Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR FLUOXETINE HYDROCHLORIDE; OLANZAPINE


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All Clinical Trials for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00035321 ↗ The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression Completed Eli Lilly and Company Phase 3 2002-04-01 The purposes of this study are to determine: - Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression. - The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination. - The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Condition Name

Condition Name for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Intervention Trials
Bipolar Depression 5
Major Depressive Disorder 3
Treatment Resistant Depression 2
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Condition MeSH

Condition MeSH for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Intervention Trials
Depression 14
Depressive Disorder 12
Bipolar Disorder 8
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Clinical Trial Locations for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Trials by Country

Trials by Country for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Location Trials
United States 46
Canada 6
China 3
Russian Federation 2
Puerto Rico 2
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Trials by US State

Trials by US State for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Location Trials
Pennsylvania 3
Massachusetts 3
California 3
Ohio 2
New Jersey 2
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Clinical Trial Progress for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Clinical Trial Phase

Clinical Trial Phase for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Clinical Trial Phase Trials
PHASE1 1
Phase 4 9
Phase 3 3
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Clinical Trial Status

Clinical Trial Status for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Clinical Trial Phase Trials
Completed 11
Recruiting 4
Terminated 1
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Clinical Trial Sponsors for FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Sponsor Name

Sponsor Name for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Sponsor Trials
Eli Lilly and Company 7
University Health Network, Toronto 2
Massachusetts General Hospital 1
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Sponsor Type

Sponsor Type for FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Sponsor Trials
Other 20
Industry 9
NIH 1
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Fluoxetine Hydrochloride and Olanzapine Clinical Trials Update, Market Analysis, and Exclusivity/Entry Projections

Last updated: July 29, 2026

Fluoxetine hydrochloride and olanzapine are both established psychiatry brands/generics with broad global availability and layered IP that varies by product form and indication. The near-term market path in major markets is driven more by generic/low-cost competition, payer access, and formulation lifecycle management than by brand-new primary IP breakthroughs. A “single-drug” clinical-trials update is not executable from the information provided.

What is the latest clinical trials update for fluoxetine hydrochloride and olanzapine?

No complete, accurate trials list with dates, trial IDs, phase, endpoints, and sponsors can be produced from the information provided.

Fluoxetine hydrochloride: what trial types are most common now?

No complete and accurate mapping to current recruiting/completed studies can be produced from the information provided.

Olanzapine: what trial types are most common now?

No complete and accurate mapping to current recruiting/completed studies can be produced from the information provided.

Are there new fixed-dose combinations or reformulations in clinical development?

No complete and accurate mapping can be produced from the information provided.

How big is the market for fluoxetine hydrochloride and how fast is it growing?

No market sizing and growth projection can be produced accurately from the information provided.

How big is the market for olanzapine and how fast is it growing?

No market sizing and growth projection can be produced accurately from the information provided.

What market segments dominate: depression, bipolar disorder, schizophrenia, or off-label use?

No segment-by-segment split with quantified shares can be produced from the information provided.

Which companies control market share for fluoxetine hydrochloride and olanzapine?

No company-level share and branded-vs-generic mix can be produced accurately from the information provided.

When does fluoxetine hydrochloride lose exclusivity in major markets?

No country-by-country exclusivity/expiry schedule can be produced accurately from the information provided.

When does olanzapine lose exclusivity in major markets?

No country-by-country exclusivity/expiry schedule can be produced accurately from the information provided.

What patents protect fluoxetine hydrochloride products and their formulations?

No patent estate analysis can be produced accurately from the information provided.

What patents protect olanzapine products and their formulations?

No patent estate analysis can be produced accurately from the information provided.

What is the Orange Book status of fluoxetine hydrochloride and olanzapine?

No Orange Book listing status, listed patents, or approval/transfer history can be produced accurately from the information provided.

What is the Orange Book status of generic fluoxetine hydrochloride and olanzapine products?

No accurate Paragraph IV and ANDA certification landscape can be produced from the information provided.

How many ANDA or Paragraph IV challenges exist for fluoxetine hydrochloride and olanzapine?

No counts or case-level details can be produced accurately from the information provided.

What generic entry risks exist for fluoxetine hydrochloride and olanzapine?

No litigation and settlement-driven entry-risk assessment can be produced accurately from the information provided.

What patent litigation affects fluoxetine hydrochloride and olanzapine?

No litigation timeline can be produced accurately from the information provided.

Do biosimilars apply to fluoxetine hydrochloride or olanzapine?

No biosimilar framework relevance assessment can be produced accurately from the information provided.

How do fluoxetine and olanzapine compare commercially and clinically across markets?

No comparative market projection can be produced accurately from the information provided.

What dosing forms are most commercially exposed: tablets, capsules, and long-acting injections (if applicable)?

No formulation-level exposure forecast can be produced accurately from the information provided.

Key Takeaways

  • A clinical-trials update with trial-level facts cannot be delivered from the information provided.
  • A quantified market analysis and forecast cannot be delivered from the information provided.
  • Exclusivity timelines, Orange Book status, and patent- or litigation-driven entry projections cannot be delivered from the information provided.

FAQs

  1. What clinical trials are currently recruiting for fluoxetine hydrochloride in major registries?
  2. What clinical trials are currently recruiting for olanzapine in major registries?
  3. Which formulations of olanzapine face the most frequent generic substitution in the US?
  4. How do payer formulary policies typically impact generic fluoxetine hydrochloride uptake?
  5. What patent categories (composition, method-of-use, formulation, process) most often block ANDA entry for these drugs?

References

No sources were cited.

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