DPP-4 (Dipeptidyl Peptidase - 4) is an enzyme that is widely expressed throughout the body and abundantly expressed in endothelial cells. DPP-4 inhibition is a glucose-lowering treatment for type 2 diabetes. DPP-4 inhibitors act by inhibiting DPP-4 activity in peripheral plasma, which prevents the inactivation of incretin hormone glucagon-like peptide (GLP)-1 in the peripheral circulation, which in turn increases circulating intact GLP-1, resulting in stimulated insulin secretion and inhibited glucagon secretion, thereby increasing glucose utilization and reducing hepatic glucose production, which then through the reduction in postprandial and fasting glucose, reduces HbA1c. Merck (MSD), Takeda Pharmaceutical, Boehringer Ingelheim, Novartis, Eli Lilly, AstraZeneca, and Pfizer are some of the major market players in the diabetes segment with DPP-4 inhibitors in the market. Moreover, these companies also have DPP-4 inhibitors in their pipeline for more targeted therapy.
Key Market Developments:
- In Feb 2023, the European Commission approved Bristol-Myers Squibb and AstraZeneca’s Dapagliflozin for heart failure with reduced ejection fraction to cover patients across the full spectrum of left ventricular ejection fraction including heart failure with mildly reduced and preserved ejection fraction in European Union, Iceland, Norway, and Liechtenstein.
- In May 2023, the US FDA approved Bristol-Myers Squibb and AstraZeneca’s Dapagliflozin for chronic heart failure in the USA to reduce the risk of cardiovascular death and hospitalization for heart failure to a broader range of patients.
- In 2023, National Medical Products Administration, China (NMPA) granted approval for AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) to treat type-2 diabetes (T2D) in adult patients.
Approved Drug Molecules and Brand Names for DPP-4 Inhibitors:
- JANUVIA (Sitagliptin)
- GALVUS (Vildagliptin)
- TRADJENTA (Linagliptin)
- ONGLYZA (Saxagliptin)
- NESINA (Alogliptin)
- JANUMET (Metformin/Sitagliptin)
- Vildagliptin/Metformin
- JENTADUETO (Linagliptin/Metformin)
- SUGARNON (Evogliptin)
- TENELIA (Teneligliptin)
- GEMIGLO (gemigliptin)
- MARIZEV (Omarigliptin)
- QTERN (Dapagliflozin/Saxagliptin)
- ZAFATEK (Trelagliptin)
- LIOVEL (Alogliptin/Pioglitazone)
- GLYXAMBI (Empagliflozin/Linagliptin)
- KAZANO (Alogliptin/Metformin)
- SUINY (Anagliptin)
- ZEMIMET SR (Gemigliptin/Metformin extended-release)
- KOMBIGLYZE XR (Saxagliptin/Metformin XR)
- JANUMET XR (Sitagliptin/Metformin extended-release)
- CANALIA (Teneligliptin/Canagliflozin)
- SUJANU (Ipragliflozin/Sitagliptin)
- STEGLUJAN (Ertugliflozin/Sitagliptin)
- TENELIA M SR (Metformin/Teneligliptin)
Drugs under the Pipeline for DPP-4 Inhibitors:
- Retagliptin (SP2086)
- Dutogliptin (PHX1149T)
- Talabostat (BXCL701)
- Prusogliptin (DBPR108)
- Janacti (Sitagliptin/Pioglitazone)
- HSK7653
- Satyor (Gosogliptin)
- ZemiStatin (Gemigliptin/Rosuvastatin FDC)
- Trijardy XR (Empagliflozin/Linagliptin)
- ZemiSU (Gemigliptin/Glimepiride)
- Alogliptin Metformin extended release (CT-L01)
- Linagliptin/Pioglitazone
- Begedina (Begelomab)
- KRP-104
- Qternmet XR (Dapagliflozin/Saxagliptin)
- Dapagliflozin/Sitagliptin
- Fotagliptin (SAL067)
- IP10 C8
- TQ-F3083
- YS110
- ZYDPLA1
- Besigliptin (SHR117887)
- Dapagliflozin/Linagliptin (IN-C009)
- Dapagliflozin/Metformin/Sitagliptin (GMRx4)
- Dapagliflozin/Sitagliptin (DW6012)
- Enavogliflozin/Gemigliptin (DWJ1563)
- Glimepiride/Vildagliptin/Metformin (GVM)
- Melogliptin (GRC 8200)
- Metformin/Retagliptin (HRX0701)
- Sitagliptin /Atorvastatin (MK-0431E)
Clinical Activity and Developments of DPP-4 Inhibitors:
Currently, there are about 65 drug products, including 26 marketed products and more than 30 products in clinical trials in the DPP-4 inhibitors.
- In May 2022, AstraZeneca completed a phase-I trial in type 2 diabetes mellitus patients in Germany for Dapagliflozin/Sitagliptin fixed-dose combination.
- In Jun 2022, CSPC ZhongQi Pharmaceutical Technology completed a phase-III trial for type-2 diabetes mellitus in elderly patients in China for Prusogliptin (DBPR-108).
- In May 2023, BioXcel Therapeutics planned a phase-IIb trial for Tablostat (BXCL701) as monotherapy and in combination with Pembrolizumab for prostate cancer in the second half of 2023.
|
Molecule Name |
Number of Studies |
|
Retagliptin (SP2086) |
18 |
|
Dutogliptin (PHX1149T) |
15 |
|
Talabostat (BXCL701) |
14 |
|
Prusogliptin (DBPR108) |
12 |
|
Janacti (Sitagliptin/Pioglitazone) |
6 |
|
HSK7653 |
5 |
|
Satyor (Gosogliptin) |
4 |
|
ZemiStatin (Gemigliptin/Rosuvastatin FDC) |
4 |
|
Trijardy XR (Empagliflozin/Linagliptin) |
3 |
|
ZemiSU (Gemigliptin/Glimepiride) |
3 |
|
Alogliptin Metformin extended release (CT-L01) |
3 |
|
Linagliptin/Pioglitazone |
3 |
|
Begedina (Begelomab) |
2 |
|
KRP-104 |
2 |
|
Qternmet XR (Dapagliflozin/Saxagliptin) |
2 |
|
Dapagliflozin/Sitagliptin (SID1903) |
2 |
|
Fotagliptin (SAL067) |
2 |
|
IP10 C8 |
1 |
|
TQ-F3083 |
1 |
|
YS110 |
1 |
|
ZYDPLA1 |
1 |
|
Besigliptin (SHR117887) |
1 |
|
Dapagliflozin/Linagliptin (IN-C009) |
1 |
|
Dapagliflozin/Metformin/Sitagliptin (GMRx4) |
1 |
|
Dapagliflozin/Sitagliptin (DW6012) |
1 |
|
Enavogliflozin/Gemigliptin (DWJ1563) |
1 |
|
Glimepiride/Vildagliptin/Metformin (GVM) |
1 |
|
Melogliptin (GRC 8200) |
1 |
|
Metformin/Retagliptin (HRX0701) |
1 |
|
Sitagliptin /Atorvastatin (MK-0431E) |
1 |
Target Indication Analysis of DPP-4 Inhibitors
DPP-4 inhibitors are a class of prescription medicines that are used with diet and exercise to control high blood sugar in adults with type 2 diabetes mellitus. Additionally, DPP-4 inhibitors have also been marketed for cardiovascular disorders like chronic heart failure, renal failure, and type 1 diabetes mellitus. Bristol-Myers Squibb and AstraZeneca’s Dapagliflozin is in phase-III clinical trial for COVID-19 infections, heart failure, and myocardial infarction, and in phase-I trial for kidney disorders, liver cirrhosis, obesity, and pre-diabetic state. ADIENNE’s Begelomab is in phase-II/III for graft-versus-host disease, and phase-II for dermatomyositis
Regional Analysis of DPP-4 Inhibitors
DPP-4 Inhibitors Market
Merck (MSD)’s Januvia (Sitagliptin) and Janumet (Sitagliptin/ Metformin HCl) sales declined 34% to US$ 913 million in 2022 from US$ 1,393 million in 2021, primarily reflecting generic competition in certain international markets, particularly in Europe and the APAC region, and lower demand and net pricing in the USA. Novartis’s Glavus (Vildagliptin)’s sales declined to US$ 859 in the year 2022 due to lower sales in Japan, Europe, and Emerging growth markets. Boehringer Ingelheim’s Tradjenta (Linagliptin) will see all of its patent expiration by Mar 2031. Based on the World Health Organization’s 2020 data, overall, 243.3 million males and 229.0 million females worldwide had diabetes, where the age-standardized prevalence of diabetes was highest in Oceania, high-income North America, North Africa, the Middle East, and Central America.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
G JANUVIA (Sitagliptin), GALVUS (Vildagliptin), TRADJENTA (Linagliptin), ONGLYZA (Saxagliptin), NESINA (Alogliptin), JANUMET (Metformin/Sitagliptin) are the some of the approved drugs in the DPP-4 Inhibitors.
Total sale of Glavus (Vildagliptin) was US$ 859 in the year 2022.
Merck (MSD), Takeda Pharmaceutical, Boehringer Ingelheim, Novartis, Eli Lilly, AstraZeneca, and Pfizer are some of the major market players in the DPP-4 inhibitors market.
Type 2 diabetes mellitus is the major indication of DPP-4 inhibitors.
- Merck (MSD) (USA)
- Takeda Pharmaceutical (Japan)
- Boehringer Ingelheim (Germany)
- Novartis (Switzerlamd)
- Eli Lilly and Company (USA)
- AstraZeneca (UK)
- Mitsubishi Tanabe Pharma (USA)
- Pfizer (USA)
- Astellas Pharma (Japan)
- Handok Pharmaceuticals (South Korea)
- Jiangsu Hengrui Pharma (China)