Drugs / Teneligliptin

Trials 28

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04431141 Sep → Nov 2020 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 1 NCT03769870 Jan → Feb 2019 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 1 NCT03009513 Jan → May 2017 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 1 NCT03787043 May → Jun 2014 — Handok Inc. Completed No outcome recorded
Phase 1 NCT03787017 Jan → Aug 2014 — Handok Inc. Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00971243 Aug 2009 → Apr 2011 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 2 NCT00628212 Jan → Dec 2008 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 314 trials · 2 met primary
Phase 3 NCT05504226 Oct 2022 → Nov 2023 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 3 NCT05504239 Sep 2022 → Apr 2024 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 3 NCT02924064 Sep 2016 → Sep 2018 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT02916706 Sep 2016 → Aug 2018 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT02567994 Apr 2015 → Oct 2017 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 3 NCT02354222 Jan 2015 → Feb 2016 type 2 diabetes mellitus Tanabe Pharma Corporation Completed Met primary
Phase 3 NCT01798238 Nov 2012 → May 2014 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 3 NCT01805830 May 2012 → May 2013 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 3 NCT01301833 Feb 2011 → Sep 2012 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 3 NCT01072331 Feb → Aug 2010 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded
Phase 47 trials · 2 met primary
Phase 4 NCT04446026 Jul → Dec 2020 type 2 diabetes mellitus Yonsei University Completed No outcome recorded
Phase 4 NCT03508323 Apr 2018 → Dec 2019 type 2 diabetes mellitus Handok Inc. Completed Met primary
Phase 4 NCT03011177 Jan 2017 → Sep 2018 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 4 NCT02512523 Aug 2015 → Sep 2016 type 2 diabetes mellitus Handok Inc. Completed No outcome recorded
Phase 4 NCT02449330 Jun 2015 → Jun 2020 type 2 diabetes mellitus National Cerebral and Cardiovascular Center, Japan Unknown No outcome recorded
Phase 4 NCT02312427 Jan 2015 → Mar 2016 congestive heart failure, diabetes mellitus Mitsui Memorial Hospital Completed No outcome recorded
Phase 4 NCT02081599 Jan 2014 → Jan 2016 type 2 diabetes mellitus Tanabe Pharma Corporation Completed Met primary
Comparator or background therapy7 trials
Phase 1 NCT07102719 Comparator Sep → Oct 2025 — Handok Inc. Completed No outcome recorded
Phase 1 NCT06889350 Comparator Mar → Apr 2025 — Handok Inc. Completed No outcome recorded
Phase 1 NCT06339788 Comparator May → Jun 2024 — Handok Inc. Completed No outcome recorded
Phase 3 NCT02354235 Background Jan 2015 → Jan 2016 type 2 diabetes mellitus Tanabe Pharma Corporation Completed Met primary
Phase 3 NCT02220907 Background Aug 2014 → Feb 2016 type 2 diabetes mellitus Tanabe Pharma Corporation Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2026-06-26 Tanabe Pharma Corporation Regulatory Regulatory Approval of CANALIA® Tablets, type 2 diabetes mellitus treatment agent in Thailand tanabe-pharma.com ↗
Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative Director, CEO: Akihisa Harada; hereinafter "Tanabe Pharma") announced today that on June 24th, 2026, Mitsubishi Tanabe Pharma (Thailand) Co., Ltd. (hereinafter “MTTH”) received Marketing Authorization for CANALIA® 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 Thailand.
2024-02-20 Tanabe Pharma Corporation Regulatory Application for Additional Dosage Form of CANALIA® Combination OD Tablets, Selective DPP-4 inhibitor/SGLT2 inhibitor Combination Drug tanabe-pharma.com ↗
Application for Additional Dosage Form of CANALIA® Combination OD Tablets, Selective DPP-4 inhibitor/SGLT2 inhibitor Combination Drug
2019-09-24 Tanabe Pharma Corporation Regulatory NMPA accepts our filing for TENELIA, a treatment agent for type 2 diabetes mellitus in China tanabe-pharma.com ↗
NMPA accepts our filing for TENELIA, a treatment agent for type 2 diabetes mellitus in China
2012-06-29 Tanabe Pharma Corporation Regulatory Marketing and Manufacturing Approval Received for TENELIA® 20mg Tablets A DPP-4 Inhibitor for Type 2 Diabetes Mellitus Originating from Japan tanabe-pharma.com ↗
Mitsubishi Tanabe Pharma Corporation (hereafter, Mitsubishi Tanabe; Head Office: Chuo-ku, Osaka; President & CEO: Michihiro Tsuchiya) and Daiichi Sankyo Co., Ltd., (hereafter, Daiichi Sankyo; Head Office: Chuo-ku, Tokyo; President & Representative Director: Joji Nakayama) announced today that Mitsubishi Tanabe has received approval to manufacture and market the selective DPP-4 inhibitor TENELIA ® 20mg tablets (generic name: Teneligliptin hydrobromide hydrate) in Japan.
2011-09-01 Tanabe Pharma Corporation Regulatory New Drug Application Filed in Japan for MP-513 a Type 2 Diabetes Treatment tanabe-pharma.com ↗
Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced that the Company filed to the Ministry of Health, Labor and Welfare an application for the manufacturing and marketing approval of MP-513 (generic name: teneligliptin), a type 2 diabetes treatment that has been developed in Japan.

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 36 sources stand behind the page.

FieldValueCited text
Known as teneligliptin “Effects of once-daily teneligliptin on 24-h blood glucose control and safety in Japanese patients with type 2 diabetes mellitus: a 4-week, randomized, double-blind,...” PMID 22776014 ↗ Jul 2012
31

“DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured.” NCT02312427 ↗

“The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes” NCT00974090 ↗

“Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin” NCT03014479 ↗

“Teneligliptin(MP-513) vs. Placebo in Patient With Metformin Monotherapy” NCT01805830 ↗

“Single does administration of Teneligliptin and Empagliflozin High” NCT06889350 ↗

“Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus” NCT01798238 ↗

“teneligliptin (20-40mg)” NCT02528019 ↗

NCT02512523 ↗

NCT00628212 ↗

NCT00998881 ↗

Show 21 more sources

Known as MP-513 “The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with Sulfonylurea (glimepiride) in Japanese patients...” NCT02314637 ↗
8

“The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone)” NCT01026194 ↗

“Teneligliptin(MP-513) vs. Placebo in Patient With Metformin Monotherapy” NCT01805830 ↗

“Teneligliptin(MP-513) Versus Placebo in Type 2 Diabetes Mellitus” NCT01798238 ↗

“MP-513 (Teneligliptin)” NCT02924064 ↗

“MP-513 (Teneligliptin)” NCT02916706 ↗

NCT00971243 ↗

NCT03787043 ↗

NCT03787017 ↗

Known as Teneli “Drug: Teneli (Teneligliptin)” NCT02081599 ↗
Known as Teneligliptin Hydrobromide “Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet” NCT05504239 ↗
1

“Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet” NCT05504226 ↗

Known as Teneligliptina ChEMBL registry synonym — accepted as the source's own label CHEMBL2147777 ↗
Known as Teneligliptine ChEMBL registry synonym — accepted as the source's own label CHEMBL2147777 ↗
Action Inhibit “teneligliptin 10 and 20 mg, a novel dipeptidyl peptidase-4 inhibitor” PMID 22776014 ↗ Jul 2012
1

“Dipeptidyl peptidase IV inhibitor” CHEMBL2147777 ↗

Modality Small molecule — CHEMBL2147777 ↗
Route Oral “Teneligliptin 10 mg, orally, once daily” NCT00628212 ↗
Target DPP4 “Dipeptidyl peptidase IV inhibitor” CHEMBL2147777 ↗