MedPath

Glyburide

Generic Name
Glyburide
Brand Names
Diabeta, Glucovance, Glynase, Amglidia
Drug Type
Small Molecule
Chemical Formula
C23H28ClN3O5S
CAS Number
10238-21-8
Unique Ingredient Identifier
SX6K58TVWC
Background

Glyburide is a second generation sulfonylurea used to treat patients with diabetes mellitus type II. It is typically given to patients who cannot be managed with the standard first line therapy, metformin. Glyburide stimulates insulin secretion through the closure of ATP-sensitive potassium channels on beta cells, raising intracellular potassium and calcium ion concentrations.

Glyburide was granted FDA approval on 1 May 1984. A formulation with metformin was granted FDA approval on on 31 July 2000.

Indication

Glyburide is indicated alone or as part of combination product with metformin, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions
Gestational Diabetes Mellitus (GDM), Glycemic Control, Type 2 Diabetes Mellitus

Sigachi Industries Secures European Certification for Metformin Hydrochloride API

• Sigachi Industries' subsidiary Trimax Biosciences has received Certificate of Suitability (CEP) from European Directorate for Quality of Medicines, enabling export of metformin hydrochloride to European markets. • Metformin hydrochloride, a first-line therapy for type 2 diabetes, is projected to reach a market value of USD 386.91 million by 2030, growing at a CAGR of 4.7%. • The certification aligns with Sigachi's strategic goal to expand into highly regulated pharmaceutical markets and reinforces the company's ability to meet stringent EU standards for safety and efficacy.

ESTEVE Acquires Global Rights to Increlex for Rare Growth Disorder Treatment

• ESTEVE has signed a licensing agreement with Eton Pharmaceuticals for global rights to Increlex®, a biologic treatment for severe primary insulin-like growth factor-1 deficiency (SPIGFD), excluding the US market. • The acquisition aligns with ESTEVE's strategic focus on specialized treatments for high unmet medical needs, marking the company's first biologic product in its portfolio. • Increlex® is approved for treating growth failure in children and adolescents aged 2-18 years with SPIGFD, a rare condition where patients have low levels of IGF-1 hormone essential for normal growth.

Eton Pharmaceuticals Poised for Growth with Expanding Rare Disease Portfolio and Pending FDA Approvals

• Eton Pharmaceuticals is anticipating FDA approval for ET-400 in early June, with commercial launch planned immediately following approval and significant revenue impact expected in Q3 and Q4 2025. • The company has successfully relaunched Increlex for growth disorders, reaching over 90 patients, and Galzin for Wilson disease, with improved patient access and a $0 co-pay program. • Eton is pursuing label expansion for Increlex based on European patient registry data, with an FDA meeting expected in July and submission planned for Q3 2025.

Eton Pharmaceuticals' ET-600 Meets Bioequivalence Endpoints for Central Diabetes Insipidus Treatment

• Eton Pharmaceuticals' ET-600, a patented desmopressin oral solution, successfully demonstrated pharmacokinetic equivalence to the FDA-approved reference product in a pivotal study with 75 subjects. • The company plans to submit a New Drug Application to the FDA in April 2025, positioning ET-600 to potentially become the only FDA-approved oral liquid formulation of desmopressin. • If approved, ET-600 would address a significant unmet need for pediatric patients with central diabetes insipidus who require precise, titratable dosing, with potential market launch in Q1 2026.

Indian Pharma Companies to Launch Generic Empagliflozin at 90% Lower Cost

• Several Indian pharmaceutical companies are preparing to launch generic versions of Empagliflozin following Boehringer Ingelheim's patent expiry on March 11, potentially transforming diabetes treatment accessibility. • Mankind Pharma plans to offer the diabetes medication at approximately Rs 6 per tablet, a 90% reduction from the innovator's price of Rs 60, with most generic versions expected to cost between Rs 9-14 per tablet. • The affordable generics will significantly reduce therapy costs for India's 10.1 crore diabetic patients, most of whom pay out-of-pocket, while still providing benefits for heart failure and chronic kidney disease management.

Eton Pharmaceuticals Launches FDA-Approved Galzin for Wilson Disease Maintenance Treatment

• Eton Pharmaceuticals has launched Galzin (zinc acetate) capsules, the only FDA-approved zinc therapy for Wilson disease maintenance treatment, offering improved access through their specialty pharmacy network. • The company introduces the Eton Cares Program, providing $0 co-pay for eligible patients and comprehensive support services, addressing historic availability and affordability challenges. • Through partnership with Optime Care specialty pharmacy, Eton aims to enhance treatment accessibility while investing in research for advancing Wilson disease therapeutics.

FDA Extends Review Period for Eton Pharmaceuticals' Rare Disease Drug ET-400

• The FDA has extended the PDUFA goal date for Eton Pharmaceuticals' ET-400 New Drug Application to May 28, 2025, requiring additional time to review supplemental information. • Eton Pharmaceuticals maintains confidence in their NDA package and does not expect the three-month extension to significantly impact their 2025 revenue projections. • The company, focused on rare disease treatments, currently markets seven commercial products and has four additional candidates in late-stage development.

Remedy Pharmaceuticals to Present CIRARA Data from Phase 3 CHARM Study at ISC 2025

• Remedy Pharmaceuticals will present efficacy data from the Phase 2 GAMES-RP and Phase 3 CHARM studies of CIRARA at the International Stroke Conference (ISC) 2025. • A meta-analysis will evaluate CIRARA's efficacy in treating Large Hemispheric Infarctions (LHI) with core lesion volumes ≤ 125 mL by combining data from GAMES-RP and CHARM trials. • Presentations will highlight CIRARA's potential to improve outcomes in LHI patients treated with endovascular therapy and examine 6 and 12-month outcomes from the CHARM trial. • An invited symposium will feature experts discussing advancements in understanding vascular permeability and cerebral edema post-stroke, emphasizing translating research into clinical practice.

Insulin Remains the Preferred Treatment for Gestational Diabetes

• A recent trial found that a sequential oral regimen of metformin and glyburide was not non-inferior to insulin in preventing large-for-gestational-age infants. • Maternal hypoglycemia was significantly higher in the oral medication group compared to the insulin group, raising concerns about safety. • The findings support the continued use of insulin as the primary pharmacological treatment for gestational diabetes, despite the convenience of oral alternatives. • Researchers suggest that while oral agents may reduce the need for insulin in some patients, insulin remains the most reliable option for glycemic control.

Eton Pharmaceuticals Acquires U.S. Rights to Amglidia for Neonatal Diabetes

• Eton Pharmaceuticals has acquired U.S. rights to Amglidia (glyburide oral suspension) from AMMTeK for treating neonatal diabetes mellitus. • Amglidia, already EMA-approved and available in Europe, addresses the unmet need for an FDA-approved oral treatment for this rare condition. • Eton plans to meet with the FDA in early 2025 and anticipates submitting an NDA for Amglidia in 2026, leveraging existing European safety and efficacy data. • The acquisition aligns with Eton's focus on pediatric endocrinology and expands its portfolio of treatments for rare diseases.

Glibenclamide Shows Promise in Improving Ambulation After Large Hemispheric Infarction

• Post-hoc analysis of the Phase 3 CHARM trial indicates that intravenous glibenclamide (CIRARA) significantly improves independent ambulation in patients with large hemispheric infarction (LHI). • Patients with lesion volumes under 125 mL treated with CIRARA showed a significantly higher odds ratio for achieving favorable modified Rankin Scale (mRS) scores. • CIRARA, when combined with endovascular thrombectomy (EVT), demonstrated a substantial increase in the ability of LHI patients to walk independently at 12 months. • Remedy Pharmaceuticals is planning a confirmatory Phase 3 study of CIRARA in LHI, encouraged by the sustained effects and impact on patient ambulation.
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