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Decapinol (DELMOPINOL)

Phase 2 active Small molecule

Decapinol (generic name: DELMOPINOL) is a delmopinol drug. It is currently in Phase 2 development for Dental plaque.

Decapinol works by preventing the adhesion of bacteria to tooth surfaces.

Decapinol, also known as delmopinol, is a small molecule drug in the delmopinol class. It is used to treat dental plaque, a condition where bacteria accumulate on teeth. The commercial status of Decapinol is unclear, but it is likely patented. Key safety considerations include unknown half-life and bioavailability. Decapinol is owned by an unknown entity.

Likelihood of approval
17.3% 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).
  • Anti-infectives pathway favourability +2.0pp
    Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
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 nameDELMOPINOL
Drug classdelmopinol
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 2

Mechanism of action

This means that Decapinol creates a barrier on the teeth that prevents bacteria from sticking to them, making it harder for plaque to form. This helps to prevent the development of gum disease and other oral health issues.

Approved indications

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

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Decapinol

What is Decapinol?

Decapinol (DELMOPINOL) is a delmopinol drug, indicated for Dental plaque.

How does Decapinol work?

Decapinol works by preventing the adhesion of bacteria to tooth surfaces.

What is Decapinol used for?

Decapinol is indicated for Dental plaque.

What is the generic name of Decapinol?

DELMOPINOL is the generic (nonproprietary) name of Decapinol.

What drug class is Decapinol in?

Decapinol belongs to the delmopinol class. See all delmopinol drugs at /class/delmopinol.

What development phase is Decapinol in?

Decapinol is in Phase 2.

Related

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