Delving into the Latest Updates on Empagliflozin/Linagliptin/Metformin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

EmpaLinaMet XR, Empagliflozin/Linagliptin/Metformin, Empagliflozin/metformin/linagliptin

+ [5]

Target

DPP-4 x PRKAB1 x SGLT2

Mechanism

DPP-4 inhibitors(Dipeptidyl peptidase IV inhibitors), PRKAB1 activators(Protein kinase AMP-activated non-catalytic subunit beta 1 activators), SGLT2 inhibitors(Sodium/glucose cotransporter 2 inhibitors)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Boehringer Ingelheim GmbH

Active Organization

Boehringer Ingelheim Pharmaceuticals, Inc.

Inactive Organization

Boehringer Ingelheim GmbH

Drug Highest PhaseApproved

First Approval Date

US (27 Jan 2020),

Diabetes Mellitus, Type 2

Regulation-

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Structure/Sequence

Molecular FormulaC23H27ClO7

InChIKeyOBWASQILIWPZMG-QZMOQZSNSA-N

CAS Registry864070-44-0

View All Structures (3)

Bioequivalence of a Low Strength Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

The primary objective of this trial is to establish the bioequivalence of two empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC) tablets (Test, T) compared with the same doses of the individual components given in separate tablets (Reference, R) when administered together after a high-fat, high-calorie meal.
The assessment of safety and tolerability will be the secondary objective of this trial.

Start Date27 Aug 2018

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

NCT03259490

/ CompletedPhase 1

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

To establish the bioequivalence of one fixed dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single dose under fed conditions

Start Date31 Aug 2017

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

NCT02821910

/ CompletedPhase 1

Relative Bioavailability of Two FDC Tablet Strengths of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin and Metformin Extended Release Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin & metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

Start Date20 Jul 2016

Sponsor / Collaborator

Boehringer Ingelheim GmbH

[+1]

100 Clinical Results associated with Empagliflozin/Linagliptin/Metformin Hydrochloride

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100 Translational Medicine associated with Empagliflozin/Linagliptin/Metformin Hydrochloride

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100 Patents (Medical) associated with Empagliflozin/Linagliptin/Metformin Hydrochloride

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2

Literatures (Medical) associated with Empagliflozin/Linagliptin/Metformin Hydrochloride

15 Mar 2023·BMC chemistry

HPLC-DAD technique for the quantification of a recently approved anti-diabetic triple combination along with two toxic official impurities: Toxicity confirmation aided by molecular docking application.

Article

Author: Eissa, Maya S. ; Bahgat, Eman A. ; Hashem, Hisham ; Kamel, Ebraam B. ; Saleh, Hanaa

BACKGROUNDGliflozins and gliptins are two distinct groups of pharmacological drugs that reduce blood glucose levels in individuals with type II diabetes in various ways that may perform their functions harmoniously. Trijardy^® tablet, which contains empagliflozin, linagliptin, and metformin, was recently approved. The scientific database does not yet have a method that is sensitive enough to quantify the aforementioned medications in the presence of metformin official toxic impurities melamine and cyanoguanidine. Molecular docking modeling was utilized in this work to further prove the toxicity of melamine.METHODSThe five analytes listed before were quantified using RP-HPLC-diode array detector and a Zorbax^® C8 column (4.6 × 250 mm, 5 μm) with isocratic mobile phase composed of acetonitrile and 0.05 M potassium dihydrogen phosphate buffer, which had been treated by ?-phosphoric acid to restore a pH of 4.0 (90:10, v/v) at a flow rate of 1.2 mL/min and the eluted peaks were scanned at 250 nm.CONCLUSIONThe utilization of the simplest isocratic elution mode give the current technique a significant time-and cost-saving benefit. The current method can quantify the triple therapy agents in the presence of each other as well as with two official toxic impurities of metformin in one short analytical run.

01 Jun 2020·The Medical letter on drugs and therapeuticsQ4 · MEDICINE

In brief: Trijardy XR - a new 3-drug combination for Type 2 diabetes.

Q4 · MEDICINE

Article

100 Deals associated with Empagliflozin/Linagliptin/Metformin Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10BD	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	US	Boehringer Ingelheim Pharmaceuticals, Inc.	27 Jan 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03629054 (CTgov)	Phase 1	-	30	Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination) (Test Treatment (T))	tcrwjjdhgo(ffzxkuqevq) = aurujjsnvy yrhvjylsig (ksdyhxxszj, zhaudgmcnw - wevbsubmzm) View more	-	21 Feb 2020
				Linagliptin+Metformin HCl+Empagliflozin (Reference Treatment (R))	tcrwjjdhgo(ffzxkuqevq) = vjmujppfgo yrhvjylsig (ksdyhxxszj, bcpcfchkfl - mxwqwllurr) View more