Diabeta

(Glyburide)

ApprovedSmall molecule

Diabeta is a small molecule that works as a Sulfonylurea Receptor 1, Kir6.2 Blocker.[2] It is being used across 13 indications, with its most advanced program in Approved.[1]

Diabeta is one of 395 small molecule programs targeting Gestational Diabetes. It is currently in Approved.

Indications

Total Trials

Active Trials

394

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Gestational DiabetesApproved

StrokeApproved

Insulin SecretionActive, not recruiting

Angina PectorisApproved

Type 2 Diabetes MellitusActive, not recruiting

Brain InjuryActive, not recruiting

Congestive Heart FailureActive, not recruiting

Intracerebral HemorrhageActive, not recruiting

Diabetes MellitusActive, not recruiting

Type 2 DiabetesActive, not recruiting

Gestational DiabetesApproved

Approved

StrokeApproved

Approved

Insulin SecretionPreclinical

Active, not recruiting

Angina PectorisApproved

Approved

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Brain InjuryPhase 2

Active, not recruiting

Congestive Heart FailurePhase 3

Active, not recruiting

Intracerebral HemorrhagePreclinical

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Type 2 DiabetesPhase 3

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Diabeta

Pfizer

Approved

7 2

Byetta

AstraZeneca

Preclinical

55 3

NOVOLIN R

Novo Nordisk

Preclinical

5 4

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 5

Aurlumyn

BBTG International Inc.

Preclinical

1 6

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 7

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 8

Forxiga

AstraZeneca

Preclinical

3 9

Lovaza

AstraZeneca

Preclinical

1 10

Sulfonylureas

Eli Lilly

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 1Recruiting

Spinal Cord Injury

NCT05426681

Clinical

Trials by Indication[1]

Gestational Diabetes8 trials

Glyburide Compared to Insulin in the Management of White's Classification A2 Gestational Diabetes

Withdrawn·—·Phase 4·NCT00160485

Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

Unknown status·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1/2·NCT01329016·360 enrolled

Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00744965·395 enrolled

Show 5 more trials

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Completed·—·Phase 4·NCT03029702·54 enrolled

Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes

Not yet recruiting·—·N/A·NCT06589141·180 enrolled

Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Withdrawn·UUniversity of Pittsburgh·Phase 4·NCT01947699

Metformin Compared to Glyburide in Gestational Diabetes

Completed·UUniversity of New Mexico·N/A·NCT00965991·149 enrolled

Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01731431·914 enrolled

Type 2 Diabetes7 trials

A Research Study to Determine the Safety and Efficacy of Glucovance Compared to Metformin and Glyburide in Children and Adolescents With Type 2 Diabetes.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00035542

Effect of GlucoNorm vs Glyburide on Post-Prandial Hyperglycemia in Elderly Subjects With Type 2 Diabetes

Completed·UUniversity of British Columbia·Phase 2·NCT00451620·30 enrolled

A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

Completed· Roche logo

Roche·Phase 1·NCT00388986·18 enrolled

Show 4 more trials

Effect of Repaglinide on Postprandial Lipemia in Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01605773·51 enrolled

Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Completed· Novo Nordisk logo

Novo Nordisk·Phase 4·NCT01698931·9 enrolled

A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00313313·768 enrolled

Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes

Completed·UUniversity of Michigan·N/A·NCT00549874·27 enrolled

Type 2 Diabetes Mellitus6 trials

Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.

Terminated· Takeda logo

Takeda·Phase 3·NCT00759720·447 enrolled

A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus

Terminated· Eli Lilly logo

Eli Lilly·Phase 2·NCT01029795·38 enrolled

Efficacy of Pioglitazone Compared to Glyburide in Treating Subjects With Type 2 Diabetes Mellitus and Mild Cardiac Disease

Completed· Takeda logo

Takeda·Phase 3·NCT00521742·300 enrolled

Show 3 more trials

Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT00232583·58 enrolled

Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.

Completed· Takeda logo

Takeda·Phase 3·NCT00286468·500 enrolled

Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus

Unknown status·—·Phase 1·NCT01319734·50 enrolled

Treatment3 trials

Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

Completed· Sanofi logo

Sanofi·Phase 3·NCT00046462·240 enrolled

Glyburide vs Glucovance in the Treatment of GDM

Terminated·TTexas Tech University Health Sciences Center, El Paso·Phase 1·NCT02726490·7 enrolled

Preferred Treatment of Type 1.5 Diabetes

Completed·UUniversity of Washington·N/A·NCT00194896·64 enrolled

Type 2 Diabetic Patients2 trials

Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients

Completed·SSt. Paul Heart Clinic·Phase 4·NCT00123643·36 enrolled

Insulin Glargine in Type 2 Diabetic Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00347100·387 enrolled

15 more indications

Spinal Cord Injury2 trials

Spinal Cord Injury Neuroprotection With Glyburide

Terminated·OOhio State University·Phase 1/2·NCT02524379·3 enrolled

Spinal Cord Injury Neuroprotection With Glyburide

Recruiting·FFrancis Farhadi·Phase 1·NCT05426681·12 enrolled

Metformin1 trial

Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Withdrawn·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03078725

Female1 trial

Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02183428·20 enrolled

Pregnancy1 trial

Oral Antidiabetic Agents in Pregnancy

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT02091336·80 enrolled

Polyp1 trial

Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)

Withdrawn·UUniversity of California, San Francisco·Phase 1·NCT00935363

Insulin Secretion1 trial

Glimepiride Induced Insulin Secretion Will be Inhibited by Hypoglycemia

Completed·VVanderbilt University·N/A·NCT00608179·32 enrolled

Congestive Heart Failure1 trial

Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure

Terminated· Takeda logo

Takeda·Phase 3·NCT00521820·518 enrolled

Tics1 trial

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01733108·29 enrolled

Interaction1 trial

The Drug -Drug Interaction of SP2086 and Glyburide

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02815787·16 enrolled

Function1 trial

Safety Study of Pioglitazone Compared To Glyburide on Liver Function

Completed· Takeda logo

Takeda·Phase 4·NCT00494312·2,120 enrolled

Monotherapy1 trial

Diabetes Study With Rosiglitazone Monotherapy Versus Metformin Or Glyburide/Glibenclamide

Completed· GSK logo

GSK·Phase 3·NCT00279045·4,426 enrolled

Brain Injury1 trial

Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

Completed·RRemedy Pharmaceuticals, Inc.·Phase 2·NCT01454154·29 enrolled

Adult1 trial

Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

Completed·IIronwood Pharmaceuticals, Inc.·Phase 1·NCT03856970·87 enrolled

Brain Metastases1 trial

Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593)

Terminated·UUniversity of Alabama at Birmingham·Phase 1/2·NCT02460874·1 enrolled

Unspecified2 trials

Glyburide Healthy Volunteer Study

Completed·WWashington University School of Medicine·Phase 1·NCT01716338·21 enrolled

R230C and C230C Variants of ABCA1 and Glyburide Response

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 4·NCT01456650·85 enrolled

Regulatory

FDA Approval Timeline[4]

May 1, 1984

DIABETA

NDA NDA017532

May 1, 1984

MICRONASE

NDA NDA017498

Mar 4, 1992

GLYNASE

NDA NDA020051

Apr 17, 1992

GLYBURIDE (MICRONIZED)

NDA NDA020055

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Glyburide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glyburide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glyburide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020055). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sulfonylurea Receptor 1, Kir6.2 Blocker[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Pfizer

Diabeta

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

Gestational Diabetes8 trials

Type 2 Diabetes7 trials

Type 2 Diabetes Mellitus6 trials

Treatment3 trials

Type 2 Diabetic Patients2 trials

Spinal Cord Injury2 trials

Metformin1 trial

Female1 trial

Pregnancy1 trial

Polyp1 trial

Insulin Secretion1 trial

Congestive Heart Failure1 trial

Tics1 trial

Interaction1 trial

Function1 trial

Monotherapy1 trial

Brain Injury1 trial

Adult1 trial

Brain Metastases1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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