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Data updated: May 30, 2026

SAXAGLIPTIN (saxagliptin hydrochloride)

Metabolic Approved 2023-07-31
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2023-07-31
Routes
ORAL
Dosage Forms
TABLET

Companies

AMNEAL Viatris Aurobindo Pharma Sun Pharma PAR PHARM GLENMARK PHARMS LTD
Active Ingredient: SAXAGLIPTIN HYDROCHLORIDE

SAXAGLIPTIN Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2023 to 2023
Jul 2023 ORIGINAL
Update
FDA Letter

What SAXAGLIPTIN Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)

AMNEAL's other novel FDA approvals

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

ONGENTYS
2020
OPICAPONE
📋

Clinical Trial Registry

60 trials
Trial Sponsor ID Phase Status Title
NCT02285985 032 0086 Ph 4 completed Effects of Saxagliptin on Adipose Tissue Inflammation in Humans
NCT03199053 results posted D1680C00019 2015-005042-66 Ph 3 completed Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
NCT01527747 CV181-142 Ph 4 suspended Effects of DPP-4 Inhibition on Triglycerides
NCT02917031 MEASURE-HF results posted D1680C00016 Ph 4 completed Mechanistic Evaluation of Glucose-lowering Strategies in Patients With Heart Failure
NCT02597101 results posted RC-6059 1UH3TR001372-01 Ph 2 completed Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes
NCT02407899 NCRCMD LADA SAX 2015 Ph 4 completed Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes
NCT02419612 results posted CV181-365 Ph 3 completed A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
NCT02481479 SCARF 14-267 Ph 4 completed Saxagliptin and Cardiac Structure and Function
NCT01548651 results posted H-29171 Ph 4 terminated Effect of Saxagliptin Treatment on Myocardial Fat Content, and Monocyte Inflammation
NCT01922817 2012DM07 Ph 3 completed DPP4inhibitors in Type 1 Diabetes
NCT02471404 results posted D1689C00014 Ph 4 completed Efficacy and Safety of Dapagliflozin and Dapagliflozin Plus Saxagliptin in Combination With Metformin in Type 2 Diabetes Patients Compared With Sulphonylurea
NCT02024477 results posted CV181-305 Ph 4 completed Effect of Saxagliptin on EPCs as a Cellular Biomarker for Evaluating Endothelial Dysfunction in Early T2DM Patients
NCT02681094 results posted D1683C00005 Ph 3 completed A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes
NCT02280486 SPECIFY ISSSAXA0014 Ph 4 completed Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin
NCT02315495 ISSSAXA0015 Ph 3 completed Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
NCT02104739 results posted HSC-MS-13-0791 Ph 4 completed Effects of Antidiabetic Medications on the Postprandial State in Prediabetes
NCT02304081 95/8010-DASA-001 Ph 4 completed Saxagliptin in Combination With Dapagliflozin - Effects on Islet Cell Function
NCT02284893 results posted CV181-363 2014-001102-17 Ph 3 completed Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
NCT02089438 CODI24 200A Ph 4 completed DPP-4 Inhibition, Incretins and Islet Function
NCT02022007 BMS-AZPCOS results posted RP13-013 BMS CV181-354 Ph 3 completed Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis
NCT02182895 results posted 2014P001095 Ph 4 completed Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient
NCT01606007 results posted CV181-169 2012-000679-18 Ph 3 completed Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
NCT01434186 results posted CV181-147 2010-024568-16 Ph 3 completed 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
NCT01204775 results posted CV181-058 2010-020360-38 Ph 3 completed Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
NCT02243176 SMART results posted D1680L00018 Ph 4 completed 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy
NCT00857558 262-08-001 JapicCTI-090697 Ph 2 completed A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes
NCT02765204 ESR-15-11421 2015-005549-30 Ph 4 completed A Single-dose Cross-over Study to Assess Direct and Indirect Effects of Dapagliflozin on Pancreatic Alpha and Beta Cells in Patients With Type 2 Diabetes
NCT01782261 ADPP004 2011-006300-12 Ph 2 completed Incretin Effect on the Immunological Phenotype
NCT02920801 13040490434 Ph 4 completed Study About Effect of Saxagliptin on Circulating Endothelial Progenitor Cells and Endothelial Function in Newly Diagnosed Type 2 Diabetic Patients
NCT01646320 results posted MB102-129 2011-006324-20 Ph 3 completed Safety and Efficacy of Dapagliflozin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT02223065 results posted CV181-364 Ph 1 completed Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
NCT01619059 results posted CV181-168 2011-006323-37 Ph 3 completed Safety and Efficacy of Saxagliptin in Triple Therapy to Treat Subjects With Type 2 Diabetes
NCT01608724 SUNSHINE results posted D1680L00008 Ph 4 completed The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
NCT01525225 results posted CV181-153 Ph 1 terminated Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
NCT02060201 CV181-341 118,840 Ph 1 completed Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
NCT00683657 results posted CV181-066 Eudract-2008-000976-26 Ph 3 completed Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
NCT01765270 MAPSS results posted Pro00041744 Ph 4 terminated Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
NCT00918138 results posted CV181-085 Ph 3 completed 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
NCT01192139 results posted CV181-111 Ph 1 completed 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)
NCT00897390 results posted CV181-092 Ph 1 completed Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
NCT01192152 results posted CV181-112 Ph 1 completed Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
NCT01068743 results posted CV181-121 Ph 1 completed Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
NCT01662999 results posted CV181-191 Ph 1 completed Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants
NCT01365091 results posted CV181-162 Ph 1 completed Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
NCT00935467 CV181-091 Ph 1 completed Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
NCT01521312 ACCES P101105 Ph 2 completed ACute and Chronic Effects of Saxagliptin
NCT01107886 SAVOR- TIMI 53 results posted D1680C00003 EudraCT No 2009-017358-10 Ph 4 completed Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications
NCT01552018 SAXATH 2011/773b (REK) Ph 4 completed Saxagliptin and Atherosclerosis
NCT01305551 CV181-146 Ph 1 withdrawn 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
NCT01319357 ESENDI SAXA24011980GLIPTIN Ph 3 completed Effects of Saxagliptin on Endothelial Function

Showing 50 of 60 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.

SAXAGLIPTIN FDA Label Details

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Data Sources

FDA Approval: ANDA205941 → Trials: ClinicalTrials.gov →

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