NDAORALTABLETPriority Review
Approved
Dec 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
PRANDIN (repaglinide) by Molecular Devices is pancreas. First approved in 1997.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRANDIN (repaglinide) is an oral meglitinide that stimulates insulin secretion from pancreatic beta cells by closing ATP-dependent potassium channels, leading to calcium influx and glucose-dependent insulin release. It is indicated for type 2 diabetes management as monotherapy or combination therapy. The mechanism is highly tissue-selective with minimal effects on cardiac and skeletal muscle.
LOE Approaching
As LOE approaches, commercial teams face contraction pressure and focus will shift toward managed decline and generic optimization strategies.
Mechanism of Action
pancreas. This action is dependent upon functioning beta (ß) cells in the pancreatic islets. Insulin release is glucose-dependent and diminishes at low glucose concentrations. Repaglinide closes ATP-dependent potassium channels in the ß-cell membrane by binding at characterizable sites. This…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
Started Jun 2026
24 enrolled
Advanced Malignancies
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.
Started Jan 2026
Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
Started Oct 2025
28 enrolled
Healthy Adult Participants
Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants
Started May 2025
24 enrolled
Pharmacokinetic ProfilesY-3 for InjectionDrug-drug Interaction+4 more
A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants
Started May 2025
49 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.