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Glimepiride

Phase 4FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Glimepiride development status

FDA approval on record Nov 23, 2005
Approval holderSb Pharmco
ApplicationNDA021700
Highest phase Phase 4 run by Sanofi (NCT00633425)
Phase scored for VTRSPhase 1
Registered trials 88 across 21 sponsors since Aug 2002

Glimepiride target and mechanism

Molecular targetKCNJ11, ABCC8
Target classBlocker
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Glimepiride clinical trials

Glimepiride · 2 trials · 1 indication

Phase 1 2
NCT00648362Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mgHealthy
COMPLETED40 Analytics
NCT00650533Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mgHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALGlimepiride Tablets 1 mg
2ACTIVE_COMPARATORAmaryl® Tablets 1 mg

Interventions

NameTypeDescription
Glimepiride Tablets 1 mgDRUG1mg, single dose fasting
Amaryl® Tablets 1 mgDRUG1mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. a. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administrati...

Countries:United States
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Frequently asked questions about Glimepiride

What is Glimepiride?

Glimepiride is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as Glimepiride Tablets 1 mg. The listed development stage is Phase 1, and the clinical program includes two completed Phase 1 trials conducted in the United States.

What does Glimepiride target?

Glimepiride targets KCNJ11 and ABCC8. It is classified as a blocker of these targets. Both targets are part of the ATP-sensitive potassium channel complex, and the drug acts through this molecular target class according to the available drug profile information.

Who makes Glimepiride?

Glimepiride is developed by Viatris Inc., which trades under the ticker VTRS. The company is listed as the developer of the Glimepiride Tablets 1 mg program, which includes two completed Phase 1 clinical trials.

What phase is Glimepiride in?

Glimepiride is in Phase 1 development. Both listed trials are Phase 1 studies, and both have completed status. The program has no active trials at this time, with a total of two completed trials and 80 enrolled participants across the program.

What clinical trials is Glimepiride in?

Glimepiride has been studied in two completed Phase 1 trials: NCT00650533, a food study of Glimepiride Tablets 1 mg versus Amaryl Tablets 1 mg, and NCT00648362, a fasting study of the same comparison. Both enrolled 40 healthy volunteers in the United States.