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Butafenone (DIPRAFENONE)

Phase 2 active Small molecule

Butafenone (generic name: DIPRAFENONE) is a diprafenone drug. It is currently in Phase 2 development.

Butafenone works by binding to the Beta-1 adrenergic receptor, which is involved in regulating heart rate and blood pressure.

Butafenone, also known as Diprafenone, is a small molecule drug that targets the Beta-1 adrenergic receptor. It is classified as a diprafenone and its mechanism of action is not well-documented. As a result, there is limited information available on its approved indications, commercial status, and key safety considerations. Further research is needed to fully understand the properties and effects of Butafenone. Unfortunately, due to the lack of available information, a comprehensive summary cannot be provided.

Likelihood of approval
13.3% 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).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
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 nameDIPRAFENONE
Drug classdiprafenone
TargetBeta-1 adrenergic receptor, Potassium voltage-gated channel subfamily H member 2, Sodium channel protein type 5 subunit alpha
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Think of it like a key fitting into a lock. Butafenone is the key that fits into the Beta-1 adrenergic receptor, which is like a lock on the heart. When the key fits into the lock, it helps to slow down the heart rate and reduce blood pressure.

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:

Frequently asked questions about Butafenone

What is Butafenone?

Butafenone (DIPRAFENONE) is a diprafenone drug.

How does Butafenone work?

Butafenone works by binding to the Beta-1 adrenergic receptor, which is involved in regulating heart rate and blood pressure.

What is the generic name of Butafenone?

DIPRAFENONE is the generic (nonproprietary) name of Butafenone.

What drug class is Butafenone in?

Butafenone belongs to the diprafenone class. See all diprafenone drugs at /class/diprafenone.

What development phase is Butafenone in?

Butafenone is in Phase 2.

What does Butafenone target?

Butafenone targets Beta-1 adrenergic receptor, Potassium voltage-gated channel subfamily H member 2, Sodium channel protein type 5 subunit alpha and is a diprafenone.

Related

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