Last reviewed 2026-04-20 · How we verify

Amethone (AMOLANONE)

Phase 2 active Small molecule

Amethone (generic name: AMOLANONE) is a amolanone drug. It is currently in Phase 2 development.

Amethone works by binding to specific biological molecules to produce a therapeutic effect.

Amethone, also known as Amolanone, is a small molecule drug of unknown target and class. Its commercial status and approved indications are currently unknown. As a small molecule, it is likely to work by interacting with specific biological molecules to produce a therapeutic effect. Further information on its pharmacokinetics, safety, and efficacy is needed to fully understand its profile. As a result, it is difficult to provide a comprehensive summary of this compound at this time.

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	AMOLANONE
Drug class	amolanone
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and Amethone is a key that fits into those locks. When it binds to the right lock, it can help to turn off or turn on certain cellular processes that are involved in disease. This can help to restore balance and promote healing in 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:

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

Frequently asked questions about Amethone

What is Amethone?

Amethone (AMOLANONE) is a amolanone drug.

How does Amethone work?

Amethone works by binding to specific biological molecules to produce a therapeutic effect.

What is the generic name of Amethone?

AMOLANONE is the generic (nonproprietary) name of Amethone.

What drug class is Amethone in?

Amethone belongs to the amolanone class. See all amolanone drugs at /class/amolanone.

What development phase is Amethone in?

Amethone is in Phase 2.

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

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