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Dibenon (BERMOPROFEN)

Phase 2 active Small molecule ✓ Verified Jun 2026

Dibenon (generic name: BERMOPROFEN) is a bermoprofen drug. It is currently in Phase 2 development.

Dibenon works by inhibiting enzymes involved in inflammation.

Dibenon is a small molecule with the synonyms AD-1590, AJ-1590, BERMOPROFEN, BERMOPROFENE, BERMOPROFENO, and DIBENON.

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 nameBERMOPROFEN
Drug classbermoprofen
ModalitySmall molecule
Therapeutic areaPain
PhasePhase 2

Mechanism of action

Think of inflammation like a fire in your body. Dibenon is like a fire extinguisher that helps put out the flames by blocking the chemicals that make the fire worse. This can help reduce pain and swelling.

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 Dibenon

What is Dibenon?

Dibenon (BERMOPROFEN) is a bermoprofen drug.

How does Dibenon work?

Dibenon works by inhibiting enzymes involved in inflammation.

What is the generic name of Dibenon?

BERMOPROFEN is the generic (nonproprietary) name of Dibenon.

What drug class is Dibenon in?

Dibenon belongs to the bermoprofen class. See all bermoprofen drugs at /class/bermoprofen.

What development phase is Dibenon in?

Dibenon is in Phase 2.

Related

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