Last reviewed 2026-04-20 · How we verify

Pirfenoxone (PIRENOXINE)

Phase 2 active Small molecule

Pirfenoxone (generic name: PIRENOXINE) is a pirenoxine drug. It is currently in Phase 2 development.

Pirfenoxone is believed to modulate cellular processes, although its exact mechanism of action is unknown.

Pirfenoxone, also known as Pirenoxine, is a small molecule drug in the pirenoxine class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating cellular processes. Pirfenoxone is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. As a result, key safety considerations and potential side effects are currently unknown.

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	PIRENOXINE
Drug class	pirenoxine
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key that unlocks a door in a cell. Pirfenoxone is thought to work by interacting with specific molecules inside the cell, which can affect how the cell grows, divides, and responds to its environment. However, the exact details of how it does this are still not well understood.

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:

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

Frequently asked questions about Pirfenoxone

What is Pirfenoxone?

Pirfenoxone (PIRENOXINE) is a pirenoxine drug.

How does Pirfenoxone work?

Pirfenoxone is believed to modulate cellular processes, although its exact mechanism of action is unknown.

What is the generic name of Pirfenoxone?

PIRENOXINE is the generic (nonproprietary) name of Pirfenoxone.

What drug class is Pirfenoxone in?

Pirfenoxone belongs to the pirenoxine class. See all pirenoxine drugs at /class/pirenoxine.

What development phase is Pirfenoxone in?

Pirfenoxone is in Phase 2.

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

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