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Data updated: May 26, 2026

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE (metformin hydrochloride)

Metabolic Approved 2014-05-07
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2014-05-07
Routes
ORAL
Dosage Forms
TABLET

Companies

Teva
Active Ingredient: METFORMIN HYDROCHLORIDE , ROSIGLITAZONE MALEATE

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2014 to 2017
May 2017 ORIGINAL
Update
Label
Apr 2017 SUPPL
Label · Labeling
FDA Letter
May 2014 ORIGINAL
Update
FDA Letter Label

What ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE Treats

2 FDA approvals

Originally approved for its first indication in 2014 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

72 trials
Trial Sponsor ID Phase Status Title
NCT04545736 200163 20-EI-0163 Ph 1, Ph 2 recruiting Oral Metformin for Treatment of ABCA4 Retinopathy
NCT06638671 HSR240014 Ph 4 active not recruiting Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
NCT01905046 results posted A211102 U10CA031946, NCI-2013-00995 Ph 3 active not recruiting Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
NCT02874430 results posted 16D.317 JT 8988 Ph 2 terminated Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
NCT04530383 STUDY00146063/STUDY00161734 R01HL157942-01 Ph 2 recruiting Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
NCT07368569 1434-0005 2025-522432-14, U1111-1322-9764 Ph 1 completed A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
NCT02581137 results posted NCI-2015-01733 NCI-2015-01733, HHSN2612012000311 Ph 2 active not recruiting Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion
NCT05445791 METLUNG (020/023/ICI) (CEI/1421/19) Ph 3 recruiting Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
NCT03514108 DANHEART DANHEART 2015-002150-12 Ph 4 completed DANHEART (H-HeFT and Met-HeFT)
NCT02122185 results posted IRB13-1235 NCI-2014-00860, IRB13-1235 Ph 2 completed Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT06899061 D9723C00002 2024-513692-41-00 Ph 1 active not recruiting Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
NCT06611501 GREAT IRB-P00049391 Ph 2 recruiting Glycemic Regulation as Endometriosis Adjunct Treatment
NCT07387900 OMED 3.7.2 Ph 2 recruiting Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
NCT02336087 14122 NCI-2014-02612, 14122 Ph 1 active not recruiting Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery
NCT03076281 results posted 16D.703 JT 9611 Ph 2 terminated Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
NCT06504862 results posted 1479-0015 2024-510628-38-00, U1111-1302-1171 Ph 1 completed A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
NCT04221750 DEMFOS ENDA-007-19F H-46970 Ph 3 completed Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
NCT03109847 results posted 16D.564 JT 9411 Ph 2 terminated Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers
NCT05680805 BSMMU/2022/9559-768 Ph 4 active not recruiting Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS
NCT06707012 frpmc.edu.pk@sadiakhan12345678 FMC, University Ph 4 recruiting Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
NCT06920056 BGM0504-DDI Ph 1 completed A Study of BGM0504 in Overweight or Obese Participants
NCT01430351 2011-0374 NCI-2011-03038, 2011-0374 Ph 1 terminated Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy
NCT06332612 MROSF 8420224AROM Ph 1, Ph 2 completed Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial
NCT02339168 680462 UCDCC#243, UCDCC#243 Ph 1 completed Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer
NCT05828303 CA127-1027 Ph 1 withdrawn A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
NCT02980276 EMERGE results posted NUIG-2016-01 Ph 3 completed RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
NCT06655220 1485-0013 2024-515911-23-00, U1111-1306-9403 Ph 1 completed A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body
NCT05607316 STUDY00000630 Ph 2 withdrawn Evaluating the Efficacy and Safety of Metformin in Vitiligo
NCT03829020 MC1811 NCI-2019-00466, MC1811 Ph 1 completed Metformin, Nelfinavir, and Bortezomib in Treating Patients With Relapsed and/or Refractory Multiple Myeloma
NCT03331861 Met-HeFT results posted AAAR5389 Ph 2 terminated Metformin in Heart Failure Without Diabetes
NCT04807348 CGZ303 Ph 3 completed Chiglitazar Added to Metformin for Type 2 Diabetes
NCT03733132 results posted 18-004012 1R21AG060139-01 Ph 2 completed Metformin Effect on Brain Function in Insulin Resistant Elderly People
NCT06452498 PI-NL PI-NL trial 2023-510382-10-00 Ph 3 not yet recruiting Preeclampsia Intervention Netherlands
NCT04267809 Met-YF-001 Ph 2 completed Modulate Cellular Stress in the Immune Cells to Reduce Rate of Symptomatic Viral Infection
NCT04593459 ProPCO-RCT 160120200001 2020-000228-20 Ph 4 completed Probiotic Intervention in PCOS
NCT05590676 3987 Ph 1 terminated Metformin Treatment in Infants After Perinatal Brain Injury
NCT06170463 ZU-IRB#11195-21/6-2023 Ph 1 completed Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
NCT02854527 results posted 352.2096 2016-001893-14 Ph 1 completed Transporter Cocktail Mutual Interaction
NCT02231931 352.2082 2014-001940-40 Ph 1 completed Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
NCT02068443 results posted SYR-322-MET/CCT-001 JapicCTI-132377, U1111-1151-6515 Ph 3 completed Comparative Study to Evaluate Efficacy and Safety When Metformin Hydrochloride 500 mg Once Daily is Added on to SYR-322 25 mg in Type 2 Diabetic Patients With Inadequate Glycemic Control Despite Treatment With SYR-322 25 mg in Addition to Diet and Exercise Therapy
NCT01101438 results posted MA32 U10CA077202, CAN-NCIC-MA.32 Ph 3 completed A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
NCT06012682 METIN 2021/ABM/03/00006 Ph 2 not yet recruiting Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
NCT04758000 Metform-Bone 794/2020/Farm/IOR 2020-002579-37 Ph 2 recruiting Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
NCT05177588 CL (2582) Ph 4 completed Efficacy of Metformin as add-on Therapy in Non-Diabetic Heart Failure Patients
NCT05768360 D5084C00014 2022-003785-21 Ph 1 completed A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects
NCT02420652 PRIMA results posted 081501 NCI-2015-00397, Pro20150001378 Ph 2 terminated Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy
NCT05451147 N.F.5(283)/2013-CO Ph 3 completed A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)
NCT03359681 MECORA REG-096-2017 Ph 2 completed Metformin Treatment for Colon Cancer
NCT01666730 results posted CASE1212 Ph 2 completed Metformin Plus Modified FOLFOX 6 in Metastatic Pancreatic Cancer
NCT04943692 COMETII SIL-30000-III-19(1) Ph 3 suspended Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes

Showing 50 of 72 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA077337 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.