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Perfluorobutane (PERFLUBUTANE)

Phase 3 active Small molecule Quality 24/100

Perfluorobutane (generic name: PERFLUBUTANE) is a perflubutane drug. It is currently in Phase 3 development.

Perflubutane works by dissolving in the bloodstream and accumulating in the lungs, allowing for imaging and diagnosis of lung conditions.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 namePERFLUBUTANE
Drug classperflubutane
ModalitySmall molecule
Therapeutic areaRespiratory
PhasePhase 3

Mechanism of action

Imagine a special gas that can be breathed in and then seen on a scan. This gas, perflubutane, is used to help doctors see inside the lungs and diagnose problems. It's like a temporary, invisible dye that helps doctors get a clearer picture of what's going on inside the body.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Perfluorobutane

What is Perfluorobutane?

Perfluorobutane (PERFLUBUTANE) is a perflubutane drug.

How does Perfluorobutane work?

Perflubutane works by dissolving in the bloodstream and accumulating in the lungs, allowing for imaging and diagnosis of lung conditions.

What is the generic name of Perfluorobutane?

PERFLUBUTANE is the generic (nonproprietary) name of Perfluorobutane.

What drug class is Perfluorobutane in?

Perfluorobutane belongs to the perflubutane class. See all perflubutane drugs at /class/perflubutane.

What development phase is Perfluorobutane in?

Perfluorobutane is in Phase 3.

Related

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