Last reviewed 2026-04-20 · How we verify

Malazol (ALLOMETHADIONE)

Phase 2 active Small molecule

Malazol (generic name: ALLOMETHADIONE) is a allomethadione drug. It is currently in Phase 2 development.

Malazol is thought to work by interacting with a specific molecular target, although the exact nature of this interaction is not yet understood.

Malazol, also known as allomethadione, is a small molecule drug of the allomethadione class. Its exact target and mechanism of action are unknown, and it has not been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand the properties and potential uses of Malazol. Due to its lack of FDA approval, Malazol is not currently available as a prescription medication.

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	ALLOMETHADIONE
Drug class	allomethadione
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Malazol is a key that fits into one of those locks. When it binds to the lock, it can affect how the cell works, but we don't yet know how it specifically interacts with the lock or what effects it has on the cell.

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:

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

Frequently asked questions about Malazol

What is Malazol?

Malazol (ALLOMETHADIONE) is a allomethadione drug.

How does Malazol work?

Malazol is thought to work by interacting with a specific molecular target, although the exact nature of this interaction is not yet understood.

What is the generic name of Malazol?

ALLOMETHADIONE is the generic (nonproprietary) name of Malazol.

What drug class is Malazol in?

Malazol belongs to the allomethadione class. See all allomethadione drugs at /class/allomethadione.

What development phase is Malazol in?

Malazol is in Phase 2.

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

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