TheraRadar
Data updated: Jun 28, 2026

METFORMIN HYDROCHLORIDE

Trial Activity: Declining 122 active trials
Metabolic Approved 1995-03-03

1 INDICATIONS & USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Source: FDA Label • Teva
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Merck Sharp & Dohme LLC conducting 42 trials (5%)
481 indications explored (Broad Platform)
→ type 2 diabetes mellitus (113 trials)
→ diabetes mellitus, type 2 (109 trials)
→ healthy (49 trials)
87
Indications
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1995-03-03
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE, TABLET, SOLUTION

Companies

Teva WATSON LABS INC ZYDUS LIFESCIENCES PROVIDENT PHARM GLENMARK PHARMS LTD Sun Pharma REGCON HOLDINGS GRANULES HARMAN FINOCHEM UTOPIC PHARMS PHARMOBEDIENT IMPAX LABS CSPC OUYI Aurobindo Pharma WATSON LABS FLORIDA IVAX SUB TEVA PHARMS Novartis Apotex Lupin Viatris AARXION ANDA HLDING MICRO LABS LTD SCIEGEN PHARMS RANBAXY LABS LTD MARKSANS PHARMA ALKEM LABS LTD QINGDAO BAHEAL PHARM YICHANG HUMANWELL SENORES PHARMS Dr. Reddy's IPCA LABS LTD NOVAST LABS LTD PRINSTON INC AJANTA PHARMA LTD BIONPHARMA INDICUS PHARMA TORRENT PHARMS PLATINUM MACLEODS PHARMS LTD SUNSHINE ALIGNSCIENCE PHARMA LAURUS LABS LTD SAPTALIS PHARMS TWI PHARMS TORRENT HERITAGE PHARMA AMNEAL PHARMS NY MPP PHARMA CHARTWELL NOSTRUM PHARMS LLC ZYDUS PHARMS USA INVENTIA ZYDUS HLTHCARE VISTAPHARM LLC ANNORA PHARMA GRANULES INDIA UNICHEM EPIC PHARMA LLC
Active Ingredient: METFORMIN HYDROCHLORIDE

METFORMIN HYDROCHLORIDE Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
895 FDA actions from 2002 to 2026
Jun 2026 SUPPL
Label · Labeling
Jun 2026 SUPPL
Label · Labeling
Nov 2025 SUPPL
Mfg · Manufacturing (CMC)

What METFORMIN HYDROCHLORIDE Treats

87 FDA approvals

Originally approved for its first indication in 2002 . Covers 87 distinct patient populations.

  • Other (87)

METFORMIN HYDROCHLORIDE Boxed Warning

BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin­ associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (wit...

Teva's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

AJOVY
2018
FREMANEZUMAB-VFRM
1 designation
AUSTEDO
2017
DEUTETRABENAZINE
1 designation
CINQAIR
2016
RESLIZUMAB
1 designation
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Clinical Trial Registry

853 trials
Trial Sponsor ID Phase Status Title
NCT07585396 KFSIRB200-600 Ph 2, Ph 3 completed Inositol in Letrozol Resistant PCOS Women
NCT04545736 200163 20-EI-0163 Ph 1, Ph 2 active not recruiting Oral Metformin for Treatment of ABCA4 Retinopathy
NCT01329016 GDM 820 Ph 1, Ph 2 completed Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
NCT07530289 8507-018 MK-8507-018 Ph 1 completed A Clinical Study of Ulonivirine (MK-8507) With Atorvastatin and Metformin in Healthy Adults (MK-8507-018)
NCT02365597 results posted CR105065 42756493BLC2001, 2014-002408-26 Ph 2 active not recruiting An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer
NCT07226453 PNOC041 25087 NCI-2025-08332 Ph 2 recruiting Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma
NCT07570082 CRN04894-131 Ph 1 recruiting Drug-Drug Interaction Study of Atumelnant in Healthy Participants
NCT01762046 SUGAR-MGH results posted 2007p000193 Ph 1 completed Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
NCT07222098 1084-016 MK-1084-016 Ph 1 completed A Clinical Study of Calderasib (MK-1084) With Rosuvastatin and Metformin in Healthy People (MK-1084-016)
NCT07446400 359-201-00015 Ph 1 recruiting A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
NCT05093959 Met-PEF IRB00076663 U01AG076928 Ph 2 completed Metformin for Older Patients With Heart Failure With Preserved Ejection Fraction
NCT07567781 M25-744 Ph 1 recruiting A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
NCT06638671 HSR240014 Ph 4 completed Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
NCT06975111 25-0943 U1111-1322-1036 Ph 2, Ph 3 recruiting Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
NCT04742751 PREDM R21CA261713 Ph 2 active not recruiting An Open-Label Pilot Intervention Trial to Prevent Diabetes in Prediabetic Adult Survivors of Childhood Cancer
NCT07275359 INSPIRE-COPD-E Pro00116416 1K76AG095138-01 Ph 1 not yet recruiting Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
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
NCT04114136 HCC 18-190 Ph 2 recruiting Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies
NCT04510194 results posted GIM-2020-29324 Ph 3 completed COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
NCT05768139 PIKALO-1 27691 2023-504807-94-00, 2023-000442-41 Ph 1, Ph 2 recruiting First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT04264897 ANTHEM 10699 R01AG064951 Ph 3 completed Antecedent Metabolic Health and Metformin Aging Study
NCT06829238 (MET-IH) 000543853 1R01DA060692-01A1 Ph 4 recruiting Assessment of Metformin for Restoration of Immune Homeostasis in HIV+ and HIV- Individuals With a History of Injection Drug Use
NCT02874430 results posted 16D.317 JT 8988 Ph 2 terminated Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
NCT07541456 EMPA-BP SIMC-IM-EMPA-BP-RCT-2025-01 Ph 4 completed Empagliflozin Versus Non-SGLT2 Oral Drugs for Blood Pressure in Type 2 Diabetes
NCT03054519 PERMET STU00203784 Ph 3 completed Improve PAD PERformance With METformin
NCT07531108 05022025-2-2 Ph 4 completed Effects of Empagliflozin-Metformin, Sitagliptin-Metformin, and Metformin on Adipokines in Type 2 Diabetes
NCT04530383 STUDY00146063/STUDY00161734 R01HL157942-01 Ph 2 recruiting Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
NCT07520110 MAVRIC STUDY00002828 PR241441 Ph 3 not yet recruiting Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis
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
NCT05366868 004371 jRCTs051180211 Ph 4 active not recruiting Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
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)
NCT07001878 73219 Ph 4 recruiting Cannabis Potency Effects on Brain White Matter in Early Phase Psychosis
NCT05744479 METIDD 024/2022 Ph 4 recruiting Metformin for Antipsychotic-induced Weight Gain in Adults With Intellectual Disability
NCT02437656 METCAP METCAP-1404 2014-003687-20 Ph 2 completed Combination of Metformin to Neoadjuvant Radiochemotherapy in the Treatment of Locally Advanced Rectal Cancer.
NCT07502001 HDM1005-104 Ph 1 not yet recruiting Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
NCT06679413 UP0132 Ph 1 completed A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
NCT05900466 00160543 R21AR082574 Ph 2 recruiting Metformin for Fibromyalgia Symptoms (INFORM Trial)
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
NCT07223671 CA127-1088 Ph 1 completed Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
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
NCT07485764 2025Lunshenzi(0610-03) Ph 4 not yet recruiting Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients
NCT03499704 EPIDOTE Alogliptin-Pio-4001 U1111-1207-8037 Ph 4 completed A Study to Evaluate the Effect of add-on Pioglitazone or Dapagliflozin in Participants With Type 2 Diabetes Mellitus Inadequately Controlled by DPP-4 Inhibitor and Metformin Therapy
NCT07045142 WU202505STA Ph 3 recruiting Metformin Alleviates Abnormal Glucose Metabolism Induced by Statins in Schizophrenia Patients
NCT03424005 Morpheus-panBC CO40115 2017-002038-21, 2023-503629-20-00 Ph 1, Ph 2 recruiting A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
NCT07475546 ALRx011 Ph 3 active not recruiting Combination Gerotherapeutic Interventions for Healthspan Improvement
NCT06231758 Menofya 1247 Ph 3 recruiting Metformin Safety and Efficacy in Osteoarthritis.
NCT05781711 3-2023 Ph 2 completed Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease
NCT01351753 REVIVE results posted 201012738 Ph 2 terminated Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Showing 50 of 853 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.

METFORMIN HYDROCHLORIDE FDA Label Details

Indications & Usage

FDA Label (PDF)

1 INDICATIONS & USAGE Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

⚠️ BOXED WARNING

BOXED WARNING WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin­ associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as ma...

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Data Sources

FDA Approval: ANDA076496 → Label: DailyMed → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment