CLINICAL TRIALS PROFILE FOR PROZAC

505(b)(2) Clinical Trials for PROZAC

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.

All Clinical Trials for PROZAC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005015 ↗	Treatment of Depression in Youth With Bipolar Disorders	Terminated	National Institute of Mental Health (NIMH)	Phase 3	1969-12-31	THIS STUDY HAS BEEN DISCONTINUED. The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.
NCT00006204 ↗	Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 4	2000-03-01	This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.
NCT00006286 ↗	Treatment for Adolescents With Depression Study (TADS)	Completed	National Institute of Mental Health (NIMH)	Phase 3	1998-09-01	TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States. The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments? The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression. The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.
NCT00011765 ↗	Effect of Fluoxetine (Prozac) on Domestic Violence	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2001-02-22	This study will evaluate whether fluoxetine (Prozac), used together with traditional psychotherapy, can reduce aggression in people who are physically violent towards their spouses or significant others. Treatment for domestic violence has centered on behavioral therapies, such as anger management and self-control exercises. Recent studies have shown that fluoxetine-a drug commonly used to treat depression and panic disorder-can decrease acts of aggression. Men and women between the ages of 18 and 65 who have a history of inflicting physical aggression on a spouses or significant others in the past year (with at least one episode occurring not under the influence of alcohol) may be eligible for this study. Participants spouses or significant others will also be asked to participate. All potential participants will be screened with a medical and psychiatric evaluation and history, breath alcohol analysis, blood tests, urine drug screen and electrocardiogram. Those enrolled will undergo the following procedures: Perpetrator - Interview and questionnaires - Participants will be interviewed by a social worker about past and current mental health and use of alcohol and illicit drugs and will complete questionnaires assessing emotional state and personality, depression, anxiety, aggression and alcohol consumption. Some of the questionnaires will be repeated at monthly intervals. - Physical performance testing - Performance and speed will be measured in three separate training sessions that involve repeatedly pressing a button on a button box console, earning points worth money. - Dyadic interaction paradigm - Participants will interact with their spouse/significant other in a small room, first discussing a neutral topic, such as the day's events, and then a subject that has been a source of conflict. - Fluoxetine administration - Participants will be randomly assigned to receive either 10 mg. of fluoxetine or placebo (identical capsules with no active ingredients) once a day for 3 days, then twice a day, increasing up to four capsules a day if there are no serious side effects. Blood will be drawn once a month to measure drug levels. At the end of 3 months, participants taking placebo may remain in the study and receive fluoxetine. - Clinic visits - Participants are followed in the clinic weekly for the first month, then twice a month for the next 2 months for adjustment of number of pills, evaluation of aggressive behavior and alcohol consumption, and therapy for issues of self-esteem, anger management and communication skills. Couples therapy aimed at conflict resolution and improving communication skills will be offered. - Genetic tests (optional) - Blood will be drawn to determine if there is a relationship between genes involved in a chemical process (serotonin reuptake) that is influenced by fluoxetine and the participant's response to the drug. Spouse/Significant other: Spouses/significant others will complete several questionnaires once a month (total 4 times) to rate their partners' behavior while in the study. They will also participate in the dyadic interaction paradigm described above at the beginning and end of the study.

Clinical Trial Conditions for PROZAC

Condition Name

Condition Name for PROZAC
Intervention	Trials
Depression	23
Major Depressive Disorder	17
Healthy	7
Major Depression	6

Condition MeSH

Condition MeSH for PROZAC
Intervention	Trials
Depression	56
Depressive Disorder	47
Disease	30
Depressive Disorder, Major	28

Clinical Trial Locations for PROZAC

Trials by Country

Trials by Country for PROZAC
Location	Trials
United States	257
Canada	11
China	7
France	3
India	3

Trials by US State

Trials by US State for PROZAC
Location	Trials
New York	20
California	16
Pennsylvania	16
Texas	14
Ohio	11

Clinical Trial Progress for PROZAC

Clinical Trial Phase

Clinical Trial Phase for PROZAC
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	27
Phase 3	20

Clinical Trial Status

Clinical Trial Status for PROZAC
Clinical Trial Phase	Trials
Completed	80
Recruiting	11
Terminated	9

Clinical Trial Sponsors for PROZAC

Sponsor Name

Sponsor Name for PROZAC
Sponsor	Trials
National Institute of Mental Health (NIMH)	24
University of Pittsburgh	6
Eli Lilly and Company	6

Sponsor Type

Sponsor Type for PROZAC
Sponsor	Trials
Other	143
NIH	34
Industry	26

PROZAC (fluoxetine): Clinical Trials Update, Market Analysis, and Projections

Last updated: April 28, 2026

What is Prozac and what patents and exclusivity still matter?

PROZAC is the brand name for fluoxetine, an oral selective serotonin reuptake inhibitor (SSRI). Fluoxetine has long off-patent brand exclusivity in major markets, which shapes today’s clinical and commercial landscape: ongoing trials are dominated by new indications, new formulations, and line extensions rather than basic substance replacement.

Current commercial implication

• The global fluoxetine market is largely driven by generic supply, biosimilar-free small-molecule dynamics, and lifecycle extensions.
• Brand competitiveness depends on pricing, distribution contracts, and health-system formularies, not on patent-driven monopoly pricing.

Regulatory status note

• Fluoxetine is an approved active ingredient with extensive prescribing history across the US and EU. Search-level details on current patent estates vary by jurisdiction and assignee; a precise “still-in-force” map cannot be produced from the information provided.

What do current clinical trials focus on for fluoxetine?

Clinical development for fluoxetine is concentrated in areas that can shift endpoints within an established safety database:

• New indications or updated treatment positioning (e.g., depressive disorders subtypes, anxiety-spectrum disorders, adolescent populations with updated labeling strategies).
• Comparative efficacy against other antidepressants in defined cohorts.
• Adherence and tolerability work using optimized dosing strategies or formulation changes.
• Real-world evidence and pragmatic designs that support guideline placement and payer coverage.

Because fluoxetine is older and widely generic, the most common trial patterns in the last several years are:

• Smaller, indication-specific trials rather than large registrational phase programs.
• Endpoints tied to symptom scales and remission rates, with subgroup analyses that support guideline-aligned positioning.

Clinical trials update: what is the measurable signal investors track?

For an established molecule like fluoxetine, the investable “signal” is not the mere existence of trials. It is:

• Enrollment progress and top-line timing
• Site and country spread (proxy for recruiting difficulty and sponsor commitment)
• Endpoint selection aligned to labeling or guideline change pathways
• Comparator choice (standard-of-care vs. active antidepressants)
• Publication or results reporting cadence (conference vs. peer-reviewed)

A complete and accurate “trial-by-trial” update cannot be compiled without access to a current registry feed (e.g., ClinicalTrials.gov, EU CTR, ISRCTN) and sponsor-level status for each study.

Market analysis: how big is Prozac and where does demand come from?

PROZAC competes in the antidepressant SSRI class, but the product is constrained by:

• Generic substitution pressure in the US and EU
• Formulary management and step-therapy rules
• Price erosion across established oral antidepressants

Demand drivers

1. Depression and anxiety prevalence remain steady drivers for SSRI usage.
2. Clinical inertia: stable long-term prescribers often continue with established options.
3. Dosing familiarity and clinician comfort supports retention versus newer agents.
4. Therapeutic switching tends to be gradual because of tolerability and patient history.

Competitive set

• Other SSRIs (sertraline, citalopram, escitalopram, paroxetine) and newer antidepressant classes.
• In practice, formularies select a small set. Generic availability often determines that set more than pharmacology does.

Commercial implication for “brand Prozac”

• The brand’s value is mainly:
  • tender/formulary placement
  • patient adherence continuity
  • settled clinician prescribing patterns
• In most regions, long-run share is determined by net price, not differentiation.

Projection: how does Prozac perform through the next 3 to 5 years?

Without a jurisdiction-by-jurisdiction patent and exclusivity map, the only credible projections must be framed around market structure:

• Fluoxetine demand should stay structurally supported by depression treatment rates.
• Brand value should remain subdued by generic competition.
• Upside is most likely if:
  • payer policies increase brand reimbursement for specific patient populations
  • a formulation change improves adherence and generates formulary agreements
  • new indications expand the treatable segment

Base-case directional projection

• Overall fluoxetine volumes: stable to modestly declining in developed markets due to preference shifts toward newer generics and antidepressant switching patterns, but offset by population treatment demand.
• PROZAC brand share: gradually pressured by continued generic penetration and price competition.
• Revenue: tends to track price realization and formulary intensity, not molecule growth.

Scenario framework for business planning

A practical projection framework for Prozac-brand planning is:

• Conservative: continued price erosion, limited incremental uptake; brand share slowly declines.
• Base case: stable volumes with modest share drift; revenue flattening tied to contract pricing.
• Upside: formulary re-inclusion or targeted patient programs, limited competition from new entrants in certain channels, and any measurable benefit from adherence-oriented changes.

A numeric projection (CAGR, revenue ranges, and regional splits) cannot be generated without current topline market size inputs and an up-to-date patent and net pricing dataset.

What metrics matter most right now for Prozac exposure?

For investors and business planners, prioritize:

• Net price and rebate pressure (US and EU contracting)
• Share within key formularies (top 10 payer systems or equivalent)
• Generic manufacturer expansion and discounting intensity
• Any trial readouts tied to guideline updates
• Safety and discontinuation signals in post-marketing datasets (affects switching)

Key Takeaways

• PROZAC (fluoxetine) operates in a mature, heavily generic SSRIs market where clinical activity centers on new positioning rather than core patent-driven development.
• The investable commercial drivers are formulary access, net pricing, and prescribing inertia, not molecule novelty.
• A credible forward view is directional: volumes likely remain supported by baseline depression treatment needs, while brand economics face persistent generic price pressure.
• A trial “update” must be grounded in current registry status and results reporting, which is not available in the input.

FAQs

1. Is Prozac still protected by patents?
   Fluoxetine is a long-established active ingredient, and brand exclusivity has largely expired in major markets; current protections are often limited to specific jurisdictions, formulations, or process-related IP.

2. What types of clinical trials are most likely for fluoxetine today?
   Trials typically target new indication positioning, defined subpopulations, comparative efficacy, adherence/tolerability improvements, and guideline-relevant endpoints.

3. What drives Prozac revenue more: prescriptions or pricing?
   In a generic-dominated environment, revenue is usually more sensitive to net pricing, rebates, and formulary contracting than to marginal prescription growth.

4. Does fluoxetine growth depend on new drug approvals?
   Growth can come from incremental labeling shifts, guideline updates, and payer policies, but the baseline market remains anchored to existing depression treatment demand.

5. What is the most realistic projection style for Prozac?
   A scenario-based directional projection tied to market structure (generic penetration) and contracting (net price).

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. EPARs and information for centrally authorized medicines. https://www.ema.europa.eu/
[3] FDA. Drug approvals and labeling for fluoxetine (PROZAC). https://www.fda.gov/