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Fluoxetine

Phase 4FDA approved

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

Fluoxetine development status

FDA approval on record Mar 9, 1999
Approval holderLilly
ApplicationNDA020974
Highest phase Phase 4 run by Eli Lilly and Company (NCT00191399)
Phase scored for VTRSPhase 1
Registered trials 24 across 13 sponsors since May 2002

Fluoxetine target and mechanism

Molecular targetSLC6A4
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL41

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Fluoxetine clinical trials

Fluoxetine · 1 trial · 1 indication

Phase 1 1
NCT00649636Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mgHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg
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Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFluoxetine Capsules 40 mg
2ACTIVE_COMPARATORProzac Pulvules 40 mg

Interventions

NameTypeDescription
Fluoxetine Capsules 40 mgDRUG40mg, single dose fasting
Prozac Pulvules 40 mgDRUG40mg, 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 negative serum beta human chorionic gonadotropin (b-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the evening p...

Countries:United States
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Frequently asked questions about Fluoxetine

What is Fluoxetine?

Fluoxetine is a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is also known as Fluoxetine Capsules 40 mg. The specific therapeutic indication for this formulation is undisclosed, and the drug is in Phase 1 clinical development.

What does Fluoxetine target?

Fluoxetine targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is a membrane protein that regulates serotonin levels in the brain and other tissues.

Who makes Fluoxetine?

Fluoxetine is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the development of Fluoxetine Capsules 40 mg.

What phase is Fluoxetine in?

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

What clinical trials is Fluoxetine in?

Fluoxetine has been studied in one completed Phase 1 trial, NCT00649636, titled 'Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg.' This trial enrolled 32 healthy adult volunteers in the United States and was active-controlled and randomized.