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14C-LY2140023

Denovo Biopharma LLC · Phase 1 active Small molecule ✓ Verified May 2026 Quality 30/100

14C-LY2140023 is a Diagnostic/radiolabeled tracer compound Small molecule drug developed by Denovo Biopharma LLC. It is currently in Phase 1 development.

Radiolabeled prodrug that is converted to LY404039, an agonist of metabotropic glutamate 2/3 receptors.

14C-LY2140023 is a small molecule that acts as a metabotropic glutamate receptor 2 agonist. It was studied in a clinical trial (NCT01637142) to determine its absolute bioavailability in healthy participants.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% 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 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 name14C-LY2140023
SponsorDenovo Biopharma LLC
Drug classDiagnostic/radiolabeled tracer compound
ModalitySmall molecule
PhasePhase 1

Mechanism of action

LY2140023 is a prodrug that is metabolized to the active moiety LY404039, which selectively activates metabotropic glutamate 2 and 3 (mGlu2/3) receptors. The 14C radiolabel allows tracking of drug distribution and metabolism in pharmacokinetic studies.

Approved indications

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 14C-LY2140023

What is 14C-LY2140023?

14C-LY2140023 is a Diagnostic/radiolabeled tracer compound drug developed by Denovo Biopharma LLC.

How does 14C-LY2140023 work?

Radiolabeled prodrug that is converted to LY404039, an agonist of metabotropic glutamate 2/3 receptors.

Who makes 14C-LY2140023?

14C-LY2140023 is developed by Denovo Biopharma LLC (see full Denovo Biopharma LLC pipeline at /company/denovo-biopharma-llc).

What drug class is 14C-LY2140023 in?

14C-LY2140023 belongs to the Diagnostic/radiolabeled tracer compound class. See all Diagnostic/radiolabeled tracer compound drugs at /class/diagnostic-radiolabeled-tracer-compound.

What development phase is 14C-LY2140023 in?

14C-LY2140023 is in Phase 1.

Related

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