CLINICAL TRIALS PROFILE FOR FLUOXETINE HYDROCHLORIDE

505(b)(2) Clinical Trials for FLUOXETINE HYDROCHLORIDE

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.
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	National Department of Health, Papua New Guinea	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.
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	Oriol Mitja	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 HYDROCHLORIDE

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.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	University of Florida	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000379 ↗	Fluoxetine vs EMDR to Treat Post-Traumatic Stress Disorder (PTSD)	Completed	National Institute of Mental Health (NIMH)	Phase 3	1999-01-01	The purpose of this study is to compare two treatments for post-traumatic stress disorder (PTSD): fluoxetine (an antidepressant) and Eye Movement Desensitization and Reprocessing (EMDR, a psychological treatment in which the patient is led through the memory of a traumatic experience in order to heal him/herself). There are a variety of therapies used to treat PTSD, but the effectiveness of medication alone vs an exposure treatment, such as EMDR, has not been tested. Patients will be assigned randomly (like tossing a coin) to one of three groups for 8 weeks of treatment. Group 1 will receive fluoxetine; Group 2 will receive EMDR; and Group 3 will receive inactive placebo. Patients will then stop treatment and have evaluations, including psychological tests, at the time treatment is stopped, 8 weeks later, and at 6 months. An individual may be eligible for this study if he/she: Has PTSD and is 18 to 65 years old.

Clinical Trial Conditions for FLUOXETINE HYDROCHLORIDE

Condition Name

Condition Name for FLUOXETINE HYDROCHLORIDE
Intervention	Trials
Depression	63
Major Depressive Disorder	48
Bipolar Disorder	10
Depressive Disorder	9

Condition MeSH

Condition MeSH for FLUOXETINE HYDROCHLORIDE
Intervention	Trials
Depression	149
Depressive Disorder	125
Depressive Disorder, Major	77
Disease	63

Clinical Trial Locations for FLUOXETINE HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for FLUOXETINE HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for FLUOXETINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for FLUOXETINE HYDROCHLORIDE
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 HYDROCHLORIDE
Sponsor	Trials
Other	448
Industry	90
NIH	73

Fluoxetine Hydrochloride Clinical Trials Update, Market Analysis, and Long-Term Projection (US and Key Ex-US Markets)

Last updated: May 21, 2026

Fluoxetine hydrochloride (Prozac and generics) is an off-patent, widely manufactured antidepressant with no material schedule for primary-compound exclusivity. Market growth is driven mainly by substitution cycles, formulary positioning, and demand persistence in major indications, not by new regulatory exclusivity. Clinical development activity centers on new formulations (including delayed-release and pediatric/indication-specific work), line extensions, and combination strategies rather than novel fluoxetine mechanisms.

What clinical trials are active or recently completed for fluoxetine hydrochloride?

Featured snippet: Current clinical activity is dominated by formulation and access/indication-focused studies rather than first-in-class fluoxetine mechanism trials. Fluoxetine’s molecule is long-established; late-stage trials that move the standard of care typically involve (1) pediatric formulations, (2) modified-release concepts, (3) adherence or dosing convenience, and (4) label maintenance work tied to specific populations (often children/adolescents for depression and related psychiatric indications).

Which phases dominate fluoxetine hydrochloride trial activity?

• Phase 2/3: Often pediatric label work, symptom domain refinements, or comparative efficacy versus other antidepressants in defined subpopulations.
• Phase 1: Bioequivalence and PK studies for generic or formulation variants (including capsule/tablet changes, dose strengths, and modified-release formats).
• “Real-world”/post-authorization studies: Persistence, adherence, switching patterns, and safety monitoring.

How do trial endpoints typically map to current regulatory expectations?

• Efficacy: Change in depression rating scales (commonly variants of MADRS or similar instruments), response and remission rates.
• Safety/tolerability: Suicidality screening in pediatric populations, activation-related adverse events, GI tolerability, discontinuation rates.
• PK/BE: Cmax and AUC bioequivalence windows; food-effect and steady-state confirmation for modified-release or new excipient systems.

What are the most common trial geographies for fluoxetine hydrochloride work?

• US and EU are typical for regulatory-facing bioequivalence and labeling work.
• India, Brazil, and Eastern Europe are frequent for generic registration and local BE studies.
• Pediatric-focused trials appear in countries with mature pediatric research networks.

What clinical trials are most relevant for near-term commercial impact?

Near-term impact comes from:

• New formulation approvals that change payer preference (for example, easier dosing, tolerability advantages, or modified-release variants).
• Pediatric or dosing-frequency label improvements that can support updated prescribing patterns and pharmacy benefit designs.
• Combination trials that align with payer-supported pathways for comorbid depression/anxiety categories (notably anxiety spectrum, though specific programs vary by sponsor).

What patents protect fluoxetine hydrochloride, and when do they expire?

Featured snippet: Fluoxetine hydrochloride itself is off patent in most jurisdictions; the competitive barrier is primarily formulation/variant IP, not the active ingredient.

What is the patent reality for the API versus product formats?

• Active ingredient protection: Expired long ago in major markets.
• Secondary IP: Any remaining protection is generally tied to:
  • specific formulations (excipients, particle size ranges, solid-state forms)
  • modified-release technologies
  • dose presentations and manufacturing process elements
  • sometimes method-of-use claims if any legacy patents exist for specific population subgroups or protocols

Why does IP matter less for clinical development but more for specific SKUs?

Because fluoxetine is broadly generic, clinical development often targets defensible SKU differentiation. Any company that can win exclusivity on a formulation variant can capture short-term premium pricing. Absent that, clinical trials primarily support regulatory approvals rather than differentiated therapeutic positioning.

What is the market size for fluoxetine hydrochloride today and what drives demand?

Featured snippet: Demand is anchored by chronic antidepressant use and long-standing formulary penetration; growth is primarily volume growth and substitution, not new patient creation.

Key demand drivers

• Chronic use in major depressive disorder and anxiety spectrum indications where fluoxetine is commonly prescribed.
• Pediatric depression history in many markets keeps a baseline demand level.
• Switching cycles: When payers rebalance preferred antidepressants, fluoxetine maintains a stable share because of safety familiarity and broad prescriber comfort.
• Generic availability: Keeps price elasticity high, with utilization tied to lowest-cost formularies.

Commercial structure

• US: Multiple ANDA filers, extensive generic competition, low price dispersion by strength/form.
• Europe: Local generic lineups with strong price controls and tendering dynamics.
• Emerging markets: Price remains constrained; volumes depend on access policies and procurement cycles.

Which companies dominate fluoxetine hydrochloride supply and what is the competitive landscape?

Featured snippet: The market is structurally competitive with a large generic supplier base; competitive advantage comes from manufacturing capacity reliability, tender execution, and portfolio depth.

How competition typically affects price and availability

• Price pressure: Multiple ANDAs for the same strengths and dosage forms compress margins.
• Formulary leverage: Payers prefer lowest WAC or contracted prices, rewarding suppliers with stable supply and frequent tender wins.
• Supply chain risk: Batch availability and regulatory inspection outcomes can transiently shift market share.

Where brand-like dynamics can still appear

• Newly differentiated formulations (if any) and direct-to-generic marketing for specific strengths can recreate short-term share gains.
• Switching from other SSRIs can produce episodic share movement, but the market tends to normalize after tender cycles.

How do fluoxetine hydrochloride clinical trial results translate into market outcomes?

Featured snippet: Clinical differentiation for fluoxetine is usually limited; trial outcomes matter most when they support regulatory acceptance for a specific formulation or population.

Translation pathways

1. Regulatory label expansions or clarifications
   • Can shift prescribing in pediatric subsets and specific comorbidity profiles.
2. Formulation approvals
   • Enable pharmacy benefit formulary updates and can improve tolerability-based adherence, which supports chronic use.
3. Comparative effectiveness
   • Often influences guideline adherence in some settings, but with generics the ultimate lever is payer placement.

When does fluoxetine hydrochloride lose exclusivity, and what does that mean for generic entry risk?

Featured snippet: Exclusivity is largely gone; the primary remaining “entry risk” is not patent-driven but regulatory quality and manufacturing capacity.

Generic launch risk profile

• With fluoxetine off exclusivity, the typical risk drivers are:
  • ANDA approval timing and required BE/CMC completeness
  • site inspection outcomes
  • supply continuity during launch ramp
  • payer contracting speed

What would still block or delay entry

• Formulation-specific IP or trade-dress-like market restrictions on certain presentations, if any still apply.
• Site-specific regulatory issues that suspend product availability.

What regulatory status does fluoxetine hydrochloride have in the US and key foreign markets?

Featured snippet: Fluoxetine hydrochloride is fully marketed as a generic and remains widely approved in multiple dosage forms and strengths.

US regulatory pathway context

• Most market supply is under ANDA.
• Any new “breakthrough-like” regulatory pathway is unlikely because fluoxetine is mature and the molecule’s mechanism is established.

EU/UK context

• Similar pattern: broad approvals, generics in most markets, with local variations in presentation availability and label wording.

What are the key formulation, dosing, and manufacturing issues affecting fluoxetine hydrochloride commercialization?

Featured snippet: Manufacturing consistency and BE robustness drive market access more than clinical novelty.

Common formulation categories in the fluoxetine market

• Immediate-release capsules and tablets
• Liquid oral formulations in certain regions
• Modified-release variants if commercially available (trial programs typically aim here)

Manufacturing/IP barriers that matter commercially

• Solid-state form control and excipient selection that avoids bio-discrepant lots.
• Scale-up robustness for dissolution and uniformity.
• Tight control over moisture sensitivity where relevant to stability.

How does fluoxetine hydrochloride compare with other SSRIs on clinical and market metrics?

Featured snippet: Fluoxetine’s market position is sustained by cost-effective generic access and broad prescriber familiarity; its clinical differentiation is narrower than newer agents.

Competitive set

• Sertraline
• Escitalopram
• Citalopram
• Paroxetine
• Venlafaxine and duloxetine are also competitive at times as SNRI alternatives (market-dependent).

What typically determines class share shifts

• Payer formularies
• Side effect profile preferences
• Pediatric label comfort
• Drug-drug interaction and tolerability patterns as perceived by clinicians

What is the 3- to 7-year market projection for fluoxetine hydrochloride?

Featured snippet: The most likely scenario is low-to-mid single digit revenue growth driven by volume stability and mild price normalization downward; unit growth is modest given maturity and generic competition.

Projection logic (industry-standard)

• Unit volumes: stable demand for antidepressants with replacement of discontinuers by new starts, partially offset by generic substitution.
• Pricing: continues to compress in high-competition strengths; revenue growth can lag units if price declines faster than utilization grows.
• Mix: any rise in preferred dosage forms or region-specific tender allocations can temporarily improve revenue per unit.

Base case (typical mature-generic profile)

• Revenue: modest growth overall
• Margin: pressured by competitive contracting
• Share: stable with periodic re-ranking among suppliers based on tender outcomes

Upside case

• Faster payer acceptance of specific formulations or improved access in high-growth markets.
• Temporary supply constraints among certain competitors that raise contracted prices in the short term.

Downside case

• Additional competitive entries that accelerate price erosion.
• API or intermediate supply shocks that force temporary volume loss for some manufacturers.

What does the clinical trial pipeline imply for investors, licensors, and litigators?

Featured snippet: The pipeline is less about new product economics and more about SKU-level registration, lifecycle management, and quality/regulatory execution.

For investors

• Value creation is most plausible through supplier scale, manufacturing reliability, and contracting execution rather than clinical differentiation.
• Any sponsor owning a defensible modified-release or pediatric-specific formulation can capture localized premium pricing for a period.

For licensors

• Licensing opportunities are tied to formulation IP and manufacturing processes, not fluoxetine’s core mechanism.
• Due diligence should prioritize CMC robustness and BE evidence quality for any candidate variant.

For litigators

• The most active IP disputes for mature generics typically relate to formulation, method-of-use claims (where still present), and manufacturing process allegations.
• The priority is to map claim scope to the exact marketed strength/dosage form and assess design-around feasibility.

Key Takeaways

• Fluoxetine hydrochloride is mature, off primary exclusivity, and driven by generic access and payer contracting.
• Clinical trial activity tends to be formulation, pediatric/label maintenance, and regulatory-facing BE/PK work rather than mechanism innovation.
• Market growth is modest and revenue expansion is mainly mix and tender dynamics, not new patient surges.
• Near-term commercial differentiation is concentrated in specific dosage forms and formulation variants with defensible registration or manufacturing differentiation.
• Generic entry risk is dominated by regulatory quality and supply continuity rather than patent timelines.

FAQs

1) Are there any ongoing Phase 3 trials for fluoxetine hydrochloride that could change its standard-of-care position?
2) What modified-release or formulation variants of fluoxetine are most likely to affect payer formularies?
3) How do biosimilar or biologic market dynamics differ from fluoxetine’s small-molecule generic landscape?
4) Which strengths (e.g., 10 mg, 20 mg, 30 mg, 40 mg) typically drive fluoxetine hydrochloride volume versus revenue?
5) What regulatory events (approvals, labeling updates, safety communications) most influence fluoxetine prescribing patterns in the US?

References

1. FDA. Drug approvals and FDA labeling for fluoxetine-containing products (access via Drugs@FDA).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (search “fluoxetine hydrochloride”).
3. EMA. European public assessment reports for fluoxetine-containing products (EPAR access via product search).
4. WHO. WHO Model List of Essential Medicines and antidepressant guidance.
5. PubMed. Search results for fluoxetine hydrochloride clinical trials and comparative studies.