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Glisepin (GLISOXEPIDE)

Phase 2 active Small molecule Quality 28/100

Glisepin (generic name: GLISOXEPIDE) is a glisoxepide drug. It is currently in Phase 2 development for Diabetes mellitus type 2.

Glisoxepide works by blocking potassium channels in the pancreas, allowing more insulin to be released.

Glisoxepide is a small molecule drug in the glisoxepide class that targets the sulfonylurea receptor 1, Kir6.2. It is used to treat diabetes mellitus type 2, but its commercial status and regulatory approval are unknown. As a sulfonylurea receptor 1 antagonist, glisoxepide works by inhibiting the closure of potassium channels in pancreatic beta cells, leading to increased insulin secretion. This mechanism helps to lower blood glucose levels in patients with type 2 diabetes. Further information on its pharmacokinetics and safety profile is not available.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameGLISOXEPIDE
Drug classglisoxepide
TargetSulfonylurea receptor 1, Kir6.2
ModalitySmall molecule
Therapeutic areaMetabolic
PhasePhase 2

Mechanism of action

When you eat, your body breaks down the food into glucose, which is then released into your bloodstream. Normally, your pancreas releases insulin to help your cells absorb the glucose. Glisoxepide helps by keeping the potassium channels in your pancreas open, allowing more insulin to be released and helping your cells absorb the glucose more effectively.

Approved indications

Common side effects

No common side effects on file.

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 Glisepin

What is Glisepin?

Glisepin (GLISOXEPIDE) is a glisoxepide drug, indicated for Diabetes mellitus type 2.

How does Glisepin work?

Glisoxepide works by blocking potassium channels in the pancreas, allowing more insulin to be released.

What is Glisepin used for?

Glisepin is indicated for Diabetes mellitus type 2.

What is the generic name of Glisepin?

GLISOXEPIDE is the generic (nonproprietary) name of Glisepin.

What drug class is Glisepin in?

Glisepin belongs to the glisoxepide class. See all glisoxepide drugs at /class/glisoxepide.

What development phase is Glisepin in?

Glisepin is in Phase 2.

What does Glisepin target?

Glisepin targets Sulfonylurea receptor 1, Kir6.2 and is a glisoxepide.

Related

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