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Ertugliflozin

Generic Name
Ertugliflozin
Brand Names
Segluromet, Steglatro, Steglujan
Drug Type
Small Molecule
Chemical Formula
C22H25ClO7
CAS Number
1210344-57-2
Unique Ingredient Identifier
6C282481IP

Overview

Ertugliflozin is a sodium-dependent glucose cotransporter-2 (SGLT2) inhibitor used to treat type II diabetes mellitus. It works to block glucose reabsorption from the glomerulus. Ertugliflozin was first approved by the FDA in December 2017. It was also approved by the European Commission in March 2018.

Indication

Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus (T2DM). It is also available in combination with either metformin or sitagliptin. Ertugliflozin is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2022/12/09
Phase 4
Recruiting
Getz Pharma
2021/12/10
Phase 4
Recruiting
2020/10/23
Phase 3
Terminated
Medical University of Graz
2020/07/29
Phase 3
UNKNOWN
2020/06/18
Phase 2
Recruiting
2020/01/18
Phase 3
Completed
2019/11/19
Early Phase 1
Completed
2019/08/28
Phase 4
Terminated
2019/07/23
Phase 3
Completed
2019/07/22
Phase 4
Completed
Amsterdam UMC, location VUmc

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
STEGLATRO
Merck Canada Inc
02475510
Tablet - Oral
5 MG
5/28/2018
SEGLUROMET
Merck Canada Inc
02476258
Tablet - Oral
7.5 MG
7/6/2018
STEGLUJAN
Merck Canada Inc
02475901
Tablet - Oral
5 MG
6/13/2018
SEGLUROMET
Merck Canada Inc
02476231
Tablet - Oral
7.5 MG
7/6/2018
STEGLATRO
Merck Canada Inc
02475529
Tablet - Oral
15 MG
5/28/2018
SEGLUROMET
Merck Canada Inc
02476215
Tablet - Oral
2.5 MG
7/6/2018
SEGLUROMET
Merck Canada Inc
02476223
Tablet - Oral
2.5 MG
7/6/2018
STEGLUJAN
Merck Canada Inc
02475928
Tablet - Oral
15 MG
6/13/2018

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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