CLINICAL TRIALS PROFILE FOR FLUOXETINE

505(b)(2) Clinical Trials for FLUOXETINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT03228732 ↗	The Effects of Fluoxetine and/or DHEA	Recruiting	University of Maryland	Early Phase 1	2017-12-19	(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.
OTC	NCT03228732 ↗	The Effects of Fluoxetine and/or DHEA	Recruiting	University of Maryland, Baltimore	Early Phase 1	2017-12-19	(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend against low blood sugar (hypoglycemia). (2) To learn how a hormone, dehydroepiandrosterone (DHEA), stimulates the participant's body's ability to defend itself from low blood sugar (hypoglycemia). DHEA is a hormone produced naturally in the human body. However, it can be manufactured and is sold as an over-the-counter dietary supplement. The dose the investigators are giving in this study is higher than the usual recommended dosage taken as a supplement for certain medical conditions. (3) To study combined effects of fluoxetine and DHEA during low blood glucose. In the present study, the investigators will measure the participant's body's responses to hypoglycemia when given fluoxetine or DHEA or fluoxetine and DHEA or a placebo (a pill with no fluoxetine or DHEA). Approximately 64 individuals with type 1 diabetes will take part in this study.
New Indication	NCT05283954 ↗	Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea	Not yet recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 2/Phase 3	2022-05-01	The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.

All Clinical Trials for FLUOXETINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000213 ↗	IV Cocaine Abuse: A Laboratory Model - 2	Completed	Columbia University	Phase 2	1990-04-01	The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
NCT00000213 ↗	IV Cocaine Abuse: A Laboratory Model - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1990-04-01	The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.
NCT00000213 ↗	IV Cocaine Abuse: A Laboratory Model - 2	Completed	New York State Psychiatric Institute	Phase 2	1990-04-01	The purpose of this study is to evaluate the effects of fluoxetine maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving.

Clinical Trial Conditions for FLUOXETINE

Condition Name

Condition Name for FLUOXETINE
Intervention	Trials
Depression	63
Major Depressive Disorder	48
Bipolar Disorder	10

Condition MeSH

Condition MeSH for FLUOXETINE
Intervention	Trials
Depression	149
Depressive Disorder	125
Depressive Disorder, Major	77

Clinical Trial Locations for FLUOXETINE

Trials by Country

Trials by Country for FLUOXETINE
Location	Trials
United States	586
Canada	37
China	24
France	19
Mexico	17

Trials by US State

Trials by US State for FLUOXETINE
Location	Trials
New York	48
California	38
Texas	30
Ohio	28
Massachusetts	25

Clinical Trial Progress for FLUOXETINE

Clinical Trial Phase

Clinical Trial Phase for FLUOXETINE
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for FLUOXETINE
Clinical Trial Phase	Trials
Completed	190
Recruiting	38
Unknown status	28

Clinical Trial Sponsors for FLUOXETINE

Sponsor Name

Sponsor Name for FLUOXETINE
Sponsor	Trials
National Institute of Mental Health (NIMH)	48
Eli Lilly and Company	17
New York State Psychiatric Institute	14

Sponsor Type

Sponsor Type for FLUOXETINE
Sponsor	Trials
Other	448
Industry	90
NIH	73

Fluoxetine Clinical Trials Update, Market Analysis and Projection

Last updated: May 2, 2026

What is fluoxetine and where does it sit in the pipeline?

Fluoxetine (brand names include Prozac and generics) is a long-established selective serotonin reuptake inhibitor (SSRI). It is not a late-stage “pipeline” drug in the way investors assess for proprietary biologics and platform assets. The practical market and clinical-trials picture for fluoxetine is dominated by (1) ongoing studies in defined populations, (2) comparative effectiveness research, (3) label refinements through post-approval studies, and (4) evolving formulations (especially pediatric, adherence, and switching strategies) rather than new molecular entity (NME) approvals.

What follows focuses on trial activity that uses fluoxetine as an active comparator or investigational arm, plus market structure that is characteristic of an off-patent small-molecule SSRI: price erosion, multi-generic competition, and “share defense” via guideline inclusion and stable demand.

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What clinical trials with fluoxetine are ongoing or recently completed?

How to read the fluoxetine trial landscape

For an off-patent SSRI, trial activity is typically concentrated in:

• Pediatric indications and dosing schedules (response, adherence, tolerability)
• Switching strategies (from other antidepressants/SSRI to fluoxetine)
• Augmentation and combination regimens (with psychotherapy or other drug classes in specific conditions)
• Narrow syndromes (e.g., OCD subgroups, anxiety phenotypes, perinatal depression frameworks)

Trial registration and reporting cadence

Fluoxetine trials tend to appear as:

• Randomized controlled trials comparing fluoxetine against placebo or active comparators
• Open-label or pragmatic trials assessing real-world outcomes across care settings
• Meta-study-linked trials that feed into guideline updates rather than seeking new approvals

Clinical outcome signals that recur across fluoxetine studies

Across trial designs, the endpoints most commonly used include:

• Change in symptom scales for depression and anxiety
• Time to response, response rate, and remission rate
• Discontinuation due to adverse events and tolerability metrics
• Treatment adherence and persistence (especially in pediatric and real-world studies)

Sources used for the fluoxetine evidence baseline and the SSRI clinical framing include the US prescribing information and major regulatory monographs for dosing and established indications ([1], [2]).

Note: This update emphasizes the clinical-trial model typical for established generics, because fluoxetine does not have an identifiable, proprietary “phase 3 catalyst” tied to a new patent estate.

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What does the market look like for fluoxetine?

Market structure

Fluoxetine is a mature, low-margin-to-mid-margin branded-to-generic transition story:

• Large generic penetration across geographies
• Multiple strengths and dosage forms supporting wide prescribing
• Physician familiarity and guideline positioning as a first-line SSRI option

Demand drivers

Key demand drivers that keep the volume base stable:

• Long-standing use in major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, bulimia nervosa, and other SSRI-responsive conditions (depending on jurisdiction and label) ([1], [2])
• Broad inclusion in antidepressant treatment pathways and switching algorithms
• Pediatric use in specific indications where fluoxetine is a guideline-referenced option

Supply and competition

The competitive structure is defined by:

• Price compression due to multi-generic supply
• Brand retention in some markets via legacy perception and payer contracting dynamics
• Market share shifts driven by formulary placement and PBM contracting rather than differentiation

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What are current label and safety parameters that affect use?

Key prescribing constraints that shape utilization

Fluoxetine prescribing decisions are influenced by established safety and monitoring requirements:

• Black box warning for suicidality in children, adolescents, and young adults during antidepressant treatment initiation ([1], [2])
• Drug interaction and serotonin syndrome risk with serotonergic co-medications
• Long half-life impacts washout and switching protocols (important for switching to or from other serotonergic agents)
• QT risk is not the primary fluoxetine limiter, but adverse-event profiles and comedication burden matter in practice

Regulatory references: US label safety language and dosage/administration sections ([1]) and comparable regulatory product information ([2]).

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How does fluoxetine pricing and contracting typically behave (projection framework)?

Base-case market mechanics for an off-patent SSRI

For a drug with mature competition, projections tend to follow:

• Volume stability or slow growth from prevalence dynamics and guideline consistency
• Net price erosion due to generic entry waves and competitive tendering
• Minor uplift from new formulation availability or expanded reimbursement

Scenario model (business-useful, not speculative)

A practical projection for fluoxetine in mature markets uses three levers:

1. Patient volume: growth tied to treated prevalence of depression and anxiety disorders
2. Realized net price: driven by generic contracting and PBM formularies
3. Share dynamics: influenced by switching patterns among SSRIs (citalopram/escitalopram/sertraline/fluoxetine)

Since fluoxetine has no active late-stage proprietary pipeline, the main “catalysts” are contracting and incremental clinical positioning.

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Market projection: what should investors and planners model?

Projection boundaries for fluoxetine

Because fluoxetine is an established generic medicine, projections are best modeled as a steady-state revenue stream with modest upside from volume and modest downside from price competition.

Projection directionally consistent with SSRI market dynamics:

• Near-term: continued price pressure, stable volume
• Mid-term: slight market expansion from prevalence and pediatric access, with persistent generic competition
• Long-term: renewals depend on formularies and payer economics rather than new approvals

Practical planning targets (how to translate into actions)

For R&D and BD:

• Treat fluoxetine as a benchmark for efficacy and tolerability in SSRI-comparative trials
• If pursuing combination or adherence tech, assume the competitive moat comes from the platform and program design, not from the fluoxetine molecule

For investment:

• Model revenues as contract-driven and low catalyst, with upside anchored in formulary wins and lifecycle management (presentations, dosing simplification, and payer preference).

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Where are the best opportunities for fluoxetine-linked development?

Commercial adjacencies rather than NME innovation

Given fluoxetine’s established molecule, the most actionable development opportunities typically land in:

• Real-world outcomes programs that generate payer evidence for antidepressant pathways
• Adherence and switching protocols that improve persistence and reduce discontinuation
• Subpopulation studies that refine dosing/tolerability in pediatrics and specific anxiety phenotypes

These initiatives tend to translate into formulary stability rather than new patent-protected revenue.

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Key Takeaways

• Fluoxetine is an established SSRI with ongoing evidence-generation patterns, but it does not present a proprietary late-stage clinical catalyst profile.
• Clinical activity is typically concentrated in defined populations, switching strategies, and pragmatic outcomes rather than new molecular approvals.
• The market is structurally generic, with revenue and share tied to payer contracting, formulary position, and persistence rather than differentiation.
• Near- to mid-term performance is best modeled with stable volume and ongoing net price pressure, moderated by pediatric access and guideline inclusion.
• The most durable business opportunities around fluoxetine are adjacent programs (adherence, real-world evidence, switching protocols) that support formulary uptake.

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FAQs

1) Is fluoxetine still being studied in new clinical trials?

Yes. Trial activity continues, mostly in comparative, population-specific, pragmatic, and switching frameworks typical for established generics.

2) Does fluoxetine have a patent-driven pipeline upside?

No. Revenue outlook depends on generic market dynamics and payer contracting rather than new patent-protected clinical catalysts.

3) What label elements most affect prescribing patterns?

The suicidality warning in younger patients, tolerability considerations, and known interaction and switching constraints are key drivers of clinician decision-making ([1], [2]).

4) What factors most influence fluoxetine market share?

Formulary placement, PBM contracting, tender dynamics, and switching preferences among SSRIs drive share shifts more than clinical differentiation.

5) Where is the best strategic use of fluoxetine in R&D?

As a comparator or standard-of-care anchor in SSRI-related research, and as a backbone for adherence or treatment-pathway programs that target persistence and discontinuation.

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References

[1] Eli Lilly and Company. Prozac (fluoxetine) prescribing information (US label).
[2] European Medicines Agency. Fluoxetine product information and regulatory assessment documents (summary product characteristics / EPAR documentation).