Drug

Imeglimin

In clinical development

Emerging researchLate-stage development

Also known as Imeglimina, Iméglimine, Imegliminum.

RxNorm1406596 ChEMBLCHEMBL4297514 ATCA10BX15UNIIUU226QGU97

Research papers

Active clinical trials

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)

Clinical trial2026-04-09Results expected Q3 2026 · ClinicalTrials.gov

Mechanism of action of Imeglimin: A novel therapeutic agent for type 2 diabetes.

Research2020-12-29Diabetes, obesity & metabolism

An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects

Clinical trial2019-07-08Completed · ClinicalTrials.gov

A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects

Clinical trial2018-10-02Completed · ClinicalTrials.gov

An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects

Clinical trial2018-07-27Completed · ClinicalTrials.gov

A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects

Clinical trial2016-12-01Completed · ClinicalTrials.gov

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects

Clinical trial2015-10-01Completed · ClinicalTrials.gov

A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.

Clinical trial2014-07-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Imeglimin

Aliases & brands

ImegliminaIméglimineImegliminum

RxNorm CUI

1406596

ChEMBL ID

CHEMBL4297514

ATC codes

A10BX15

UNII

UU226QGU97

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2019

Active studies

Recruiting

Late-stage (III+)

Completed

PHASE DISTRIBUTIONn = 8

Phase 15Phase 21Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)

Active, not recruitingPH IVNational Center for Global Health and Medicine, Japann=5672027

Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy

Not yet recruitingPH IVMansoura Universityn=1762026

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects

CompletedPH IPoxel SAn=142019

A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects

CompletedPH IPoxel SAn=162018

An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects

CompletedPH IPoxel SAn=162018

A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects

CompletedPH IPoxel SAn=552016

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects

CompletedPH IPoxel SAn=482015

CompletedPH IIPoxel SAn=3152014

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Mechanism of action of Imeglimin: A novel therapeutic agent for type 2 diabetes.

Diabetes, obesity & metabolism · 2021 · 136 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Insulin

Studied across the same disease area as Imeglimin in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials