Metformin XR

ApprovedSmall molecule

AstraZeneca

Metformin XR is one of 181 small molecule programs targeting Type 2 Diabetes Mellitus. It is currently in Approved.

Indications

Total Trials

Active Trials

180

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type 2 Diabetes MellitusActive, not recruiting

Polycystic Kidney DiseaseActive, not recruiting

Polycystic Ovary SyndromeActive, not recruiting

Breast CancerActive, not recruiting

Multiple MyelomaActive, not recruiting

Type 2 DiabetesActive, not recruiting

ObesityActive, not recruiting

Polycystic Ovarian Syndrome (PCOS)Completed

Type 2 Diabetes (T2DM)Not yet recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

Polycystic Kidney DiseasePhase 3

Active, not recruiting

Polycystic Ovary SyndromePhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Multiple MyelomaPhase 2

Active, not recruiting

Type 2 DiabetesApproved

Active, not recruiting

ObesityApproved

Active, not recruiting

Polycystic Ovarian Syndrome (PCOS)Phase 1

Completed

Type 2 Diabetes (T2DM)Phase 2

Not yet recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Metformin XR

AstraZeneca

Approved

1 2

Tecentriq

Roche

Preclinical

36 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Zinecard

CChildren's Oncology Group

Preclinical

2 5

Chirocaine

PPurdue Pharma LP

Preclinical

1 6

Cortef

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

Preclinical

1 7

Avastin

Roche

Preclinical

4 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Polycystic Kidney Disease

NCT04939935

Q3 2027

Phase 2Active, not recruiting

Multiple Myeloma

NCT04850846

Q4 2027

Phase 2Not yet recruiting

Type 2 Diabetes (T2DM)

NCT07139405

Q3 2029

Post-ApprovalRecruiting

Cardiovascular

NCT02915198

Clinical

Trials by Indication[1]

Metformin11 trials

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02065752·2 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02077803·47 enrolled

A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01755494·64 enrolled

Show 8 more trials

Study To Evaluate 24 Hour Blood Sugar Control (24-hour Mean Weighted Glucose) In Subjects That Are Taking Saxagliptin 5 mg Added Onto Metformin XR 1500 XR mg Compared To Subjects Taking Metformin XR 1500 mg Up-titrated To Metformin XR 2000 mg

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00918138·219 enrolled

A Study to Compare MP-513 20mg & Metformin XR 1000mg FDC With Coadministration of the Two Separate Drugs

Completed·HHandok Inc.·Phase 1·NCT03787017·36 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02073227·52 enrolled

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02071368·3 enrolled

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both

Completed·DDexa Medica Group·Phase 3·NCT01999686·186 enrolled

An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00643851·994 enrolled

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01192139·30 enrolled

BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 1·NCT01305551

Type 2 Diabetes7 trials

Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia

Completed·CCook County Health·Phase 4·NCT01267448·100 enrolled

Phase 4: Investigational Study to Evaluate Metformin XR Monotherapy Versus Metformin IR Monotherapy in Subjects With Type 2 Diabetes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01864174·1,736 enrolled

An 18 Week Efficacy and Safety Study of Saxagliptin and Metformin XR Combination in Subjects With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00960076·282 enrolled

Show 4 more trials

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT02252965·532 enrolled

Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00859898·1,093 enrolled

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01434186·32 enrolled

Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01606007·1,282 enrolled

Multiple Myeloma2 trials

Clinical Activity of Metformin With High-dose of Dexamethasone in Relapse Multiple Myeloma

Unknown status·UUniversity of Campinas, Brazil·Phase 2·NCT02967276·28 enrolled

Investigation of Metformin for the Prevention of Progression of Precursor Multiple Myeloma

Active, not recruiting·—·Phase 2·NCT04850846·60 enrolled

Polycystic Ovary Syndrome2 trials

Treatment of Infertility in Women With Polycystic Ovary Syndrome

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00068861·678 enrolled

Efficacy and Safety of DLBS3233 in Subjects With Polycystic Ovary Syndrome (PCOS)

Completed·DDexa Medica Group·Phase 3·NCT01733459·124 enrolled

Type 2 Diabetes Mellitus2 trials

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01809327·1,186 enrolled

A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01760447·223 enrolled

13 more indications

Polycystic Ovarian Syndrome (PCOS)2 trials

Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome

Completed·JJinnah Postgraduate Medical Centre·Phase 1·NCT07399535·116 enrolled

Effect of Nepeta Adenophyta Hedge Extract and Its Fractions on Polycystic Ovarian Syndrome (PCOS)

Completed·JJinnah Sindh Medical University·Phase 1·NCT07603505·116 enrolled

Polycystic Kidney Disease1 trial

Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)

Recruiting·TThe University of Queensland·Phase 3·NCT04939935·1,174 enrolled

Body Weight1 trial

Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00778622·371 enrolled

Patients With Advanced Solid Tumors1 trial

A Pharmacodynamic Study of Sirolimus and Metformin in Patients With Advanced Solid Tumors

Completed·UUniversity of Chicago·Phase 1·NCT02145559·24 enrolled

Concentration1 trial

Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT01525225·4 enrolled

Homeostasis1 trial

Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis

Completed·WWoman's·Phase 3·NCT02022007·38 enrolled

Cardiovascular1 trial

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Recruiting·VVA Office of Research and Development·Phase 4·NCT02915198·7,410 enrolled

Dapagliflozin1 trial

Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01002807·15 enrolled

Obesity1 trial

Effect of Dapagliflozin/Metformin XR vs Monotherapies on Anthropometric Indicators in Obesity

Unknown status·UUniversity of Guadalajara·Phase 4·NCT03710460·33 enrolled

Randomized1 trial

Randomized Sitagliptin Withdrawal Study (MK-0431-845)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02738879·746 enrolled

ART1 trial

A Study of LY900020 in Healthy Chinese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04047940·32 enrolled

Breast Cancer1 trial

Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant

Terminated· Novartis logo

Novartis·Phase 2·NCT04899349·2 enrolled

Type 2 Diabetes (T2DM)1 trial

A Double-Blind, Randomized, Active-Controlled Phase 2a Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TriGlytza®-01 in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy

Not yet recruiting·MMyopharm Limited·Phase 2·NCT07139405·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Metformin XR. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Metformin XR compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Metformin XR. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AstraZeneca

Metformin XR

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q3 2029

Trials by Indication[1]

Metformin11 trials

Type 2 Diabetes7 trials

Multiple Myeloma2 trials

Polycystic Ovary Syndrome2 trials

Type 2 Diabetes Mellitus2 trials

Polycystic Ovarian Syndrome (PCOS)2 trials

Polycystic Kidney Disease1 trial

Body Weight1 trial

Patients With Advanced Solid Tumors1 trial

Concentration1 trial

Homeostasis1 trial

Cardiovascular1 trial

Dapagliflozin1 trial

Obesity1 trial

Randomized1 trial

ART1 trial

Breast Cancer1 trial

Type 2 Diabetes (T2DM)1 trial

References

Drug Info

Quick Facts

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