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Glimepiride

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 21, 2010

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 RDYPhase 1
Registered trials 89 across 21 sponsors since Aug 2002

Glimepiride target and mechanism

Molecular targetKCNJ11, ABCC8
Target classBlocker
ModalitySmall molecule

Also known as Amaryl

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

Glimepiride clinical trials

Glimepiride · 2 trials · 1 indication

Phase 1 2
NCT01052909Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting ConditionHealthy
COMPLETED44 Analytics
NCT01053689Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed ConditionHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Dr.Reddy's Laboratories Limited, Glimepiride Tablets 1 mg Under Fasting Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Dr.Reddys Laboratories Limited, Glimepiride 1 mg Tablets in Healthy Subjects Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fasting condition
4 months
Bioequivalence study of Dr. Reddy's Laboratories Limited, Glimepiride tablets 1 mg under Fed condition
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GlimepirideEXPERIMENTALGlimepiride tablets 1 mg of Dr. Reddy's Laboratories Limited
AmarylACTIVE_COMPARATORAmaryl 1 mg tablets of Aventis Pharmaceuticals Inc

Interventions

NameTypeDescription
GlimepirideDRUGGlimepiride tablets 1 mg
Glimepiride tablets 1 mgDRUG -
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Eligibility Criteria

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

Inclusion Criteria: * Male or non-child-bearing potential female,smoker and or non-smoker,18 years of age and older. * Capable of consent. * Non-child-bearing potential female subject: * Post-menopausal state:absence of menses for 12 months prior to drug. administration or hysterectomy with bilater...

Countries:Canada
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Frequently asked questions about Glimepiride

What is Glimepiride?

Glimepiride is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed, and its therapeutic area is classified as other.

What does Glimepiride target?

Glimepiride targets KCNJ11 and ABCC8. It is classified as a blocker of these targets. KCNJ11 and ABCC8 are the molecular targets named for this small molecule agent, which is being developed by Dr. Reddy's Laboratories Ltd.

Who makes Glimepiride?

Glimepiride is developed by Dr. Reddy's Laboratories Ltd, a company whose ticker symbol is RDY. Dr. Reddy's Laboratories Ltd is the sponsor behind the clinical studies of Glimepiride, including the bioequivalence trials conducted in healthy subjects.

What phase is Glimepiride in?

Glimepiride is in Phase 1 clinical development. It is an investigational drug and is not approved. Two Phase 1 trials have been completed, and no trials are currently active. Both completed studies were bioequivalence studies conducted in healthy adult subjects.

What clinical trials is Glimepiride in?

Glimepiride has been studied in two completed Phase 1 trials. NCT01053689 was a bioequivalence study of Glimepiride 1 mg tablets in healthy subjects under fed conditions, and NCT01052909 was a bioequivalence study of Glimepiride tablets 1 mg under fasting conditions. Each trial enrolled 44 participants in Canada.