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Benoral (BENORILATE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Benoral (generic name: BENORILATE) is a benorilate drug. It is currently in Phase 2 development.

Benoral is thought to work by interacting with a specific biological target, although its exact mechanism of action is currently unknown.

Benoral is a small molecule with an unknown mechanism of action. It is also known by several synonyms, including Benorilate, Benorylate, and Triadol.

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 nameBENORILATE
Drug classbenorilate
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 2

Mechanism of action

Imagine your body's cells are like locks, and benoral is a key that fits into one of those locks. When benoral binds to its target, it can either block or enhance the activity of that target, leading to changes in the way the body functions. However, without more information, it's difficult to say exactly how benoral works or what effects it might have on the body.

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 Benoral

What is Benoral?

Benoral (BENORILATE) is a benorilate drug.

How does Benoral work?

Benoral is thought to work by interacting with a specific biological target, although its exact mechanism of action is currently unknown.

What is the generic name of Benoral?

BENORILATE is the generic (nonproprietary) name of Benoral.

What drug class is Benoral in?

Benoral belongs to the benorilate class. See all benorilate drugs at /class/benorilate.

What development phase is Benoral in?

Benoral is in Phase 2.

Related

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