SGLT2 Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

sodium-glucose cotransporters 2 (SGLT2) is found in the apical membrane of the S1 and S2 segments of the proximal tubule. SGLT2 is a member of the sodium-glucose cotransporter family, which are sodium-dependent glucose transport proteins. SGLT2 is the major cotransporter involved in glucose in the kidney. SGLT2 is located in the early proximal tubule and is responsible for reabsorption of 80-90% of the glucose filtered by the kidney glomerulus. most of the remaining glucose absorption is by sodium/glucose cotransporter 1 (SGLT1) in more distal sections of the proximal tubule. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are the latest class of anti-hyperglycemic agents. Mechanism of action (MOA) of SGLT2 Inhibitor that works by blocking the sodium-glucose co-transporter 2 that facilitates glucose reabsorption in the kidney. As a result, reabsorption of glucose from the kidney is decreased, renal excretion of glucose is increased, and blood glucose levels are lowered. SGLT2 inhibitors are used in the treatment of diabetes mellitus, endocrine system diseases, metabolic diseases, kidney diseases, urologic diseases, hypertension, digestive system diseases, obesity, heart diseases, liver diseases, etc. Increased prevalence of diabetes mellitus and hypertension are the key drivers for the SGLT2 Inhibitor market. For instance, according to the World Health Organization 2023, about 422 million people worldwide have diabetes, the majority living in low-and middle-income countries. The launch of newer products by the market players could seek opportunities that influence extensive research and development in SGLT2 inhibitors. For instance, AstraZeneca’s Farxiga (Dapagliflozin) is used as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Novartis Licogliflozin (LIK066) for the indication of weight loss is under the various stages of clinical studies.

Key Market Developments:

• In April 2021, AstraZeneca’s Farxiga (Dapagliflozin) has received FDA approval for an additional indication of adults with chronic kidney disease who are at risk of disease progression.
• In August 2021, Boehringer Ingelheim and Eli Lilly’s Jardiance (Empagliflozin) received FDA approval for additional indication to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
• In May 2023, Lexicon Pharmaceuticals Inpefa (Sotagliflozin) received FDA approval for the treatment of heart failure.

Approved Drug Molecules and Brand Names for SGLT2 Inhibitor:

Jardiance (Empagliflozin)

Farxiga (Dapagliflozin)

Farxiga (Dapagliflozin) Invokana (Canagliflozin)

Inpefa (Sotagliflozin)

Suglat (Ipragliflozin)

Steglatro (Ertugliflozin)

Synjardy (Empagliflozin

Enblo (Enavogliflozin)

Qtern (Dapagliflozin

Ruiqin (Henagliflozin)

Xigduo (Dapagliflozin and Metformin Extended-Release)

Apleway (Tofogliflozin)

Vokanamet (Canagliflozin

Glyxambi (Empagliflozin

Lusefi (Luseogliflozin)

Steglujan (Ertugliflozin

Drugs under the Pipeline for SGLT2 Inhibitor:

Brenzavvy (Bexagliflozin)

Remozen (Remogliflozin Etabonate)

Licogliflozin (LIK066)

Rongliflozin (HEC44616)

DA-2811

Sujanu (Ipragliflozin

Trijardy XR

YG1699

MAR701

Qternmet Xr

Segluromet

Dapagliflozin/Sitagliptin (SID1903)

Henagliflozin/Metformin (HR20033)

Pioglitazone/Metformin/Dapagliflozin (BR3003)

ISIS 388626

Dapagliflozin/Linagliptin (IN-C009)

Dapagliflozin/Metformin (HCP1801)

Dapagliflozin/Olmesartan Medoxomil (ATB-101)

Dapagliflozin/Semaglutide (NN9917)

Dapagliflozin/Sitagliptin (DW6012)

Enavogliflozin/Metformin (DWJ1525)

Clinical Activity and Developments of SGLT2 Inhibitor:

Till June 2023, more than 40 companies having approximately 43 molecules targeting the number of cardiovascualr and endocrine diseases. For these molecules, more than 393 clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In December 2022, AstraZeneca’s has completed phase 1, randomized, open label, single and multiple doses, crossover study for evaluating the drug-drug interaction of Dapagliflozin (DWP16001) in combination with metformin in healthy male adults.
• In June 2023, Boehringer Ingelheim has completed phase 3, double blind, randomised, placebo controlled, parallel group study for evaluating the safety and efficacy of Empagliflozin and Linagliptin with a treatment safety extension period of 52 weeks in children and adolescents with Type-2 diabetes mellitus.