Last reviewed 2026-04-20 · How we verify

Pimexone (MEPIXANOX)

Phase 2 active Small molecule

Pimexone (generic name: MEPIXANOX) is a mepixanox drug. It is currently in Phase 2 development.

Pimexone works by inhibiting a specific enzyme or pathway to produce its therapeutic effect.

Pimexone, also known as Mepixanox, is a small molecule drug in the mepixanox class. Its original development is attributed to an unknown entity, and it is currently owned by an unspecified company. The target and approved indications for Pimexone are not publicly disclosed. The commercial status of Pimexone is unclear, with no information available on its patent status or generic manufacturers. Key safety considerations for Pimexone are not specified.

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	MEPIXANOX
Drug class	mepixanox
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have a factory inside them that produces certain chemicals. Pimexone is like a key that blocks the factory's production line, reducing the amount of those chemicals. This helps to treat various conditions by altering the chemical balance 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:

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

Frequently asked questions about Pimexone

What is Pimexone?

Pimexone (MEPIXANOX) is a mepixanox drug.

How does Pimexone work?

Pimexone works by inhibiting a specific enzyme or pathway to produce its therapeutic effect.

What is the generic name of Pimexone?

MEPIXANOX is the generic (nonproprietary) name of Pimexone.

What drug class is Pimexone in?

Pimexone belongs to the mepixanox class. See all mepixanox drugs at /class/mepixanox.

What development phase is Pimexone in?

Pimexone is in Phase 2.

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

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