Last reviewed 2026-04-20 · How we verify

Cetylon (CETALKONIUM CHLORIDE)

Phase 2 active Small molecule

Cetylon (generic name: CETALKONIUM CHLORIDE) is a drug. It is currently in Phase 2 development.

Cetylon works by interacting with cell membranes to alter their structure and function.

Cetylon, also known as cetalkonium chloride, is a small molecule compound. Its exact mechanism of action and target are unknown, but it is used in various commercial products. Cetylon is not FDA-approved for any specific indication, and its commercial status is unclear. As a result, there is limited information available on its safety profile and pharmacokinetic properties. Further research is needed to fully understand Cetylon's properties and potential applications.

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 name	CETALKONIUM CHLORIDE
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Imagine Cetylon as a key that fits into a lock on the surface of cells. When it binds, it changes the way the cell membrane works, which can affect how the cell behaves and responds to its environment. This can have various effects on the cell, depending on the specific situation.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (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:

Cetylon CI brief — competitive landscape report
Cetylon updates RSS · CI watch RSS

Frequently asked questions about Cetylon

What is Cetylon?

Cetylon (CETALKONIUM CHLORIDE) is a Small molecule drug.

How does Cetylon work?

Cetylon works by interacting with cell membranes to alter their structure and function.

What is the generic name of Cetylon?

CETALKONIUM CHLORIDE is the generic (nonproprietary) name of Cetylon.

What development phase is Cetylon in?

Cetylon is in Phase 2.

Therapeutic area: All drugs in Metabolic

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