Last reviewed 2026-05-26 · How we verify

Pentona (MAZATICOL)

Phase 2 active Small molecule ✓ Verified May 2026

Pentona (generic name: MAZATICOL) is a mazaticol drug. It is currently in Phase 2 development for Extrapyramidal sign.

Pentona works by modulating the activity of certain neurotransmitters in the brain.

Pentona is a small molecule medication. It is also known by the synonyms KAO 264, KAO-264, MAZATICOL, MAZATICOL HYDROCHLORIDE.

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	MAZATICOL
Drug class	mazaticol
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a complex network of messengers, called neurotransmitters, that help control your movements. In people with Extrapyramidal signs, these messengers can get out of balance, leading to abnormal movements. Pentona helps restore balance to these messengers, reducing the symptoms of the condition.

Approved indications

Extrapyramidal sign

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:

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

Frequently asked questions about Pentona

What is Pentona?

Pentona (MAZATICOL) is a mazaticol drug, indicated for Extrapyramidal sign.

How does Pentona work?

Pentona works by modulating the activity of certain neurotransmitters in the brain.

What is Pentona used for?

Pentona is indicated for Extrapyramidal sign.

What is the generic name of Pentona?

MAZATICOL is the generic (nonproprietary) name of Pentona.

What drug class is Pentona in?

Pentona belongs to the mazaticol class. See all mazaticol drugs at /class/mazaticol.

What development phase is Pentona in?

Pentona is in Phase 2.

Drug class: All mazaticol drugs
Therapeutic area: All drugs in Neuroscience
Indication: Drugs for Extrapyramidal sign

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