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Famotidine

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 19, 2012

Famotidine development status

FDA approval on record May 28, 1998
Approval holderMerck
ApplicationNDA020752
Highest phase Phase 4 run by Bayer (NCT01928888)
Phase scored for RDYPhase 1
Registered trials 37 across 18 sponsors since Mar 2007

Famotidine target and mechanism

Molecular targetHRH2
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL902

Also known as Reddy Cheminor

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Famotidine clinical trials

Famotidine · 1 trial · 1 indication

Phase 1 1
NCT01511731Bioavailability Study of Famotidine Tablets 40 mg Under Fasting ConditionsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
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Study Endpoints

Primary Endpoints

Area Under Curve (AUC)
predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FamotidineEXPERIMENTALFamotidine tablets 40 mg of Dr. Reddy's
PepcidACTIVE_COMPARATORPepcid 40 mg Tablets of Merck \& Co.,

Interventions

NameTypeDescription
FamotidineDRUGFamotidine Tablets 40 mg
PepcidDRUG40mg tablets
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: * alcoholism or drug abuse within...

Countries:Canada
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Frequently asked questions about Famotidine

What is Famotidine?

Famotidine is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is in Phase 1 clinical development. The specific medical conditions it is being studied for have not been disclosed.

What does Famotidine target?

Famotidine targets HRH2, also known as the histamine H2 receptor. It acts as an antagonist at this receptor, meaning it blocks the action of histamine at HRH2. This mechanism is the basis for its pharmacological activity.

Who makes Famotidine?

Famotidine is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company whose shares trade under the ticker symbol RDY. The company is responsible for the clinical development of this asset.

What phase is Famotidine in?

Famotidine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program includes one completed trial.

What clinical trials is Famotidine in?

Famotidine has been studied in one completed Phase 1 trial, NCT01511731, titled Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions. The trial enrolled 30 healthy male volunteers in Canada and was active-controlled and randomized.