Last reviewed 2026-05-21 · How we verify

Teneli / Teneli + pio

Tanabe Pharma Corporation · Phase 3 active Small molecule ✓ Verified May 2026

Teneli / Teneli + pio is a DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione Small molecule drug developed by Tanabe Pharma Corporation. It is currently in Phase 3 development for Type 2 diabetes mellitus (monotherapy and combination therapy).

Teneli is a DPP-4 inhibitor that increases incretin levels to enhance insulin secretion and reduce glucagon in response to meals, improving glycemic control in type 2 diabetes.

Teneligliptin (Teneli) is a medication used to treat Type 2 Diabetes Mellitus. It is studied in combination with pioglitazone (pio) for efficacy and safety in patients with Type 2 Diabetes, as part of a Phase III clinical trial.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Teneli / Teneli + pio
Sponsor	Tanabe Pharma Corporation
Drug class	DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione
Target	DPP-4 (dipeptidyl peptidase-4); pioglitazone targets PPAR-γ
Modality	Small molecule
Therapeutic area	Diabetes
Phase	Phase 3

Mechanism of action

Teneli inhibits dipeptidyl peptidase-4 (DPP-4), an enzyme that degrades incretin hormones (GLP-1 and GIP). By preventing incretin degradation, the drug prolongs their action, leading to glucose-dependent stimulation of insulin secretion and suppression of glucagon secretion. The combination formulation with pioglitazone (Teneli + pio) adds insulin sensitization through PPAR-γ activation.

Approved indications

Type 2 diabetes mellitus (monotherapy and combination therapy)

Common side effects

Hypoglycemia
Upper respiratory tract infection
Nasopharyngitis
Headache
Weight gain (with pioglitazone component)
Fluid retention (with pioglitazone component)

Key clinical trials

Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Teneli / Teneli + pio CI brief — competitive landscape report
Teneli / Teneli + pio updates RSS · CI watch RSS
Tanabe Pharma Corporation portfolio CI

Frequently asked questions about Teneli / Teneli + pio

What is Teneli / Teneli + pio?

Teneli / Teneli + pio is a DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione drug developed by Tanabe Pharma Corporation, indicated for Type 2 diabetes mellitus (monotherapy and combination therapy).

How does Teneli / Teneli + pio work?

Teneli is a DPP-4 inhibitor that increases incretin levels to enhance insulin secretion and reduce glucagon in response to meals, improving glycemic control in type 2 diabetes.

What is Teneli / Teneli + pio used for?

Teneli / Teneli + pio is indicated for Type 2 diabetes mellitus (monotherapy and combination therapy).

Who makes Teneli / Teneli + pio?

Teneli / Teneli + pio is developed by Tanabe Pharma Corporation (see full Tanabe Pharma Corporation pipeline at /company/tanabe-pharma-corporation).

What drug class is Teneli / Teneli + pio in?

Teneli / Teneli + pio belongs to the DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione class. See all DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione drugs at /class/dpp-4-inhibitor-combination-dpp-4-inhibitor-thiazolidinedione.

What development phase is Teneli / Teneli + pio in?

Teneli / Teneli + pio is in Phase 3.

What are the side effects of Teneli / Teneli + pio?

Common side effects of Teneli / Teneli + pio include Hypoglycemia, Upper respiratory tract infection, Nasopharyngitis, Headache, Weight gain (with pioglitazone component), Fluid retention (with pioglitazone component).

What does Teneli / Teneli + pio target?

Teneli / Teneli + pio targets DPP-4 (dipeptidyl peptidase-4); pioglitazone targets PPAR-γ and is a DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione.

Drug class: All DPP-4 inhibitor; combination: DPP-4 inhibitor + thiazolidinedione drugs
Target: All drugs targeting DPP-4 (dipeptidyl peptidase-4); pioglitazone targets PPAR-γ
Manufacturer: Tanabe Pharma Corporation — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes mellitus (monotherapy and combination therapy)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing