Last reviewed 2026-05-31 · How we verify

Cleanal (FUDOSTEINE)

Phase 2 active Small molecule ✓ Verified May 2026

Cleanal (generic name: FUDOSTEINE) is a fudosteine drug. It is currently in Phase 2 development.

Cleanal works by inhibiting the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine.

Cleanal (FUDOSTEINE) is a small molecule drug in the fudosteine class, but specific details about its target, indications, and commercial status are unknown. As a fudosteine, it is likely involved in the treatment of respiratory conditions, but further information is needed to confirm its use. The mechanism of action and pharmacokinetic properties of Cleanal are also unclear. Further research is necessary to determine its safety profile and potential side effects. As a result, Cleanal is not yet a well-established treatment option.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	FUDOSTEINE
Drug class	fudosteine
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of acetylcholine like a messenger in your body that helps your muscles relax and your airways open. When acetylcholinesterase breaks it down, the message is lost. Cleanal blocks this enzyme, allowing acetylcholine to stay active longer and help your body relax and open up your airways.

Approved indications

No approved indications tracked.

Common side effects

Pneumonia

Competitive intelligence

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

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

Frequently asked questions about Cleanal

What is Cleanal?

Cleanal (FUDOSTEINE) is a fudosteine drug.

How does Cleanal work?

Cleanal works by inhibiting the enzyme acetylcholinesterase, which breaks down the neurotransmitter acetylcholine.

What is the generic name of Cleanal?

FUDOSTEINE is the generic (nonproprietary) name of Cleanal.

What drug class is Cleanal in?

Cleanal belongs to the fudosteine class. See all fudosteine drugs at /class/fudosteine.

What development phase is Cleanal in?

Cleanal is in Phase 2.

What are the side effects of Cleanal?

Common side effects of Cleanal include Pneumonia.

Drug class: All fudosteine drugs
Therapeutic area: All drugs in Neuroscience

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