Last reviewed 2026-05-19 · How we verify

LY2140023 Test-High

Denovo Biopharma LLC · Phase 1 active Small molecule ✓ Verified May 2026

LY2140023 Test-High is a Small molecule drug developed by Denovo Biopharma LLC. It is currently in Phase 1 development. Also known as: LY2140023 Monohydrate (Test - High).

LY2140023 is a small molecule that acts as a metabotropic glutamate receptor 2 agonist. This study, NCT01591330, investigated the particle size of three different tablet formulations of LY2140023 in healthy volunteers.

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 name	LY2140023 Test-High
Also known as	LY2140023 Monohydrate (Test - High)
Sponsor	Denovo Biopharma LLC
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study of LY2140023 in Healthy Males and Females (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial 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:

LY2140023 Test-High CI brief — competitive landscape report
LY2140023 Test-High updates RSS · CI watch RSS
Denovo Biopharma LLC portfolio CI

Frequently asked questions about LY2140023 Test-High

What is LY2140023 Test-High?

LY2140023 Test-High is a Small molecule drug developed by Denovo Biopharma LLC.

Who makes LY2140023 Test-High?

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

Is LY2140023 Test-High also known as anything else?

LY2140023 Test-High is also known as LY2140023 Monohydrate (Test - High).

What development phase is LY2140023 Test-High in?

LY2140023 Test-High is in Phase 1.

Manufacturer: Denovo Biopharma LLC — full pipeline
Also known as: LY2140023 Monohydrate (Test - High)

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