 %?

Menthol, NF 5.00 % is a Small molecule drug developed by Express Specialty Pharmacy.

Who makes Menthol, NF 5.00 %?

Menthol, NF 5.00 % is developed by Express Specialty Pharmacy (see full Express Specialty Pharmacy pipeline at /company/express-specialty-pharmacy).

Is Menthol, NF 5.00 % also known as anything else?

Menthol, NF 5.00 % is also known as Menthol.

What development phase is Menthol, NF 5.00 % in?

Menthol, NF 5.00 % is in Phase 2.

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