[Translation] A single-center, randomized, open-label, single-dose, two-dose, double-crossover, fasting and fed bioequivalence study of tenegliptin hydrobromide tablets in healthy participants

主要目的：以江苏天士力帝益药业有限公司提供的氢溴酸替格列汀片为受试制剂，按生物等效性研究的有关规定，以田辺三菱製薬株式会社生产的氢溴酸替格列汀片（商品名：TENELIA®）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，考察受试制剂与参比制剂在健康参与者体内的生物等效性。次要目的：观察评估空腹和餐后状态条件下口服受试制剂氢溴酸替格列汀片和氢溴酸替格列汀片（商品名：TENELIA®）在中国健康参与者中的安全性。

[Translation]

Main objective: To conduct a human bioequivalence study in the fasting/postprandial state using tenegliptin hydrobromide tablets provided by Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. as the test preparation and tenegliptin hydrobromide tablets (trade name: TENELIA®) produced by Tanabe Mitsubishi Pharmaceutical Co., Ltd. as the reference preparation in accordance with the relevant regulations of bioequivalence studies, and to investigate the bioequivalence of the test preparation and the reference preparation in healthy participants. Secondary objective: To observe and evaluate the safety of oral administration of the test formulations of tenegliptin hydrobromide tablets and tenegliptin hydrobromide tablets (trade name: TENELIA®) in Chinese healthy participants under fasting and fed conditions.

Start Date10 May 2025

Sponsor / Collaborator

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

CTR20250956

/ CompletedNot Applicable

氢溴酸替格列汀片（20mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of tenegliptin hydrobromide tablets (20 mg) in Chinese healthy subjects under fasting and fed conditions

主要研究目的：按有关生物等效性试验的规定，选择田辺三菱製薬株式会社为持证商的氢溴酸替格列汀片（商品名：Tenelia®，规格：20mg）为参比制剂，对吉林天衡英睿制药有限公司生产，安徽万邦医药科技股份有限公司持证的受试制剂氢溴酸替格列汀片（规格：20mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂氢溴酸替格列汀片（规格：20mg）和参比制剂氢溴酸替格列汀片（商品名：Tenelia®，规格：20mg）的安全性。

[Translation]

Main purpose of the study: According to the relevant provisions of bioequivalence tests, tenegliptin hydrobromide tablets (trade name: Tenelia®, specification: 20 mg) certified by Tanabe Mitsubishi Pharmaceutical Co., Ltd. were selected as the reference preparation, and the test preparation tenegliptin hydrobromide tablets (specification: 20 mg) produced by Jilin Tianheng Yingrui Pharmaceutical Co., Ltd. and certified by Anhui Wanbang Pharmaceutical Technology Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under fasting and fed administration conditions was evaluated. Secondary study objective: To observe the safety of oral administration of the test preparation of tenegliptin hydrobromide tablets (specification: 20 mg) and the reference preparation of tenegliptin hydrobromide tablets (trade name: Tenelia®, specification: 20 mg) in healthy volunteers.

Start Date19 Apr 2025

Sponsor / Collaborator

Anhui Wanbang Pharmaceutical Technology Co., Ltd.

CTR20251114

/ CompletedNot Applicable

氢溴酸替格列汀片在健康受试者中空腹和餐后状态下的单剂量、随机、开放、两周期、两序列、交叉设计的生物等效性试验

[Translation] A single-dose, randomized, open-label, two-period, two-sequence, crossover bioequivalence study of tenegliptin hydrobromide tablets in healthy subjects under fasting and fed conditions

主要研究目的：试验空腹和餐后状态下单次口服受试制剂氢溴酸替格列汀片（规格：20mg，浙江皓格药业有限公司生产）与参比制剂氢溴酸替格列汀片（Tenelia（泰里安），规格：20mg，Mitsubishi Tanabe Pharma Factory Ltd.,Yoshitomi Plant生产）在健康成年受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：空腹和餐后状态下，试验单次口服氢溴酸替格列汀片受试制剂和参比制剂（商品名Tenelia（泰里安））在健康成年受试者中的安全性。

[Translation]

Main study objectives: To test the pharmacokinetics of the test preparation of the test preparation of the hydrobromide tablets of tenegliptin (specification: 20mg, produced by Zhejiang Haoge Pharmaceutical Co., Ltd.) and the reference preparation of the hydrobromide tablets of tenegliptin (Tenelia, specification: 20mg, produced by Mitsubishi Tanabe Pharma Factory Ltd., Yoshitomi Plant) in healthy adult subjects in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary study objectives: To test the safety of the test preparation of the hydrobromide tablets of tenegliptin and the reference preparation (trade name Tenelia) in healthy adult subjects in the fasting and fed state.

Start Date18 Apr 2025

Sponsor / Collaborator

Hongguan Bio-pharma Co., Ltd.

100 Clinical Results associated with Teneligliptin Hydrobromide Hydrate

100 Translational Medicine associated with Teneligliptin Hydrobromide Hydrate

100 Patents (Medical) associated with Teneligliptin Hydrobromide Hydrate

350

Literatures (Medical) associated with Teneligliptin Hydrobromide Hydrate

01 Sep 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Teneligliptin, a DPP4 inhibitor protects dopaminergic neurons in PD models via inhibiting of oxidative stress and ferroptosis

Article

Author: Gu, Liqin ; Pi, Jiakai ; Wang, Wenya ; Liao, Zirou ; Huang, Linting

Parkinson's disease is a progressive neurodegenerative disorder with pathological hallmarks of loss of nigrostriatal dopaminergic neurons. Oxidative stress is one of the pivotal molecular pathways involved. Ferroptosis, a novel form of cell death, is closely associated with oxidative stress and presents a new potential therapeutic target for PD. Amounting reports showed that dipeptidyl peptidase-4 (DPP4) inhibitors, may hold potential for PD treatment. In this study, we found that Teneligliptin, a DPP4 inhibitor, when pretreated in SH-SY5Y cells, alleviated MPP⁺-induced cellular damage, including enhancing cell viability and modulating the Bax/Bcl-2 ratio. Furthermore, Teneligliptin not only inhibited the accumulation of reactive oxygen species (ROS), prevented the decline of mitochondrial membrane potential, decreased malondialdehyde (MDA) levels, restored glutathione (GSH) and superoxide dismutase (SOD) contents, but also lowered ferrous ion levels. At the same time, Teneligliptin restored antioxidant defenses by inhibiting DPP4 to enhance p62-mediated Keap1 degradation, thereby activating the Nrf2 signaling pathway. This upregulated downstream target including HO-1 and xCT, maintaining glutathione peroxidase 4 (GPX4) expression. Finally, Teneligliptin improved behavioral performance and protected dopaminergic neurons in MPTP-induced PD mouse. Taken together, our findings of Teneligliptin as a promising candidate for the treatment of PD warrant further study.

01 May 2025·ANALYTICAL BIOCHEMISTRY

In-vivo microwave-aided spectrofluorimetric characterization of teneligliptin-loaded solid dispersion adsorbate using quality by design approach

Article

Author: Prajapati, Pintu ; Shah, Shailesh ; Shah, Pranav ; Kansara, Yashwini ; Kalam, Mohd Abul ; Ardeshana, Princy ; Pulusu, Veera Shakar ; Haque, Anzarul

This study developed a microwave-aided spectrofluorimetric method for in-vivo characterizing teneligliptin-loaded solid dispersion adsorbate (TNG-SDA) using a quality by design approach. The microwave-aided chemical reaction was applied for derivatization of non-fluorescent teneligliptin with NBD-Cl (7-chloro-4-nitrobenzoxadiazole). TNG-SDA was prepared to enhance the solubility and bioavailability of teneligliptin, a BCS (Biopharmaceutical Classification System) class II drug. The method utilized environmentally friendly solvents and employed analytical quality by design principles for optimization. Critical method parameters were identified through failure mode impact analysis and optimized using response surface modelling. The fluorescence spectra of teneligliptin exhibited linearity across the concentration range of 50-250 ng/mL, with a correlation coefficient of 0.9978. The developed method was found to be accurate, precise, robust, specific and sensitive for estimation of teneligliptin. The method was applied to evaluate in vitro dissolution, pharmacokinetics, and pharmacodynamic of TNG-SDA compared to commercial formulations. Results showed significant improvements in teneligliptin solubility and bioavailability with the developed SDA. The microwave-aided derivatized fluorescent product was characterized by mass spectrometry. The method demonstrated environmental sustainability, robustness, sensitivity, cost-effectiveness, and user-friendliness when evaluated using white analytical chemistry approaches. It provided a sensitive and green alternative to existing hyphenated techniques for nanogram-level teneligliptin detection in pharmacokinetic studies.

01 Apr 2025·LUMINESCENCE

Failure Mode Effects Analysis and Design of Experiments to Sensitive and Sustainable Microwave‐Aided Spectrofluorophotometric Estimation of Teneligliptin and Method's Chlor‐Tox Scale and Blue Applicability Grade Index Assessment

Article

Author: Prajapati, Pintu ; Prajapati, Bhumika ; Shah, Shailesh ; Haque, Anzarul ; Ahmad, Sarfaraz

ABSTRACT:

Teneligliptin hydrobromide hydrate is efficiently controls blood sugar levels while minimizing the risk of hypoglycemia. Determination of teneligliptin in commercial formulations and biological‐fluids has been documented in literature using a plethora of chromatographic, spectrophotometric, and hyphenated methods and they required toxic organic solvents. But, there was no published spectrofluorophotometric technique for teneligliptin estimation. Hence, microwave‐aided spectrofluorophotometric method was developed to estimate teneligliptin with using green solvents and 7‐chloro‐4‐nitrobenzoxadiazole as a fluorescent probe. An integrated approach of white analytical chemistry and analytical quality by design was used to estimate teneligliptin in a robust, accurate, and precise manner. The failure mode effect analysis was used to identify the critical analytical method parameters and response variables. The design of experiments was used to carry forward the important analytical method parameters and response variables for response surface modeling. The proposed spectrofluorophotometric method was applied to evaluate commercially available formulations and investigate the pharmacokinetics of teneligliptin–loaded nano‐carriers that was developed in‐house. The fluorescent product that was derivatized using microwaves was separated and studied using mass spectrometry. After greenness and whiteness profile assessment, researchers discovered that the suggested approach to teneligliptin estimate was eco‐friendly, precise, robust, rapid, economical, and easy to apply.

News (Medical) associated with Teneligliptin Hydrobromide Hydrate

20 Oct 2022

·www.pharmaindustrial-india.com

Glenmark launches Teneligliptin + Dapagliflozin Fixed-Dose Combination for adults with Type 2 diabetes

Glenmark Pharmaceuticals became the first to launch Teneligliptin (20mg) + Dapagliflozin (5mg/10mg) fixed-dose combination (FDC) for the treatment of adult patients with type 2 diabetes, especially the ones with comorbidities. Marketed under the brand name Zita D; it contains Teneligliptin (20mg) + Dapagliflozin (5 mg/10 mg), and must be taken once daily under prescription to improve glycemic control & prevent complications in adult patients with type 2 diabetes, especially the ones with comorbidities. Alok Malik, EVP & Business Head, India Formulations, Glenmark Pharmaceuticals, said, “Diabetes is growing in India at an alarming rate, and eight out of every ten diabetic patients suffer from comorbidities. Glenmark being a leader in the diabetes segment in India is proud to bring Zita D, a well researched and affordable fixed-dose combination, which will significantly improve glycemic control in adult patients suffering from uncontrolled Type 2 diabetes, especially the ones with comorbidities.

Drug Approval

07 Sep 2017

·www.daiichisankyo.com

Japan’s First DPP-4 Inhibitor / SGLT2 Inhibitor Combination Drug Launch of CANALIA® Combination Tablets, a type 2 diabetes mellitus treatment agent

PDF (48KB)PDF For Immediate Release Mitsubishi Tanabe Pharma Corporation Daiichi Sankyo Co., Ltd. -Combination of selective DPP-4 inhibitor TENELIA® Tablets and SGLT2 inhibitor CANAGLU® Tablets- Osaka and Tokyo, Japan (September 7, 2017) - Mitsubishi Tanabe Pharma Corporation (hereafter Mitsubishi Tanabe Pharma; Head Office: Chuo-ku, Osaka; President & Representative Director, CEO: Masayuki Mitsuka) and Daiichi Sankyo Co., Ltd. (hereafter Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; Representative Director, President & COO: Sunao Manabe) announced today that both companies would launch CANALIA® Combination Tablets, a type 2 diabetes mellitus treatment agent that combines selective DPP-4 inhibitor TENELIA® Tablets (generic name: teneligliptin) and SGLT2 inhibitor CANAGLU® Tablets (generic name: canagliflozin), in Japan on September 7, 2017, following today’s inclusion of CANALIA® in the National Health Insurance drug price list. Approved for the first time in Japan, CANALIA® Combination Tablets is a combination drug that contains two ingredients, a DPP-4 inhibitor and a SGLT2 inhibitor.Both TENELIA® Tablets and CANAGLU® Tablets are type 2 diabetes mellitus treatment agents originally discovered by Mitsubishi Tanabe Pharma in Japan. CANALIA® Combination Tablets, a combination drug incorporating the above two constituents, is an orally-administered (once daily) agent that lowers blood-glucose levels based on two different mechanisms of action: inhibiting DPP-4 and thereby increasing insulin release according to blood glucose levels; and inhibiting SGLT2 and thereby promoting excretion of glucose into urine. Results of clinical trials conducted in Japanese Type 2 diabetes mellitus patients who have inadequate glycemic control to monotherapy with TENELIA® Tablets or CANAGLU® Tablets demonstrated efficacy, safety and good tolerability. Use of CANALIA® Combination Tablets by patients with type 2 diabetes mellitus whose blood glucose levels are stably controlled by concomitant treatment with TENELIA® Tablets and CANAGLU® Tablets will reduce the number of medicine and improve medication adherence. Use of CANALIA® Combination Tablets by type 2 diabetes mellitus patients who have inadequate glycemic control to monotherapy with TENELIA® Tablets or CANAGLU® Tablets is also expected to result in improved blood glucose control. Currently, marketing of TENELIA® Tabletsis conducted by Daiichi Sankyo, whereas marketing of CANAGLU® Tablets is carried out by Mitsubishi Tanabe Pharma. Marketing of CANALIA® Combination Tablets will be conducted by Daiichi Sankyo, and both companies will co-promote the product, as is the case with TENELIA® Tablets and CANAGLU® Tablets. Mitsubishi Tanabe Pharma and Daiichi Sankyo aim to contribute to the treatment of patients with diabetes by maximizing the product values of the above three agents in the diabetes treatment drug markets as well as by engaging in prompt and appropriate promotion activities through the alliance between both companies. For further information, please contact: Mitsubishi Tanabe Pharma Corporation Corporate Communications Department TEL: +81-6-6205-5211 Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1126

Drug Approval

03 Jul 2017

·www.daiichisankyo.com

Japan’s First DPP-4 Inhibitor / SGLT2 Inhibitor Combination Drug Application approved in Japan for CANALIA® Combination Tablets, a type 2 diabetes mellitus treatment agent

PDF (41KB)PDF For Immediate Release Mitsubishi Tanabe Pharma Corporation Daiichi Sankyo Co., Ltd. -Combination of selective DPP-4 inhibitor TENELIA® Tablets and SGLT2 inhibitor CANAGLU® Tablets- Osaka and Tokyo, Japan (July 3, 2017) - Mitsubishi Tanabe Pharma Corporation (hereafter Mitsubishi Tanabe Pharma; Head Office: Chuo-ku, Osaka; President & Representative Director, CEO: Masayuki Mitsuka) and Daiichi Sankyo Co., Ltd. (hereafter Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; Representative Director, President & COO: Sunao Manabe) announced today that on July 3, 2017, Mitsubishi Tanabe Pharma received manufacturing and sales approval for CANALIA® Combination Tablets, a type 2 diabetes mellitus treatment agent that combines selective DPP-4 inhibitor TENELIA® Tablets (generic name: teneligliptin) and SGLT2 inhibitor CANAGLU® Tablets (generic name: canagliflozin), from the Japanese Ministry of Health, Labour and Welfare. The approval is for an indication of type 2 diabetes mellitus. Approved for the first time in Japan, CANALIA® Combination Tablets is a combination drug that contains two ingredients, a DPP-4 inhibitor and a SGLT2 inhibitor.Both TENELIA® Tablets and CANAGLU® Tablets are type 2 diabetes mellitus treatment agents originally discovered by Mitsubishi Tanabe Pharma in Japan. CANALIA® Combination Tablets, a combination drug incorporating the above two constituents, is an orally-administered (once daily) agent that lowers blood-glucose levels based on two different mechanisms of action: inhibiting DPP-4 and thereby increasing insulin release according to blood glucose levels; and inhibiting SGLT2 and thereby promoting excretion of glucose into urine. Results of clinical trials conducted in Japanese T2DM patients who have inadequate glycemic control to TENELIA® Tablets or CANAGLU® Tablets demonstrated efficacy, safety and good tolerability. Use of CANALIA® Combination Tablets by patients with type 2 diabetes mellitus whose blood glucose levels are stably controlled by concomitant treatment with TENELIA® Tablets and CANAGLU® Tablets will enhance convenience and improve medication adherence. Use of CANALIA® Combination Tablets by type 2 diabetes mellitus patients who have inadequate glycemic control to monotherapy with TENELIA® Tablets or CANAGLU® Tablets is also expected to result in improved blood glucose control. Currently, marketing of TENELIA® Tabletsis conducted by Daiichi Sankyo, whereas marketing of CANAGLU® Tablets is carried out by Mitsubishi Tanabe Pharma. Marketing of CANALIA® Combination Tablets will be conducted by Daiichi Sankyo, and both companies will co-promote the product, as is the case with TENELIA® Tablets and CANAGLU® Tablets. Mitsubishi Tanabe Pharma and Daiichi Sankyo aim to contribute to the treatment of patients with diabetes by maximizing the product values of the above three agents in the diabetes treatment drug markets as well as by engaging in prompt and appropriate promotion activities through the alliance between both companies. For further information, please contact: Mitsubishi Tanabe Pharma Corporation Corporate Communications Department TEL: +81-6-6205-5211 Daiichi Sankyo Co., Ltd. Corporate Communications Department TEL: +81-3-6225-1126

Drug Approval

100 Deals associated with Teneligliptin Hydrobromide Hydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D09756	Teneligliptin Hydrobromide Hydrate	A10B	DB11950

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Japan	Mitsubishi Tanabe Pharma Corp.	29 Jun 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 1	-	Handok, Inc.	01 Jan 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


TOP RENAL (ADA2023)	Not Applicable	Type 2 diabetes mellitus with established diabetic nephropathy	377	Teneligliptin	vahbgicars(aidbofbsfg) = lwtgkrooci tiqfctyuhu (hezowjkltx )	Positive	20 Jun 2023
NCT02916706 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	254	Teneligliptin 20mg (Teneligliptin 20mg)	doavcykvbz(gruncylpmy) = ynqmrrgubu eukiirmjzo (bikkxcbgzz, 0.06) View more	-	28 Jan 2022
				Placebo (Placebo)	doavcykvbz(gruncylpmy) = roqchkmcbe eukiirmjzo (bikkxcbgzz, 0.06) View more
NCT02924064 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	247	Teneligliptin+Metformin (Teneligliptin 20mg + Metformin)	bvmdsqekwp(bnrenfwzol) = jwojabenqr lmupiyyjbp (ldilstycoc, 0.07) View more	-	28 Jan 2022
				Placebo+Metformin (Placebo + Metformin)	bvmdsqekwp(bnrenfwzol) = igonushdbi lmupiyyjbp (ldilstycoc, 0.07) View more
NCT03508323 (EASD2020)	Phase 4	Diabetes Mellitus, Type 2	65	Teneligliptin 20 mg	iroqirhywa(umemlxtosv) = xhujfhikhe czcszbnenx (pxyobjjvvo ) View more	Positive	24 Sep 2020
NCT02354222 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	154	Teneligliptin+Canagliflozin (Teneligliptin+Canagliflozin)	qkenwqicec(cnxanrbbai) = xzcrmqzcxe tkzlajgtov (vyhrinaorc, 0.08) View more	-	16 Aug 2018
				Placebo+Canagliflozin (Placebo+Canagliflozin)	qkenwqicec(cnxanrbbai) = jfeuoksfoh tkzlajgtov (vyhrinaorc, 0.08) View more
NCT02354222 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Canagliflozin+teneligliptin	efubolligr(lzbjbectkh): difference = -0.94, P-Value = <0.001	Positive	01 Feb 2018
				Canagliflozin+Placebo
NCT02081599 (Pubmed \| Expert Opin Pharmacother) Manual	Phase 4	Diabetes Mellitus, Type 2	148	teneligliptin	zrvqkjtifg(qlxvfylcil) = eljvagmdab grwgdpcoks (swbnceozuq, 0.11) View more	Positive	01 Sep 2017
				Placebo	jlekdkoarg(frxrklabue) = bohctpnzih nxosmcchsb (phztcjrpcb )
NCT02354235 (Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	138	canagliflozin as add-on therapy to teneligliptin	dzbrofxyfa(jorichgyyu): difference = -0.88, P-Value = < 0.001	Positive	01 Jun 2017
				Placebo+teneligliptin
NCT02081599 (CTgov)	Phase 4	Diabetes Mellitus, Type 2	148	Insulin+Teneligliptin (Placebo/Teneli (Teneligliptin) + Insulin)	vhkpeomoql(qqpbbfqpfd) = sigscrziok rwkhrmfnvg (mdsuixiprr, 0.08) View more	-	05 Jan 2017
				Insulin+Teneligliptin (Teneli (Teneligliptin) /Teneli + Insulin)	vhkpeomoql(qqpbbfqpfd) = whoftpismd rwkhrmfnvg (mdsuixiprr, 0.08) View more
CTRI/2014/01/004315 (EASD2016)	Phase 3	Diabetes Mellitus, Type 2	237	Teneligliptin 20 mg	ijpcoytjzs(ozzzgkxyqk): difference = 0.555 (95% CI, 0.176 - 0.934), P-Value = 0.0043 View more	Positive	13 Sep 2016
				Placebo

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