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insulin secretagogue

Sanofi · Phase 3 active Small molecule Under review Quality 0/100

insulin secretagogue is a Insulin secretagogue Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Type 2 diabetes.

Stimulates the release of insulin from the pancreas.

Insulin secretagogues are a class of oral hypoglycemic agents that stimulate the insulin receptor, classified as an agonist. They are used to treat conditions such as type 2 diabetes, insulin resistance, and hyperinsulinemia, and are typically administered orally.

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
    Sanofi 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 nameinsulin secretagogue
SponsorSanofi
Drug classInsulin secretagogue
TargetATP-sensitive potassium channels
ModalitySmall molecule
Therapeutic areaDiabetes
PhasePhase 3

Mechanism of action

Insulin secretagogues work by binding to and activating the ATP-sensitive potassium channels in the pancreatic beta cells, leading to an increase in intracellular calcium and subsequent insulin release.

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 insulin secretagogue

What is insulin secretagogue?

insulin secretagogue is a Insulin secretagogue drug developed by Sanofi, indicated for Type 2 diabetes.

How does insulin secretagogue work?

Stimulates the release of insulin from the pancreas.

What is insulin secretagogue used for?

insulin secretagogue is indicated for Type 2 diabetes.

Who makes insulin secretagogue?

insulin secretagogue is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

What drug class is insulin secretagogue in?

insulin secretagogue belongs to the Insulin secretagogue class. See all Insulin secretagogue drugs at /class/insulin-secretagogue.

What development phase is insulin secretagogue in?

insulin secretagogue is in Phase 3.

What are the side effects of insulin secretagogue?

Common side effects of insulin secretagogue include Hypoglycemia.

What does insulin secretagogue target?

insulin secretagogue targets ATP-sensitive potassium channels and is a Insulin secretagogue.

Related

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