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Last Updated: January 9, 2025

CLINICAL TRIALS PROFILE FOR ATOMOXETINE HYDROCHLORIDE


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All Clinical Trials for atomoxetine hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00029614 ↗ Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 2006-05-01 The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).
NCT00029614 ↗ Atomoxetine to Treat Adolescents With Coexisting Alcohol and Other Substance Use Disorder and ADHD Completed University of Pittsburgh Phase 2 2006-05-01 The purpose of this study is to compare the effectiveness and safety of atomoxetine in the treatment of adolescents with coexisting alcohol or substance use disorders and Attention Deficit Hyperactivity Disorder (ADHD).
NCT00142961 ↗ Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder Completed National Institute on Drug Abuse (NIDA) Phase 2 2005-10-01 Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
NCT00142961 ↗ Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder Completed New York State Psychiatric Institute Phase 2 2005-10-01 Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
NCT00161031 ↗ Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of Schizophrenia Completed University of Maryland N/A 2004-04-01 The purpose of this study is to: - To examine wether adjunctive atomoxetine is more effective thank placebo for neuropsychological measures of reaction time, motor speed, psychomotor speed, sustained attention, learning and memory, working memory, and executive functioning. To determine the effect size of atomoxetine on these neuropsychological measures for follow-up studies. - To determine if atomoxetine has short-term benefits for improving weight gain and other metabolic abnormalities associated with antipsychotics.
NCT00089869 ↗ A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia Completed Eli Lilly and Company Phase 1/Phase 2 1969-12-31 Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdal, Seroquel, Zyprexa
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for atomoxetine hydrochloride

Condition Name

66151580010203040506070Attention Deficit Hyperactivity DisorderADHDAttention Deficit Disorder With HyperactivityObstructive Sleep Apnea[disabled in preview]
Condition Name for atomoxetine hydrochloride
Intervention Trials
Attention Deficit Hyperactivity Disorder 66
ADHD 15
Attention Deficit Disorder With Hyperactivity 15
Obstructive Sleep Apnea 8
[disabled in preview] 0
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Condition MeSH

1038158130-100102030405060708090100110Attention Deficit Disorder with HyperactivityHyperkinesisDiseaseSleep Apnea, Obstructive[disabled in preview]
Condition MeSH for atomoxetine hydrochloride
Intervention Trials
Attention Deficit Disorder with Hyperactivity 103
Hyperkinesis 81
Disease 58
Sleep Apnea, Obstructive 13
[disabled in preview] 0
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Clinical Trial Locations for atomoxetine hydrochloride

Trials by Country

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Trials by Country for atomoxetine hydrochloride
Location Trials
United States 403
Canada 22
United Kingdom 19
Germany 15
Spain 14
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Trials by US State

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Trials by US State for atomoxetine hydrochloride
Location Trials
New York 27
California 24
Massachusetts 18
Florida 18
Ohio 16
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Clinical Trial Progress for atomoxetine hydrochloride

Clinical Trial Phase

36.4%21.6%40.1%0010203040506070Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for atomoxetine hydrochloride
Clinical Trial Phase Trials
Phase 4 59
Phase 3 35
Phase 2/Phase 3 3
[disabled in preview] 65
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Clinical Trial Status

73.5%7.7%6.6%12.2%0020406080100120140CompletedNot yet recruitingRecruiting[disabled in preview]
Clinical Trial Status for atomoxetine hydrochloride
Clinical Trial Phase Trials
Completed 133
Not yet recruiting 14
Recruiting 12
[disabled in preview] 22
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Clinical Trial Sponsors for atomoxetine hydrochloride

Sponsor Name

trials010203040506070Eli Lilly and CompanyNational Institute on Drug Abuse (NIDA)National Institute of Mental Health (NIMH)[disabled in preview]
Sponsor Name for atomoxetine hydrochloride
Sponsor Trials
Eli Lilly and Company 69
National Institute on Drug Abuse (NIDA) 13
National Institute of Mental Health (NIMH) 9
[disabled in preview] 22
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Sponsor Type

50.5%35.4%12.3%0020406080100120140OtherIndustryNIH[disabled in preview]
Sponsor Type for atomoxetine hydrochloride
Sponsor Trials
Other 140
Industry 98
NIH 34
[disabled in preview] 5
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Atomoxetine hydrochloride Market Analysis and Financial Projection

Atomoxetine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Atomoxetine Hydrochloride

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor, primarily used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It was first approved in the U.S. in 2002 and is widely prescribed for children aged 6 and older, as well as adults[1].

Clinical Trials Overview

The efficacy of atomoxetine hydrochloride has been established through several clinical trials. Here are some key highlights:

  • Pediatric Trials: Four clinical trials lasting 6 to 9 weeks were conducted in pediatric patients (ages 6 to 18). Additionally, a maintenance trial was conducted in pediatric patients (ages 6 to 15)[1].
  • Adult Trials: Two 10-week trials were conducted in adults (age 18 and older)[1].
  • Recent Developments: OWP Pharmaceuticals has received IND authorization from the FDA for the first-ever oral suspension of atomoxetine hydrochloride, offering a new delivery alternative for ADHD treatment[1].

Market Analysis

Current Market Size and Growth

The atomoxetine hydrochloride market has been experiencing significant growth driven by several factors:

  • Global Market Size: The market size was valued at USD 4.7 billion in 2022 and is projected to reach USD 8.5 billion by 2030, growing at a CAGR of 7.5% from 2024 to 2030[3].
  • Regional Dominance: North America, particularly the U.S., holds a major share of the global market, with Europe being the fastest-growing region due to increased awareness and diagnosis of ADHD[5].

Market Segmentation

The atomoxetine hydrochloride market is segmented based on several criteria:

  • Dosage Form: The market includes capsules and oral solutions. The recent introduction of an oral suspension by OWP Pharmaceuticals is expected to expand this segment[1][2].
  • Distribution Channel: The market is segmented by distribution channels, including pharmacies, hospitals, and online platforms[3].
  • Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2][5].

Key Drivers

Several factors are driving the growth of the atomoxetine hydrochloride market:

  • Rising ADHD Prevalence: The increasing global prevalence of ADHD, especially in emerging economies, is a significant driver[3].
  • Expanding Awareness: Growing awareness of ADHD among both children and adults contributes to the demand for atomoxetine hydrochloride[3].
  • Advancements in Formulations: Ongoing advancements in drug formulations, such as the development of oral suspensions, are expected to fuel market growth[1].
  • Government Policies: Favorable government policies promoting mental health awareness and access to medications also play a crucial role[3].

Challenges

Despite the growth, the market faces several challenges:

  • High Cost of Medication: The high cost of atomoxetine hydrochloride is a significant barrier to access, especially in developing regions[3].
  • Alternative Treatment Options: The presence of alternative treatment options for ADHD can also impact market growth[3].

Market Projections

Forecasted Growth

The atomoxetine hydrochloride market is projected to continue its upward trajectory:

  • CAGR: The market is expected to grow at a CAGR of 7.5% from 2024 to 2030[3].
  • Regional Growth: North America is expected to maintain its dominance, while Europe and Asia-Pacific are anticipated to show significant growth due to increasing awareness and improving healthcare infrastructure[5].

Emerging Opportunities

Several opportunities are emerging in the market:

  • Generic Versions: The development of generic versions of atomoxetine hydrochloride is expected to increase market accessibility and affordability[3].
  • Expansion in Emerging Economies: The expansion of distribution channels in emerging economies presents significant growth opportunities[3].

Regulatory Landscape

The atomoxetine hydrochloride market is influenced by various regulatory factors:

  • Drug Approvals: Regulatory approvals, such as the recent IND authorization for the oral suspension, are crucial for market expansion[1].
  • Pricing and Advertising: Regulations related to drug pricing and advertising also impact the market dynamics[3].

Key Players and Research Efforts

  • Pharmaceutical Companies: Companies like OWP Pharmaceuticals are at the forefront of developing new formulations and expanding the market[1].
  • Research and Development: Ongoing research efforts are focused on optimizing production methods, improving drug efficacy, and exploring new formulations, which are driving innovation in the market[5].

Conclusion

The atomoxetine hydrochloride market is poised for significant growth driven by the rising prevalence of ADHD, advancements in drug formulations, and favorable government policies. Despite challenges such as high medication costs and alternative treatment options, the market is expected to expand substantially over the next few years.

Key Takeaways

  • Clinical Trials: The efficacy of atomoxetine hydrochloride has been established through multiple clinical trials in pediatric and adult populations.
  • Market Growth: The market is projected to grow at a CAGR of 7.5% from 2024 to 2030.
  • Regional Dominance: North America and Europe are key regions driving market growth.
  • Emerging Opportunities: Development of generic versions and expansion in emerging economies offer significant growth opportunities.
  • Regulatory Impact: Drug approvals, pricing, and advertising regulations play a crucial role in market dynamics.

FAQs

What is the primary indication for atomoxetine hydrochloride?

Atomoxetine hydrochloride is primarily indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)[4].

What is the current market size of atomoxetine hydrochloride?

The market size was valued at USD 4.7 billion in 2022 and is projected to reach USD 8.5 billion by 2030[3].

What are the key drivers of the atomoxetine hydrochloride market?

Key drivers include the rising prevalence of ADHD, expanding awareness, advancements in drug formulations, and favorable government policies[3].

What challenges does the atomoxetine hydrochloride market face?

The market faces challenges such as the high cost of medication and the presence of alternative treatment options[3].

Which regions are expected to show significant growth in the atomoxetine hydrochloride market?

North America, Europe, and Asia-Pacific are expected to show significant growth due to increasing awareness and improving healthcare infrastructure[5].

Sources

  1. OWP Pharmaceuticals Announces IND Authorization for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride. Biospace, November 17, 2021.
  2. Global Atomoxetine Hydrochloride Market Size, Trends and Forecasts. Market Research Intellect, December 2024.
  3. Atomoxetine Hydrochloride Market Key Drivers and Forecast 2025-2032. GitHub, December 28, 2024.
  4. Atomoxetine Hydrochloride - Drug Targets, Indications, Patents. Synapse, Patsnap.
  5. Global Atomoxetine HCl API Market Report. Cognitive Market Research, July 31, 2024.

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