Steglatro

(Ertugliflozin)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Ertugliflozin is used to help lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove excess sugar through urine.[2] Steglatro is currently approved and in use across 7 indications[4].[1]

Steglatro is one of 189 small molecule programs targeting Ischemic Cardiomyopathy. It is currently in Approved.

Indications

Total Trials

Active Trials

188

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Ischemic CardiomyopathyActive, not recruiting

Mitral RegurgitationActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

FibrosisActive, not recruiting

Diabetes MellitusActive, not recruiting

Heart FailureApproved

Type 2 DiabetesApproved

Ischemic CardiomyopathyPhase 3

Active, not recruiting

Mitral RegurgitationPhase 3

Active, not recruiting

Type 2 Diabetes MellitusPhase 3

Active, not recruiting

FibrosisApproved

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

Heart FailureApproved

Approved

Type 2 DiabetesApproved

Approved

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Steglatro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

7 2

Byetta

AstraZeneca

Preclinical

55 3

NOVOLIN R

Novo Nordisk

Preclinical

5 4

Lovaza

AstraZeneca

Preclinical

1 5

SGLT-2 Inhibitor

SSheffield Teaching Hospitals NHS Foundation Trust

Preclinical

2 6

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

1 7

Henagliflozin

TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Preclinical

1 8

Antiplatelet Drug

FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Preclinical

1 9

Insulins

Eli Lilly

Preclinical

1 10

Sglt2i

UUniversity of Chicago

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

ApprovedNot yet recruiting

Type 2 Diabetes

NCT07621380

Clinical

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02226003·291 enrolled

A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01986855·468 enrolled

A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01958671·461 enrolled

Show 6 more trials

A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02033889·621 enrolled

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01999218·1,326 enrolled

Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02036515·464 enrolled

Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04029480·166 enrolled

Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01986881·8,246 enrolled

Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01948986·36 enrolled

Type 2 Diabetes7 trials

Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.

Withdrawn·—·Phase 4·NCT03640221

Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01054300·52 enrolled

A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate Glycemic Control on Metformin Monotherapy (MK-8835-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02630706·506 enrolled

Show 4 more trials

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01059825·375 enrolled

Study of Safety and Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes And Hypertension (MK-8835-042)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01096667·194 enrolled

Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.

Completed·AAmsterdam UMC, location VUmc·Phase 4·NCT04027530·40 enrolled

Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial

Not yet recruiting·SShanghai Zhongshan Hospital·Approved·NCT07621380·476 enrolled

Heart Failure3 trials

ERtugliflozin triAl in DIabetes With Preserved or Reduced ejeCtion FrAcTion mEchanistic Evaluation in Heart Failure

Completed·UUniversity Health Network, Toronto·Phase 2·NCT03416270·34 enrolled

Ertugliflozin in Chronic Heart Failure

Recruiting·YYale University·Phase 2·NCT04438213·60 enrolled

Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT04071626·9 enrolled

Overweight1 trial

A Multiple Dose Study Of Ertugliflozin (PF-04971729, MK-8835) In Otherwise Healthy Overweight And Obese Volunteers (MK-8835-037)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01018823·40 enrolled

ART1 trial

A Radiolabeled Mass Balance Study of [14C]-Ertugliflozin (PF04971729, MK-8835) In Healthy Male Participants (MK-8835-038)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01127308·6 enrolled

12 more indications

Ischemic Cardiomyopathy1 trial

Validation of ERTugliflozin for Inhibiting Cardiac Fibrosis Using Cardiac MRI and Laboratory Parameters in Korean Heart Failure Patients With Nonischemic Cardiomyopathy(VERTICAL)

Unknown status·YYonsei University·Phase 3·NCT04490681·52 enrolled

CAR1 trial

Ertugliflozin: Cardioprotective Effects on Epicardial Fat

Completed·SStanford University·Phase 1·NCT04167761·61 enrolled

Tics1 trial

Evaluation of Pharmacokinetics, Safety, And Tolerability Of Ertugliflozin (PF-04971729, MK-8835) In Japanese And Western Healthy Participants (MK-8835-041)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01223339·24 enrolled

Diabetes1 trial

Effect of Ertugliflozin on Cardiac Function in Diabetes

Completed·SSoo Lim·Phase 3·NCT03717194·102 enrolled

Adult1 trial

Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01114568·12 enrolled

Hepatic Impairment1 trial

Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02115347·16 enrolled

Fibrosis1 trial

Effect of Erugliflozin On Liver Fat, Liver Fibrosis and Glycemic Control in Type II DM Patients With NASH/NAFLD

Recruiting·GGetz Pharma·Phase 4·NCT05644717·164 enrolled

Oral1 trial

Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02099110·1,233 enrolled

Phase II1 trial

Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study

Terminated·MMedical University of Graz·Phase 3·NCT04600921·55 enrolled

Mitral regurgitation1 trial

Ertugliflozin for Functional Mitral Regurgitation

Completed·—·Phase 3·NCT04231331·128 enrolled

Fed1 trial

A Single Escalating Dose Study Of Ertugliflozin (PF-04971729, MK-8835) Under Fed and Fasted Conditons In Healthy Volunteers (MK-8835-036)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00989079·24 enrolled

Plasma Volume1 trial

ERTU-SODIUM: Study on the Effects of Ertugliflozin on Sodium Storage, Interstitial Volume, and Plasma Volume in HFrEF

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05152940·28 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 19, 2017

STEGLATRO

NDA NDA209803

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Ertugliflozin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Steglatro drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ertugliflozin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ertugliflozin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209803). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium/glucose Cotransporter 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Steglatro

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Type 2 Diabetes Mellitus9 trials

Type 2 Diabetes7 trials

Heart Failure3 trials

Overweight1 trial

ART1 trial

Ischemic Cardiomyopathy1 trial

CAR1 trial

Tics1 trial

Diabetes1 trial

Adult1 trial

Hepatic Impairment1 trial

Fibrosis1 trial

Oral1 trial

Phase II1 trial

Mitral regurgitation1 trial

Fed1 trial

Plasma Volume1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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