Back to discover
Drug

Repaglinide

Established medicine
ClassSulfonylurea receptor 1, Kir6.2 blockerResearchActive indication expansion
Also known as PrandiMet, Prandin, Repaglinide-Metformin, Repaglinida+1 more

PrandiMet, Prandin, Repaglinide-Metformin, Repaglinida, Repaglinidum.

RxNorm73044ChEMBLCHEMBL1272ATCA10BX02UNII668Z8C33LU
4
Active clinical trials
2
Protein targets
6
Regulatory events
Latest activity
beta

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

Supplemental approval: REPAGLINIDE (ANDA207209)

Regulatory2026-08-07FDA

A Phase 1b, Open Label, 2-Part Study to Evaluate the Effect of Pelabresib (DAK539/CPI-0610) on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Drospirenone/Ethinyl Estradiol Oral Contraceptive in Patients With Advanced Malignancies

Clinical trial2026-07-09Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Clinical trial2026-05-27Results expected Q4 2027 · ClinicalTrials.gov

The Effect of Multiple Doses of BI 1569912 on the Single-dose Pharmacokinetics of Repaglinide, Midazolam and Bupropion Following Oral Administration in Healthy Male and Female Subjects (an Open-label, 2-period Fixed-sequence Trial)

Clinical trial2026-05-22Results posted · ClinicalTrials.gov

A Phase 1, Open-label, 2-part, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.

Clinical trial2026-03-12Results expected Q1 2027 · ClinicalTrials.gov

A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

Clinical trial2025-12-23Completed · ClinicalTrials.gov

The Effect of Imlunestrant on CYP2C8, CYP2C19, CYP2D6, P-gp, and BCRP Activity and the Effect of P-gp Inhibition on Imlunestrant Pharmacokinetics in Healthy Women of Non-childbearing Potential

Clinical trial2025-12-12Results posted · ClinicalTrials.gov

An Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of LOXO-292 on the Single Dose Pharmacokinetics of Repaglinide in Healthy Adult Subjects

Clinical trial2025-12-11Results posted · ClinicalTrials.gov

The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-period, Fixed-sequence Trial)

Clinical trial2025-12-02Results posted · ClinicalTrials.gov

Approval: REPAGLINIDE (ANDA207209)

Regulatory2023-03-22FDA

Approval: Repaglinide Accord (EMA)

Regulatory2011-12-22EMA

Approval: Repaglinide Krka (EMA)

Regulatory2009-11-03EMA

Profile

Identifiers & mechanism

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

Canonical name
Repaglinide
Aliases & brands
PrandiMetPrandinRepaglinide-MetforminRepaglinidaRepaglinidum
RxNorm CUI
73044
ChEMBL ID
CHEMBL1272
ATC codes
A10BX02
UNII
668Z8C33LU
Primary mechanism
Sulfonylurea receptor 1, Kir6.2 blocker
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

ATP-sensitive inward rectifier potassium channel 11
KCNJ11 · Q14654
BLOCKERSulfonylurea receptor 1, Kir6.2 blocker
ATP-binding cassette sub-family C member 8
ABCC8 · Q09428
BLOCKERSulfonylurea receptor 1, Kir6.2 blocker

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-06-28
Latest approval
2026-08-07
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 2 events
2026-08-07Supplemental approval
Supplemental approval: REPAGLINIDE (ANDA207209)
Evidence ↗
2023-03-22Approval
Approval: REPAGLINIDE (ANDA207209)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2011-12-22Approval
Approval: Repaglinide Accord (EMA)
Indication: Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by… Show full indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Evidence ↗
2009-11-03Approval
Approval: Repaglinide Krka (EMA)
Indication: Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by… Show full indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Evidence ↗
2009-10-13Approval
Approval: Enyglid (EMA)
Indication: Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by… Show full indication

Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

56 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
56
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
4
Recruiting
24
Late-stage (III+)
49
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 56
Phase 131Phase 1 / 21Phase 33Phase 419Phase N / A2

Late-stage studies

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

A 26-Week, Multi-Center, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-Term Intensive Insulin Therapy: Basal Insulin Based Treatment (With Prandial OADs Combination) Versus Twice-daily Premixed Insulin

CompletedPH IVSanofin=3842020

A Randomised Controlled Trial for People With Established Type 2 Diabetes During Ramadan: Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen: The 'Can Do Ramadan' Study

CompletedPH IVUniversity of Leicestern=252018

Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study

CompletedPH IVUniversity of Palermon=922018

A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus

CompletedPH IVKey trialMerck Sharp & Dohme LLCn=5,5702015

Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China

CompletedPH IVRenJi Hospitaln=1072014

Recent completions

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

A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

CompletedPH IInstitut de Recherches Internationales Servier (I.R.I.S.)n=282025

An Open-label, Fixed-sequence, Three-part Study to Assess the Effect of AZD5004 on the Pharmacokinetics of Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and to Assess the Effect of Erythromycin on AZD5004 in Healthy Participants

CompletedPH IAstraZenecan=492025

A Phase 1, Single-center, Open-label, Fixed-sequence, Crossover Study to Evaluate the Effect of LY4100511 (DC-853) on the Single-dose Pharmacokinetics of Midazolam, Repaglinide, Digoxin, and Rosuvastatin in Healthy Participants

CompletedPH IDICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Companyn=492024

The Effect of Multiple Doses of Zongertinib on the Single-dose Pharmacokinetics of Midazolam, Omeprazole and Repaglinide in Healthy Male Subjects (an Open-label, 2-period, Fixed-sequence Trial)

CompletedPH IBoehringer Ingelheimn=162024

The Effect of Multiple Doses of BI 1569912 on the Single-dose Pharmacokinetics of Repaglinide, Midazolam and Bupropion Following Oral Administration in Healthy Male and Female Subjects (an Open-label, 2-period Fixed-sequence Trial)

CompletedPH IBoehringer Ingelheimn=182024

A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)

CompletedPH IDeciphera Pharmaceuticals, LLCn=132024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.