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Data updated: May 26, 2026

RIOMET ER (metformin hydrochloride)

Metabolic Approved 2019-08-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Discontinued
First Approved
2019-08-29
Patent Cliff
2035

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Routes
ORAL
Dosage Forms
FOR SUSPENSION, EXTENDED RELEASE

Companies

Sun Pharma
Active Ingredient: METFORMIN HYDROCHLORIDE

RIOMET ER Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Aug 2019 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What RIOMET ER Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • Other (1)
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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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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.

RIOMET ER FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 3 international docs across 1 countries

RIOMET ER Patents & Exclusivity

Latest Patent: May 2035

Patents (1 active)

US9962336 Expires May 1, 2035
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2035
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA212595 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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