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	37
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	447
Industry	90
NIH	73

Clinical Trials Update, Market Analysis, and Projection for Fluoxetine

Last updated: October 30, 2025

Introduction

Fluoxetine, commonly known by its brand name Prozac, is a selective serotonin reuptake inhibitor (SSRI) primarily prescribed for depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorder. Since its approval by the U.S. Food and Drug Administration (FDA) in 1987, fluoxetine has maintained its status as one of the most prescribed antidepressants worldwide. The evolving landscape of mental health treatment, ongoing clinical research, and regulatory developments continue to shape its market trajectory. This article provides an in-depth analysis of recent clinical trial updates, market dynamics, and future projections for fluoxetine, essential for stakeholders in the pharmaceutical industry, investors, and healthcare providers.

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Recent Clinical Trials Update

Ongoing and New Clinical Trials

While fluoxetine’s generic formulations dominate global markets, clinicians and researchers continue exploring novel indications, dosing strategies, and combinatorial regimens. ClinicalTrials.gov lists several ongoing studies:

• Treatment-resistant depression (TRD): Multiple trials are examining fluoxetine as an adjunct therapy for TRD, assessing its efficacy alongside newer agents, aiming to expand its therapeutic portfolio.
• Obsessive-compulsive disorder (OCD): Investigations are underway evaluating higher doses and extended treatment durations to optimize outcomes and reduce relapse rates.
• Pediatric Populations: Several studies are exploring safety and efficacy in children and adolescents with depression and anxiety disorders, aligning with regulatory interest in expanding indications to younger demographics.
• Neuroprotective and Cognitive Effects: Preliminary research is examining fluoxetine’s potential neuroplasticity-enhancing effects in neurodegenerative diseases, although these are in early phases.

Novel Formulations and Delivery Techniques

Advancements include the development of extended-release formulations aiming to improve patient adherence and minimize side effects. For example, a Phase II trial is assessing a once-weekly fluoxetine derivative designed for improved compliance, especially among chronic depression sufferers.

Safety and Pharmacovigilance

Recent post-market surveillance and meta-analyses continue to monitor adverse effects, notably serotonergic syndrome, sexual dysfunction, and emotional blunting. The FDA periodically updates safety warnings based on accumulating real-world data, influencing prescriber patterns.

Regulatory Landscape and Future Approvals

Although fluoxetine’s patent has long expired, regulatory agencies evaluate ongoing data for potential new indications or restricted uses, especially related to pediatric applications. Notably, the recent FDA rejection of some antidepressants for pediatric depression underscores the need for robust trial data to expand indications.

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Market Analysis

Global Market Overview

The global antidepressant market, valued at approximately USD 17.55 billion in 2022, is projected to reach USD 24.4 billion by 2030, expanding at a CAGR of 4.2% (2023–2030)[1]. Fluoxetine accounts for a significant share of this market, primarily due to its widespread use and availability as a generic medication.

Key Market Drivers

• Rising Prevalence of Depression and Anxiety: The World Health Organization estimates over 264 million people worldwide suffer from depression, fueling demand for SSRIs like fluoxetine[2].
• Increasing Awareness and Reducing Stigma: Greater awareness campaigns and destigmatization have led to higher treatment-seeking behavior.
• Generic Competition: Since patent expiration in the early 2000s, numerous generic manufacturers have expanded availability, driving down prices and increasing access.
• Expanding Indications: Emerging evidence supports fluoxetine’s potential beyond depression, including OCD, menopausal symptoms, and possibly neurodegenerative conditions, broadening its market scope.

Market Challenges

• Side Effect Profile: Concerns over sexual dysfunction and emotional blunting limit prescription in some cases.
• Competition from Newer Agents: SNRIs, atypical antidepressants, and novel agents like ketamine derivatives are capturing market share.
• Regulatory and Reimbursement Policies: Variability in approval and reimbursement policies across regions influences prescribing patterns.

Regional Market Dynamics

• North America: The largest market, driven by high healthcare spending, extensive mental health awareness, and established treatment guidelines.
• Europe: Growing acceptance, though regulatory delays and reimbursement issues vary between countries.
• Asia-Pacific: Rapid market growth, driven by increasing mental health awareness, urbanization, and pharmaceutical manufacturing capabilities.

Market Players

Leading generic manufacturers include Teva, Mylan, and Sandoz, with branded drugs by Eli Lilly and other entities focusing on adjunct therapies and formulations. Strategic partnerships, licensing agreements, and R&D investments shape competitive dynamics.

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Future Market Projections

Growth Drivers

• Expansion into New Therapeutic Areas: Ongoing trials into neuroplasticity-related indications, such as neurodegenerative diseases, could unlock new markets.
• Personalized Medicine: Pharmacogenomics research aims to tailor treatments, potentially increasing fluoxetine’s efficacy and acceptance.
• Digital Health Integration: Digitally-supported adherence programs and remote monitoring could improve treatment outcomes, making fluoxetine-based regimens more attractive.

Market Risks and Uncertainties

• Regulatory Changes: Stricter safety standards or restricted pediatric indications could impact market expansion.
• Patent and Market Entry Timelines: Despite generic dominance, patent litigations and regulatory delays can influence supply and pricing.
• Emergence of New Therapeutics: Rapid developments in neuromodulation and psychedelic-assisted therapies could diminish reliance on traditional SSRIs.

Projection Summary

The global fluoxetine market is expected to grow modestly at a CAGR of 3.5–4% through 2030, driven by increasing mental health disorders and expanding indications. While generic penetration limits premium pricing, incremental innovations in formulations and off-label uses present substantial growth opportunities.

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Conclusion

Fluoxetine remains a cornerstone in depression treatment, supported by a robust clinical trial pipeline exploring new indications and delivery methods. Market dynamics reflect its entrenched position, with growth propelled by rising mental health burdens and expanding treatment populations. However, competitive pressures from newer pharmacological agents and evolving regulatory landscapes imply that future growth will depend on innovation, safety profile enhancements, and strategic positioning within personalized medicine paradigms.

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Key Takeaways

• Clinical research advances continue to explore fluoxetine’s potential in resistant depression, OCD, pediatric use, and neuroregenerative applications.
• Market expansion is bolstered by global increases in depression and anxiety prevalence, with significant growth in Asia-Pacific.
• Generic manufacturing dominance ensures widespread accessibility but limits high-margin opportunities; innovation in formulations could offset this.
• Regulatory environments shape future indications; safety concerns and competing therapies necessitate ongoing vigilance.
• Long-term outlook suggests steady but moderate growth with potential for niche market development in emerging therapeutic areas.

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FAQs

1. Will fluoxetine retain its market dominance amid rising competition from newer antidepressants?
Yes. Its established efficacy, safety profile, and affordability as a generic maintain its market position. However, niche applications and formulation innovations could enhance its competitiveness.

2. Are there ongoing efforts to expand fluoxetine’s indications?
Yes. Clinical trials are investigating its role in neuroplasticity-related therapies and treatment-resistant conditions, potentially broadening approved uses.

3. How does safety concern influence fluoxetine’s market prospects?
While generally safe, side effects like sexual dysfunction impact prescribing in some populations. Continuous pharmacovigilance and formulation improvements aim to mitigate these concerns.

4. What regional factors influence the growth of fluoxetine markets?
Economic development, mental health awareness, healthcare infrastructure, regulatory policies, and pharmaceutical manufacturing capabilities are key regional determinants.

5. Could fluoxetine formulations evolve to meet future healthcare demands?
Absolutely. Extended-release and novel delivery mechanisms are under development to improve adherence, reduce side effects, and explore new therapeutic niches.

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References

[1] Grand View Research, "Antidepressant Market Size, Share & Trends Analysis," 2023.
[2] World Health Organization, "Depression Fact Sheet," 2022.