Last reviewed 2026-05-18 · How we verify

Imeglimin Reference product

Poxel SA · Phase 1 active Small molecule Quality 40/100

Imeglimin Reference product is a Antidiabetic agent Small molecule drug developed by Poxel SA. It is currently in Phase 1 development.

Imeglimin targets mitochondrial bioenergetics to improve glucose metabolism and insulin sensitivity.

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	Imeglimin Reference product
Sponsor	Poxel SA
Drug class	Antidiabetic agent
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Imeglimin acts on mitochondria to restore cellular energy metabolism. It enhances insulin secretion from pancreatic beta cells, improves insulin sensitivity in peripheral tissues, and reduces hepatic glucose production through modulation of mitochondrial function.

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.

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:

Imeglimin Reference product CI brief — competitive landscape report
Imeglimin Reference product updates RSS · CI watch RSS
Poxel SA portfolio CI

Frequently asked questions about Imeglimin Reference product

What is Imeglimin Reference product?

Imeglimin Reference product is a Antidiabetic agent drug developed by Poxel SA.

How does Imeglimin Reference product work?

Imeglimin targets mitochondrial bioenergetics to improve glucose metabolism and insulin sensitivity.

Who makes Imeglimin Reference product?

Imeglimin Reference product is developed by Poxel SA (see full Poxel SA pipeline at /company/poxel-sa).

What drug class is Imeglimin Reference product in?

Imeglimin Reference product belongs to the Antidiabetic agent class. See all Antidiabetic agent drugs at /class/antidiabetic-agent.

What development phase is Imeglimin Reference product in?

Imeglimin Reference product is in Phase 1.

Drug class: All Antidiabetic agent drugs
Manufacturer: Poxel SA — full pipeline

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