Primary completion· ClinicalTrials.gov
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients W
Canagliflozin History and Updates
237 events · 2002 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
464
FDA Approvals
82
Label Revisions
954
Trial Milestones
2
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-18Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Canagliflozin since 2002, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (57)
2026
- Label revisionMetformin Hydrochloride ER Label Receives Boxed Warning for Lactic Acidosis· Jun 9, 2026
- Label revisionMetformin Hydrochloride Boxed Warning Revised for Lactic Acidosis· Jun 9, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jun 8, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 27, 2026
- Label revisionMetformin Hydrochloride Label Updated with Boxed Warning for Lactic Acidosis· May 22, 2026
- Label revisionMetformin Hydrochloride Extended Release Label Adds Boxed Warning for Lactic…· May 22, 2026
- Label revisionCanagliflozin: Metformin-Associated Lactic Acidosis Boxed Warning Updated· May 21, 2026
- Label revisionMetformin Hydrochloride Label Updated with Boxed Warning for Lactic Acidosis· May 21, 2026
- Label revisionMetformin Hydrochloride Label Revised: Boxed Warning on Lactic Acidosis Updated· May 19, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 18, 2026
- Label revisionMetformin Hydrochloride Label Receives Boxed Warning for Lactic Acidosis· May 13, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 11, 2026
- Label revisionMetformin Hydrochloride Label Updated with Lactic Acidosis Boxed Warning· May 8, 2026
- Label revisionGlyburide and Metformin Hydrochloride Label Receives Lactic Acidosis Boxed…· May 7, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 7, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 6, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· May 5, 2026
- Results postedMetformin Hydrochloride & Doxycycline Trial for Breast/Uterine Cancer Terminated· Apr 22, 2026
- Label revisionMetformin Hydrochloride Label Receives New Boxed Warning for Lactic Acidosis· Apr 16, 2026
- Results postedMetformin Hydrochloride Trial for Ovarian Cancer Shows No Significant PFS or…· Mar 27, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Mar 18, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Feb 10, 2026
- Label revisionInvokamet XR Label Adds Boxed Warning for Metformin-Associated Lactic Acidosis· Jan 31, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jan 29, 2026
- Results postedMetformin/Doxycycline Head and Neck Squamous Cell Carcinoma Trial Results Posted· Jan 29, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jan 28, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jan 14, 2026
- Results postedZongertinib Alters Pharmacokinetics of Dabigatran, Rosuvastatin, and Metformin· Jan 9, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jan 1, 2026
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jan 1, 2026
2025
- Label revisionMetformin HCl Label Updated for Type 2 Diabetes Mellitus Indication· Dec 26, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Dec 18, 2025
- Results postedMetformin Trial for Thyroid Cancer Sequelae Shows No Significant RBC Benefit· Dec 11, 2025
- Label revisionMetformin Hydrochloride Label Updates Indication and Usage· Dec 5, 2025
- FDA approvalSitagliptin And Metformin Hydrochloride Receives Initial FDA Approval· Dec 2, 2025
- Label revisionInvokamet XR Label Adds Boxed Warning for Metformin-Associated Lactic Acidosis· Dec 1, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Oct 28, 2025
- Label revisionMetformin Hydrochloride Label Updated with Lactic Acidosis Boxed Warning· Oct 15, 2025
- Label revisionGlipizide and Metformin Hydrochloride Label Receives Boxed Warning for Lactic…· Oct 14, 2025
- Label revisionMetformin Label Updated with New Indication for Type 2 Diabetes· Aug 22, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Aug 18, 2025
- Label revisionMetformin Hydrochloride Label Updated with Boxed Warning for Lactic Acidosis· Aug 6, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Aug 6, 2025
- Primary completionCanagliflozin: Phase 3 Metformin Trial for Frailty in Obese Seniors Completes· Jul 31, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jun 30, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Jun 18, 2025
- Label revisionCanagliflozin: Boxed Warning Added to ZITUVIMET Label for Lactic Acidosis Risk· Jun 9, 2025
- Label revisionMetformin Hydrochloride Label Adds Boxed Warning for Lactic Acidosis· Apr 23, 2025
- FDA approvalMetformin Hydrochloride Oral Solution Receives FDA Approval· Apr 14, 2025
- Results postedMetformin Hydrochloride Shows No Significant Difference in Preventing Breast…· Apr 13, 2025
- Label revisionAlogliptin and Metformin Hydrochloride Label Adds Lactic Acidosis Boxed Warning· Apr 11, 2025
- Label revisionMetformin Hydrochloride Extended Release Label Adds Boxed Warning for Lactic…· Mar 26, 2025
- Results postedMetformin Reduces Insulin Need in Gestational Diabetes Phase 3 Trial· Mar 17, 2025
- FDA approvalMetformin Hydrochloride Receives Initial FDA Approval as Generic· Mar 13, 2025
- Results postedCanagliflozin Reduces HbA1c in Pediatric Type 2 Diabetes Mellitus· Mar 12, 2025
2019
- Pivotal publicationCanagliflozin CREDENCE Trial Results Published for Diabetic Nephropathy· Jan 1, 2019
2013
- Pivotal publicationCanagliflozin: 52-Week Efficacy, Safety Results vs Glimepiride in Type 2…· Jan 1, 2013
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer
Primary completion· ClinicalTrials.gov
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Primary completion· ClinicalTrials.gov
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Primary completion· ClinicalTrials.gov
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Primary completion· ClinicalTrials.gov
Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations
Primary completion· ClinicalTrials.gov
Danish Precocious Puberty Study - DAPP Study A National Cohort Study on Incidence and Etiologies for Precocious Puberty
Primary completion· ClinicalTrials.gov
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Primary completion· ClinicalTrials.gov
Pilot Study on Evaluating the Geroprotective Effect of Metformin
Primary completion· ClinicalTrials.gov
Canagliflozin With Gemcitabine in Pancreatic Carcinoma
Primary completion· ClinicalTrials.gov
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
Primary completion· ClinicalTrials.gov
Renal Mechanism of SGLT2 Inhibition
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
Primary completion· ClinicalTrials.gov
Canagliflozin Targeting Vascular Inflammation
Primary completion· ClinicalTrials.gov
Metformin for Chemoprevention of Lung Cancer in Overweight or Obese Individuals at High Risk for Lung Cancer
Primary completion· ClinicalTrials.gov
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
Primary completion· ClinicalTrials.gov
CANagliflozin In DIALysis Patients
Primary completion· ClinicalTrials.gov
Glycemic Regulation as Endometriosis Adjunct Treatment
Primary completion· ClinicalTrials.gov
Metformin Add-on Clinical Study in Multiple Sclerosis to Evaluate Brain Remyelination And Neurodegeneration
Primary completion· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Primary completion· ClinicalTrials.gov
Metformin as Maintenance Therapy in Patients With Bone Sarcoma and High Risk of Relapse
Primary completion· ClinicalTrials.gov
The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
Primary completion· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
Primary completion· ClinicalTrials.gov
SGLT2 Inhibitor Utilization Re-perfusion Therapy
Primary completion· ClinicalTrials.gov
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Primary completion· ClinicalTrials.gov
Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
Primary completion· ClinicalTrials.gov
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
Primary completion· ClinicalTrials.gov
Oral Metformin for Treatment of ABCA4 Retinopathy
Primary completion· ClinicalTrials.gov
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
Primary completion· ClinicalTrials.gov
Canagliflozin in Advanced Renal Disease With MRI Endpoints
Primary completion· ClinicalTrials.gov
Preeclampsia Intervention Netherlands
Primary completion· ClinicalTrials.gov
Evaluating the Efficacy and Safety of Metformin in Vitiligo
Primary completion· ClinicalTrials.gov
Oral Metformin for Treatment of ABCA4 Retinopathy
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Primary completion· ClinicalTrials.gov
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Primary completion· ClinicalTrials.gov
Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
Past events
2026
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
INDICATIONS AND USAGE Glipizide and metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Label revision· FDA
1 INDICATIONS AND USAGE INVOKANA (canagliflozin) is indicated: as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. to reduce the risk of majo
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accom
Label revision· FDA
WARNING: LACTIC ACIDOSIS Post-marketing 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, accom
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accom
Label revision· FDA
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
Label revision· FDA
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accomp
Label revision· FDA
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
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Trial started· ClinicalTrials.gov
CANagliflozin In DIALysis Patients
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Krill Oil and Metformin in Women With PCOS and Metabolically Unhealthy Obesity
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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
Label revision· FDA
Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
Boxed warning present on label on glyburide and metformin hydrochloride label (effective 2026-05-21)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
FDA approval (supplemental)· FDA
Sponsor: SUN PHARM. Class: Manufacturing (CMC).
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accom
Label revision· FDA
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, accomp
Label revision· FDA
Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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, accomp
Label revision· FDA
Boxed warning present on label on Glyburide and Metformin Hydrochloride label (effective 2026-05-07)
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompa
Label revision· FDA
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
Label revision· FDA
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, accom
Trial registered· ClinicalTrials.gov
Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Localized Breast or Uterine Cancer
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
CANagliflozin In DIALysis Patients
Trial started· ClinicalTrials.gov
SGLT2 Inhibitor Utilization Re-perfusion Therapy
Trial started· ClinicalTrials.gov
Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)
FDA approval· FDA
Sponsor: ALKEM LABS LTD.
FDA approval· FDA
Sponsor: LUPIN.
FDA approval· FDA
Sponsor: SUN PHARM.
FDA approval· FDA
Sponsor: AUROBINDO PHARMA.
FDA approval· FDA
Sponsor: MSN.
FDA approval· FDA
Sponsor: MACLEODS PHARMS LTD.
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Canagliflozin in Advanced CKD
Results posted· ClinicalTrials.gov
Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Primary completion· ClinicalTrials.gov
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Trial started· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Trial started· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis
Label revision· FDA
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, accomp
Trial started· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Trial started· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Trial registered· ClinicalTrials.gov
Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia
Primary completion· ClinicalTrials.gov
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Trial registered· ClinicalTrials.gov
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
Trial started· ClinicalTrials.gov
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
Results posted· ClinicalTrials.gov
Metformin Hydrochloride and Doxycycline in Treating Patients With Head and Neck Squamous Cell Carcinoma
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Trial registered· ClinicalTrials.gov
A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Mida
Trial registered· ClinicalTrials.gov
A Study in Healthy People to Test Whether BI 764198 Influences the Amount of Metformin in the Body
Label revision· FDA
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, accomp
Results posted· ClinicalTrials.gov
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furo
Label revision· FDA
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, accomp
Label revision· FDA
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, accomp
2025
Primary completion· ClinicalTrials.gov
DANHEART (H-HeFT and Met-HeFT)
Primary completion· ClinicalTrials.gov
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis
Primary completion· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Label revision· FDA
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Trial registered· ClinicalTrials.gov
Metformin Hydrochloride in Combination With Standard of Care Systemic Therapy in Previously Untreated Advanced Unresectable or Metastatic So
Label revision· FDA
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, accom
Results posted· ClinicalTrials.gov
Metformin to Mitigate Sequelae of Radioactive Iodine Treatment for Thyroid Cancers
Primary completion· ClinicalTrials.gov
Metformin and Nightly Fasting in Women With Early Breast Cancer
Label revision· FDA
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Trial registered· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
FDA approval· FDA
Sponsor: SANDOZ.
Primary completion· ClinicalTrials.gov
Efficacy of Vildagliptin Versus Metformin in Poly Cystic Ovary Syndrome
Label revision· FDA
WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradya
Primary completion· ClinicalTrials.gov
Metabolic Responses of Metformin and Genetic Polymorphisms of SLC22A1 Gene in PCOS
Primary completion· ClinicalTrials.gov
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
FDA approval (supplemental)· FDA
Sponsor: GRANULES INDIA. Class: Manufacturing (CMC).
Primary completion· ClinicalTrials.gov
Metformin for the Prevention of Oral Cancer in Patients With Oral Leukoplakia or Erythroplakia
FDA approval· FDA
Sponsor: MSN.
Label revision· FDA
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, accomp
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Labeling.
Label revision· FDA
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, accomp
Label revision· FDA
Boxed warning present on label on Glipizide and Metformin Hydrochloride label (effective 2025-10-14)
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 onl
Trial started· ClinicalTrials.gov
Efficacy of Metformin as an Adjunct to Standard Antidepressant Therapy in Treating Depression Among Obese Patients
Trial started· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in F
Primary completion· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
Primary completion· ClinicalTrials.gov
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer
Label revision· FDA
INDICATIONS & USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Label revision· FDA
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, accom
Label revision· FDA
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
Label revision· FDA
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, acco
Trial started· ClinicalTrials.gov
Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg
Primary completion· ClinicalTrials.gov
Diet and Exercise Plus Metformin to Treat Frailty in Obese Seniors
Primary completion· ClinicalTrials.gov
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With
Trial started· ClinicalTrials.gov
Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer
Trial started· ClinicalTrials.gov
Evaluating the Efficacy and Safety of Metformin in Vitiligo
Primary completion· ClinicalTrials.gov
A Study of BGM0504 in Overweight or Obese Participants
Trial registered· ClinicalTrials.gov
Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer
Trial registered· ClinicalTrials.gov
Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility
Primary completion· ClinicalTrials.gov
Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence
Label revision· FDA
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, accomp
FDA approval (supplemental)· FDA
Sponsor: HERITAGE. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: HERITAGE. Class: Labeling.
Label revision· FDA
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, accomp
Label revision· FDA
WARNING: LACTIC ACIDOSIS WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning . Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant brad
Trial registered· ClinicalTrials.gov
Metformin Hydrochloride and Empagliflozin Tablets in the Treatment of Type 2 Diabetes
Primary completion· ClinicalTrials.gov
Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility
FDA approval (supplemental)· FDA
Sponsor: ZYDUS LIFESCIENCES. Class: Manufacturing (CMC).
Trial started· ClinicalTrials.gov
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Trial started· ClinicalTrials.gov
Glycemic Regulation as Endometriosis Adjunct Treatment
Primary completion· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc.,
Trial started· ClinicalTrials.gov
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
FDA approval (supplemental)· FDA
Sponsor: MACLEODS PHARMS LTD. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: MACLEODS PHARMS LTD. Class: Labeling.
Trial started· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc.,
Primary completion· ClinicalTrials.gov
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
FDA approval· FDA
Sponsor: BIONPHARMA.
Results posted· ClinicalTrials.gov
Metformin Hydrochloride in Preventing Breast Cancer in Patients With Atypical Hyperplasia or In Situ Breast Cancer
Trial started· ClinicalTrials.gov
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients W
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
A Study of BGM0504 in Overweight or Obese Participants
Trial started· ClinicalTrials.gov
Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis
Trial registered· ClinicalTrials.gov
Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis
Primary completion· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hu
Trial started· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hu
Trial registered· ClinicalTrials.gov
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Label revision· FDA
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
Trial started· ClinicalTrials.gov
Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib
Trial started· ClinicalTrials.gov
A Study of BGM0504 in Overweight or Obese Participants
FDA approval (supplemental)· FDA
Sponsor: GRANULES. Class: Labeling.
Trial registered· ClinicalTrials.gov
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients W
Results posted· ClinicalTrials.gov
RCT Metformin for Reduction of Gestational Diabetes Mellitus Effects
Recall· FDA
Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC
FDA approval· FDA
Sponsor: ANNORA PHARMA.
Results posted· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitu
Trial registered· ClinicalTrials.gov
Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: BOEHRINGER INGELHEIM. Class: Efficacy.
Trial registered· ClinicalTrials.gov
SGLT2 Inhibitor Utilization Re-perfusion Therapy
Trial started· ClinicalTrials.gov
Metformin Hydrochloride Sustained-release Tablets (Ⅲ) in Patients With Type 2 Diabetes Mellitus Complicated With Coronary Heart Disease
Trial registered· ClinicalTrials.gov
Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis
Trial registered· ClinicalTrials.gov
Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes.
Primary completion· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hun
Primary completion· ClinicalTrials.gov
Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma
Recall· FDA
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.
Trial registered· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 12.5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc.,
Label revision· FDA
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, accom
Label revision· FDA
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Label revision· FDA
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, accom
Primary completion· ClinicalTrials.gov
Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radia
Trial started· ClinicalTrials.gov
Short-Term Metformin Use in Young, Healthy Adults: Impacts on Exercise Capacity
Trial registered· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/1000 mg Film-coated Tablets (Gedeon Richter Plc., Hu
Primary completion· ClinicalTrials.gov
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human
Trial started· ClinicalTrials.gov
Clinical Efficacy of 1% Metformin and Alendronate Gel in Adjunct to Fibrin in Chronic Periodontitis
Trial started· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hun
Label revision· FDA
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, accomp
Trial registered· ClinicalTrials.gov
Pharmacokinetics and Bioequivalence Study of Empagliflozin+Metformin Hydrochloride 5 mg/850 mg Film-coated Tablets (Gedeon Richter Plc., Hun
Trial registered· ClinicalTrials.gov
Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
2024
Primary completion· ClinicalTrials.gov
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
Primary completion· ClinicalTrials.gov
Canagliflozin and Myocardial Fibrosis
Primary completion· ClinicalTrials.gov
Metformin as RenoProtector of Progressive Kidney Disease
Trial started· ClinicalTrials.gov
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human
Primary completion· ClinicalTrials.gov
Effect of Metformin on Patients With Osteoarthritis
Recall· FDA
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayma
Primary completion· ClinicalTrials.gov
Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial
Primary completion· ClinicalTrials.gov
Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects
FDA approval (supplemental)· FDA
Sponsor: MSD SUB MERCK. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ASTRAZENECA AB. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: JANSSEN PHARMS. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: JANSSEN PHARMS. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: JANSSEN PHARMS. Class: Efficacy.
Trial started· ClinicalTrials.gov
Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy
Trial registered· ClinicalTrials.gov
Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human
FDA approval (supplemental)· FDA
Sponsor: SAPTALIS PHARMS. Class: Labeling.
Trial started· ClinicalTrials.gov
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Primary completion· ClinicalTrials.gov
A Study in Healthy Men to Test Whether BI 1815368 Influences the Amount of Metformin in the Body
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.