Clinical Trials

Numerous clinical trials evaluate the therapeutic and pharmacokinetic profiles, drug interactions, combination regimens, and glycemic management of teneligliptin in healthy volunteers and patients with type 2 diabetes mellitus across Phase 1 through Phase 4 and unspecified phases. Supported by academic and industrial sponsors, these studies consist predominantly of completed trials alongside investigations with unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07102719 COMPLETED
Healthy Volunteers
Handok Inc.
 2025-09-10 PHASE1
NCT06889350 COMPLETED
Healthy Volunteers
Handok Inc.
 2025-03-26 PHASE1
NCT06339788 COMPLETED
Healthy Volunteers
Handok Inc.
 2024-05-10 PHASE1
NCT05504239 COMPLETED
Type 2 Diabetes
Handok Inc.
 2022-09-27 PHASE3
NCT05504226 COMPLETED
Type 2 Diabetes
Handok Inc.
 2022-10-12 PHASE3
NCT04446026 COMPLETED
Type 2 Diabetes Mellitus
Yonsei University
 2020-07-08 PHASE4
NCT04431141 COMPLETED
Type 2 Diabetes Mellitus
Handok Inc.
 2020-09-15 PHASE1
NCT02449330 UNKNOWN
Diabetes Mellitus, Type 2
National Cerebral and Cardiovascular Center, Japan
 2015-06 PHASE4
NCT03508323 COMPLETED
Type 2 Diabetes Mellitus
Handok Inc.
 2018-04-03 PHASE4
NCT03769870 COMPLETED
Diabete Mellitus
Handok Inc.
 2019-01-11 PHASE1
NCT02924064 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2016-09 PHASE3
NCT03011177 COMPLETED
Type2 Diabetes Mellitus
Handok Inc.
 2017-01 PHASE4
NCT02916706 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2016-09 PHASE3
NCT02567994 COMPLETED
Type 2 Diabetes Mellitus
Handok Inc.
 2015-04 PHASE3
NCT03009513 COMPLETED
Diabetes Mellitus
Handok Inc.
 2017-01 PHASE1
NCT02512523 COMPLETED
Type 2 Diabetes Mellitus
Handok Inc.
 2015-08-27 PHASE4
NCT02354222 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2015-01 PHASE3
NCT02220907 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-08 PHASE3
NCT02081599 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2014-01 PHASE4
NCT02354235 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2015-01 PHASE3
NCT01301833 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2011-02 PHASE3
NCT02314637 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2009-08 PHASE3
NCT01026194 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2009-12 PHASE3
NCT00974090 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2009-09 PHASE3
NCT00998881 COMPLETED
Type 2 Diabetes Mellitus
Tanabe Pharma Corporation
 2009-09 PHASE3
NCT00628212 COMPLETED
Type 2 Diabetes
Tanabe Pharma Corporation
 2008-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-02-05)

Check the Teneligliptin hydrobromide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Teneligliptin hydrobromide acts as a potent competitive dipeptidyl peptidase-4 inhibitor, binding to the active site of dipeptidyl peptidase-4 to prevent the enzymatic cleavage and inactivation of incretin hormones such as glucagon-like peptide-1. This sustained elevation of active incretin levels enhances glucose-dependent insulin secretion from pancreatic beta cells while suppressing glucagon secretion, providing effective glycemic control in patients with type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.