Last reviewed 2026-04-20 · How we verify

Octofene (CLOFOCTOL)

Phase 2 active Small molecule

Octofene (generic name: CLOFOCTOL) is a clofoctol drug. It is currently in Phase 2 development.

Octofene works by interacting with a specific target to produce its therapeutic effect.

Octofene, also known as CLOFOCTOL, is a small molecule drug in the clofoctol class. It is currently owned by an unknown entity, and its target and exact mechanism of action are not specified. Octofene is not FDA-approved, and its commercial status, including patent and generic availability, is unknown. As a result, there is limited information available on its approved indications, half-life, bioavailability, and key safety considerations. Further research is needed to fully understand the properties and uses of Octofene.

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	CLOFOCTOL
Drug class	clofoctol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and Octofene has a key that fits into those locks. When it binds to the lock, it triggers a response that helps to treat a particular condition. This is a simplified explanation of how Octofene works at a molecular level.

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:

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

Frequently asked questions about Octofene

What is Octofene?

Octofene (CLOFOCTOL) is a clofoctol drug.

How does Octofene work?

Octofene works by interacting with a specific target to produce its therapeutic effect.

What is the generic name of Octofene?

CLOFOCTOL is the generic (nonproprietary) name of Octofene.

What drug class is Octofene in?

Octofene belongs to the clofoctol class. See all clofoctol drugs at /class/clofoctol.

What development phase is Octofene in?

Octofene is in Phase 2.

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

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