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TDV

Takeda · Phase 3 active Biologic

TDV is a SGLT2 inhibitor Biologic drug developed by Takeda. It is currently in Phase 3 development for Type 2 diabetes. Also known as: TAK-003, DENVax, QDENGA.

TDV is a small molecule inhibitor of the sodium-glucose cotransporter 2 (SGLT2).

TDV is a small molecule inhibitor of the sodium-glucose cotransporter 2 (SGLT2). Used for Type 2 diabetes.

Likelihood of approval
61.3% 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).
  • Big-pharma sponsor +3.0pp
    Takeda is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
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 nameTDV
Also known asTAK-003, DENVax, QDENGA
SponsorTakeda
Drug classSGLT2 inhibitor
TargetSGLT2
ModalityBiologic
Therapeutic areaDiabetes
PhasePhase 3

Mechanism of action

By inhibiting SGLT2, TDV reduces glucose reabsorption in the kidneys, leading to increased glucose excretion in the urine and decreased glucose levels in the blood. This mechanism is associated with several potential benefits, including improved glycemic control and weight loss.

Approved indications

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about TDV

What is TDV?

TDV is a SGLT2 inhibitor drug developed by Takeda, indicated for Type 2 diabetes.

How does TDV work?

TDV is a small molecule inhibitor of the sodium-glucose cotransporter 2 (SGLT2).

What is TDV used for?

TDV is indicated for Type 2 diabetes.

Who makes TDV?

TDV is developed by Takeda (see full Takeda pipeline at /company/takeda).

Is TDV also known as anything else?

TDV is also known as TAK-003, DENVax, QDENGA.

What drug class is TDV in?

TDV belongs to the SGLT2 inhibitor class. See all SGLT2 inhibitor drugs at /class/sglt2-inhibitor.

What development phase is TDV in?

TDV is in Phase 3.

What are the side effects of TDV?

Common side effects of TDV include Increased risk of diabetic ketoacidosis.

What does TDV target?

TDV targets SGLT2 and is a SGLT2 inhibitor.

Related

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