Last reviewed 2026-04-20 · How we verify

Methafenilene (METHAPHENILENE)

Phase 2 active Small molecule

Methafenilene (generic name: METHAPHENILENE) is a drug. It is currently in Phase 2 development.

Methaphenilene is a small molecule compound that works by interacting with a specific biological target, although its exact mechanism of action is currently unknown.

Methaphenilene is a small molecule compound with unknown target and drug class. Its development and current ownership are not specified. There is no information available on its FDA approval status, approved indications, half-life, bioavailability, generic manufacturers, or off-patent status. As a result, its commercial status and key safety considerations are unknown. Further research is required to understand its potential therapeutic applications and risks.

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	METHAPHENILENE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and methaphenilene is a key that fits into one of those locks. When it binds to the lock, it can either turn the lock open or closed, depending on the type of lock and the key's shape. This interaction can affect how cells behave and communicate with each other, potentially leading to changes in the body's function or response to disease.

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:

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

Frequently asked questions about Methafenilene

What is Methafenilene?

Methafenilene (METHAPHENILENE) is a Small molecule drug.

How does Methafenilene work?

Methaphenilene is a small molecule compound that works by interacting with a specific biological target, although its exact mechanism of action is currently unknown.

What is the generic name of Methafenilene?

METHAPHENILENE is the generic (nonproprietary) name of Methafenilene.

What development phase is Methafenilene in?

Methafenilene is in Phase 2.

Therapeutic area: All drugs in Other

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