Last reviewed 2026-05-14 · How we verify

Cleofil (DIFEMETOREX)

Phase 2 active Small molecule

Cleofil (generic name: DIFEMETOREX) is a diphemethoxidine drug. It is currently in Phase 2 development.

Cleofil works by interacting with cellular processes to produce its effects.

Cleofil, also known as DIFEMETOREX, is a small molecule drug in the diphemethoxidine class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating certain cellular processes. Cleofil's commercial status and approved indications are unclear, and it is not known whether it is patented or available as a generic. Further research is needed to fully understand its effects and potential uses. As a result, key safety considerations and pharmacokinetic properties, such as half-life and bioavailability, are also unknown.

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	DIFEMETOREX
Drug class	diphemethoxidine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your cells are like a city with many different buildings and roads. Cleofil is like a traffic controller that helps regulate the flow of information and materials between the different parts of the city. By doing so, it can influence how the city functions and responds to different situations.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

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

Frequently asked questions about Cleofil

What is Cleofil?

Cleofil (DIFEMETOREX) is a diphemethoxidine drug.

How does Cleofil work?

Cleofil works by interacting with cellular processes to produce its effects.

What is the generic name of Cleofil?

DIFEMETOREX is the generic (nonproprietary) name of Cleofil.

What drug class is Cleofil in?

Cleofil belongs to the diphemethoxidine class. See all diphemethoxidine drugs at /class/diphemethoxidine.

What development phase is Cleofil in?

Cleofil is in Phase 2.

Drug class: All diphemethoxidine drugs
Therapeutic area: All drugs in Other

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