Last reviewed 2026-05-25 · How we verify

Teneli / Teneli + SU

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

Teneli / Teneli + SU is a DPP-4 inhibitor Small molecule drug developed by Tanabe Pharma Corporation. It is currently in Phase 3 development for Type 2 diabetes mellitus (in combination with sulfonylurea). Also known as: MP-513, Amaryl, glimepiride.

Teneli is a DPP-4 inhibitor that increases incretin levels to enhance insulin secretion and reduce glucagon in response to meals.

Teneligliptin (Teneli) is a medication used in combination with sulfonylurea (SU) to treat Type 2 Diabetes Mellitus. This combination was studied in a Phase III clinical trial (NCT00974090) to evaluate its efficacy and safety in Japanese patients with Type 2 Diabetes.

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 + SU
Also known as	MP-513, Amaryl, glimepiride
Sponsor	Tanabe Pharma Corporation
Drug class	DPP-4 inhibitor
Target	DPP-4 (Dipeptidyl peptidase-4)
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 activity, leading to glucose-dependent stimulation of insulin secretion and suppression of glucagon secretion. The 'SU' component likely refers to combination with a sulfonylurea agent for enhanced glycemic control.

Approved indications

Type 2 diabetes mellitus (in combination with sulfonylurea)

Common side effects

Hypoglycemia
Upper respiratory tract infection
Nasopharyngitis
Headache

Key clinical trials

Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea 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 + SU CI brief — competitive landscape report
Teneli / Teneli + SU updates RSS · CI watch RSS
Tanabe Pharma Corporation portfolio CI

Frequently asked questions about Teneli / Teneli + SU

What is Teneli / Teneli + SU?

Teneli / Teneli + SU is a DPP-4 inhibitor drug developed by Tanabe Pharma Corporation, indicated for Type 2 diabetes mellitus (in combination with sulfonylurea).

How does Teneli / Teneli + SU work?

Teneli is a DPP-4 inhibitor that increases incretin levels to enhance insulin secretion and reduce glucagon in response to meals.

What is Teneli / Teneli + SU used for?

Teneli / Teneli + SU is indicated for Type 2 diabetes mellitus (in combination with sulfonylurea).

Who makes Teneli / Teneli + SU?

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

Is Teneli / Teneli + SU also known as anything else?

Teneli / Teneli + SU is also known as MP-513, Amaryl, glimepiride.

What drug class is Teneli / Teneli + SU in?

Teneli / Teneli + SU belongs to the DPP-4 inhibitor class. See all DPP-4 inhibitor drugs at /class/dpp-4-inhibitor.

What development phase is Teneli / Teneli + SU in?

Teneli / Teneli + SU is in Phase 3.

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

Common side effects of Teneli / Teneli + SU include Hypoglycemia, Upper respiratory tract infection, Nasopharyngitis, Headache.

What does Teneli / Teneli + SU target?

Teneli / Teneli + SU targets DPP-4 (Dipeptidyl peptidase-4) and is a DPP-4 inhibitor.

Drug class: All DPP-4 inhibitor drugs
Target: All drugs targeting DPP-4 (Dipeptidyl peptidase-4)
Manufacturer: Tanabe Pharma Corporation — full pipeline
Therapeutic area: All drugs in Diabetes
Indication: Drugs for Type 2 diabetes mellitus (in combination with sulfonylurea)
Also known as: MP-513, Amaryl, glimepiride

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