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Mitiglinide | CAS No: 145375-43-5 | GMP-certified suppliers
A medication that manages type 2 diabetes by enhancing insulin secretion to effectively control blood glucose levels and improve postprandial glycemic regulation.
Therapeutic categories
Primary indications
- For the treatment of type 2 diabetes
Product Snapshot
- Mitiglinide is an oral small molecule formulated as a tablet
- It is intended for the treatment of type 2 diabetes
- Currently, Mitiglinide holds investigational status and is not approved in key regulatory markets
Clinical Overview
Pharmacodynamically, mitiglinide acts by stimulating insulin secretion from pancreatic beta-cells. Its primary mechanism of action involves the inhibition of ATP-sensitive potassium (KATP) channels, specifically targeting the Kir6.2/SUR1 complex. Binding to these channels promotes closure, which leads to membrane depolarization. This depolarization triggers the opening of voltage-gated calcium channels, increasing intracellular calcium concentrations. The elevated calcium levels facilitate the exocytosis of insulin-containing granules, thereby enhancing postprandial insulin release.
Mitiglinide is metabolized primarily by the hepatic UGT enzymes UGT1A3 and UGT2B7, which catalyze its glucuronidation. Details on its absorption, distribution, and excretion profiles indicate oral bioavailability with a rapid onset of action, suitable for managing postprandial hyperglycemia. The drug is approved for clinical use in Japan; however, it remains investigational in other regions and has not received approval from the U.S. Food and Drug Administration (FDA).
Safety considerations for mitiglinide include the potential risk of hypoglycemia, consistent with its insulinotropic mechanism. Caution is warranted in patients with compromised hepatic or renal function due to altered metabolism and excretion. Comprehensive safety data remains limited outside its approved markets.
Notable branded formulations are marketed in Japan, where mitiglinide is incorporated into diabetes management regimens aimed at early-phase insulin secretion enhancement.
For pharmaceutical application and sourcing, ensuring the active pharmaceutical ingredient meets rigorous quality standards is critical. This includes confirmation of chemical identity, purity, and compliance with regulatory guidelines such as those outlined by ICH and pharmacopeial standards. Given mitiglinide's metabolic pathway, attention to impurity profiles, especially glucuronidation-related metabolites, is warranted in quality control processes.
Identification & chemistry
| Generic name | Mitiglinide |
|---|---|
| Molecule type | Small molecule |
| CAS | 145375-43-5 |
| UNII | D86I0XLB13 |
| DrugBank ID | DB01252 |
Pharmacology
| Summary | Mitiglinide is a meglitinide-class agent used to manage type 2 diabetes by enhancing insulin secretion from pancreatic beta-cells. It acts primarily by blocking ATP-sensitive potassium (KATP) channels, leading to cellular depolarization and subsequent calcium influx that triggers insulin release. Its pharmacodynamic activity involves modulation of the Kir6.2/SUR1 channel complex and interactions with targets including ATP-binding cassette sub-family C member 8 and PPAR gamma. |
|---|---|
| Mechanism of action | Mitiglinide is thought to stimulate insulin secretion by binding to and blocking ATP-sensitive K(+) (K(ATP)) channels (Kir6.2/SUR1 complex, KATP channels) in pancreatic beta-cells. Closure of potassium channels causes depolarization which stimulates calcium influx through voltage-gated calcium channels. High intracellular calcium subsequently triggers the exocytosis of insulin granules. |
| Pharmacodynamics | Mitiglinide belongs to the meglitinide class of blood glucose-lowering drugs. It is approved for use in Japan but has not yet gained FDA approval. |
Targets
| Target | Organism | Actions |
|---|---|---|
| ATP-binding cassette sub-family C member 8 | Humans | inhibitor |
| Peroxisome proliferator-activated receptor gamma | Humans | agonist |
Formulation & handling
- Mitiglinide is formulated for oral administration as a small molecule in solid tablet form.
- Low water solubility indicates the need for formulation strategies to enhance bioavailability.
- Moderate lipophilicity (LogP ~2.9) suggests potential for good membrane permeability but careful excipient selection is required.
Regulatory status
Mitiglinide is a type of Glycemic Agents
Glycemic agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the treatment of diabetes mellitus. These agents play a crucial role in managing blood glucose levels and improving glycemic control in individuals with diabetes.
One of the key classes of glycemic agents is oral hypoglycemic agents, which are taken by mouth and help lower blood sugar levels. This class includes various subclasses such as sulfonylureas, biguanides, meglitinides, and alpha-glucosidase inhibitors. Sulfonylureas stimulate the release of insulin from the pancreas, while biguanides decrease the production of glucose in the liver and improve insulin sensitivity. Meglitinides work by stimulating insulin secretion, and alpha-glucosidase inhibitors slow down the absorption of carbohydrates from the intestine.
Another important class of glycemic agents is injectable insulin. Insulin is a hormone that regulates glucose metabolism in the body. It is administered via subcutaneous injections and comes in different forms, including short-acting, intermediate-acting, and long-acting insulin. These different formulations allow for precise control of blood glucose levels throughout the day.
Glycemic agents are prescribed based on various factors such as the type of diabetes, severity of the condition, and individual patient characteristics. They are typically used in combination with dietary modifications and lifestyle changes to achieve optimal glycemic control.
Overall, glycemic agents are vital components in the management of diabetes, helping individuals maintain stable blood sugar levels and reducing the risk of complications associated with uncontrolled diabetes.
Mitiglinide API manufacturers & distributors
Compare qualified Mitiglinide API suppliers worldwide. We currently have 1 companies offering Mitiglinide API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Dongbang FTL | Producer | South Korea | South Korea | CoA, JDMF | 13 products |
When sending a request, specify which Mitiglinide API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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