Last reviewed · How we verify

Neodyne (ETHYL DIBUNATE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Neodyne (generic name: ETHYL DIBUNATE) is a drug. It is currently in Phase 2 development.

Neodyne works by binding to specific proteins or receptors in the body, altering their function and leading to a therapeutic effect.

Neodyne Biosciences, Inc. is conducting a study on a novel silicone dressing, known as the Neodyne Device, to minimize scar formation. The study is focused on conditions such as hypertrophic scars, cicatrix, and breast reconstruction.

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 nameETHYL DIBUNATE
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like a orchestra, and the proteins or receptors are like the musicians. Neodyne is like a conductor that helps the musicians play in harmony, leading to a desired outcome. However, if the conductor is too loud or too soft, it can cause problems, and that's where the safety considerations come in.

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 Neodyne

What is Neodyne?

Neodyne (ETHYL DIBUNATE) is a Small molecule drug.

How does Neodyne work?

Neodyne works by binding to specific proteins or receptors in the body, altering their function and leading to a therapeutic effect.

What is the generic name of Neodyne?

ETHYL DIBUNATE is the generic (nonproprietary) name of Neodyne.

What development phase is Neodyne in?

Neodyne is in Phase 2.

Related

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