Last reviewed 2026-05-30 · How we verify

CETOTIAMINE

Phase 2 active Small molecule ✓ Verified May 2026

CETOTIAMINE is a cetotiamine drug. It is currently in Phase 2 development.

Cetotiamine works by interacting with a specific molecular target, but its exact mechanism is not well understood.

Cetotiamine is a small molecule drug in the cetotiamine class, but its target and mechanism of action are unknown. It is not clear if it is FDA-approved or commercially available. There is limited information available on its pharmacokinetic properties, such as half-life and bioavailability. Cetotiamine's approved indications are also unknown. Further research is needed to understand its clinical use and safety profile.

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	CETOTIAMINE
Drug class	cetotiamine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking them is a specific molecule. Cetotiamine is thought to be that key, but we don't know which lock it fits or how it works once inside. This lack of understanding makes it difficult to predict how it will affect the body.

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:

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

Frequently asked questions about CETOTIAMINE

What is CETOTIAMINE?

CETOTIAMINE is a cetotiamine drug.

How does CETOTIAMINE work?

Cetotiamine works by interacting with a specific molecular target, but its exact mechanism is not well understood.

What drug class is CETOTIAMINE in?

CETOTIAMINE belongs to the cetotiamine class. See all cetotiamine drugs at /class/cetotiamine.

What development phase is CETOTIAMINE in?

CETOTIAMINE is in Phase 2.

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

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