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Last Updated: January 4, 2025

CLINICAL TRIALS PROFILE FOR DUTASTERIDE


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505(b)(2) Clinical Trials for dutasteride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Formulation NCT05599243 ↗ Exploratory Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia. Recruiting Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Phase 2 2022-09-29 Alopecia is a disorder that involves the loss of hair from the body. The causes of hair loss can be multiple, but in all cases this loss causes a lot of discomfort to patients for aesthetic and psychological reasons, especially in the female population.This study is going to focus on the topical use of dutasteride in the treatment of men with androgenic alopecia using a new formulation, as an emulsion, capable of transporting this drug to the different structures of the pilosebaceous unit.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for dutasteride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00146146 ↗ Testosterone and Its Metabolites in GID Completed Schering-Plough Phase 3 2005-05-01 The purposes of this study are: - to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile - to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile
NCT00082043 ↗ Dutasteride to Treat Women With Menstrually Related Mood Disorders Completed National Institute of Mental Health (NIMH) Phase 1 2004-03-31 This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up. Participants undergo the following tests and procedures: - Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo. - Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings. - Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status.
NCT00090103 ↗ Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment Completed GlaxoSmithKline Phase 3 2003-11-01 This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
NCT00062790 ↗ Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels Completed GlaxoSmithKline Phase 4 2003-10-01 This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
NCT00070733 ↗ The Effect of 5-Alpha Reductase on Testosterone in Men Unknown status Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 2003-08-01 The enzyme 5-alpha reductase is present in small amounts in muscle and converts testosterone to dihydrotestosterone (DHT). Testosterone affects lean body tissue, muscle size, muscle strength, and sexual function in men. This study will evaluate how 5-alpha reductase influences the effects of testosterone in young healthy men.
NCT00056407 ↗ "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk Completed GlaxoSmithKline Phase 3 2003-03-01 This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for dutasteride

Condition Name

252220600510152025Prostate CancerProstatic HyperplasiaBenign Prostatic HyperplasiaHypogonadism[disabled in preview]
Condition Name for dutasteride
Intervention Trials
Prostate Cancer 25
Prostatic Hyperplasia 22
Benign Prostatic Hyperplasia 20
Hypogonadism 6
[disabled in preview] 0
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Condition MeSH

45433290051015202530354045Prostatic HyperplasiaHyperplasiaProstatic NeoplasmsAlopecia[disabled in preview]
Condition MeSH for dutasteride
Intervention Trials
Prostatic Hyperplasia 45
Hyperplasia 43
Prostatic Neoplasms 32
Alopecia 9
[disabled in preview] 0
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Clinical Trial Locations for dutasteride

Trials by Country

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Trials by Country for dutasteride
Location Trials
United States 236
Germany 69
United Kingdom 51
Canada 35
Italy 31
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Trials by US State

+
Trials by US State for dutasteride
Location Trials
Washington 16
Massachusetts 14
Maryland 12
Illinois 10
California 10
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Clinical Trial Progress for dutasteride

Clinical Trial Phase

20.7%21.7%5.4%52.2%05101520253035404550Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for dutasteride
Clinical Trial Phase Trials
Phase 4 19
Phase 3 20
Phase 2/Phase 3 5
[disabled in preview] 48
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Clinical Trial Status

76.9%6.5%5.6%11.1%00102030405060708090CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for dutasteride
Clinical Trial Phase Trials
Completed 83
Unknown status 7
Terminated 6
[disabled in preview] 12
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Clinical Trial Sponsors for dutasteride

Sponsor Name

trials051015202530354045505560GlaxoSmithKlineUniversity of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)[disabled in preview]
Sponsor Name for dutasteride
Sponsor Trials
GlaxoSmithKline 58
University of Washington 7
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 5
[disabled in preview] 14
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Sponsor Type

47.2%41.7%10.6%00102030405060708090OtherIndustryNIH[disabled in preview]
Sponsor Type for dutasteride
Sponsor Trials
Other 85
Industry 75
NIH 19
[disabled in preview] 1
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Dutasteride Market Analysis and Financial Projection

Dutasteride: Clinical Trials, Market Analysis, and Projections

Introduction

Dutasteride, sold under the brand name Avodart among others, is a medication primarily used to treat enlarged prostate in men. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials: Efficacy and Safety

Dutasteride in Bladder Cancer Treatment

A recent single-arm, single-center, phase 2 clinical trial investigated the efficacy and safety of dutasteride when added to standard Bacillus Calmette-Guérin (BCG) immunotherapy for preventing recurrence and progression in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC)[1].

  • Key Findings: The study involved 23 patients, with 14 completing the follow-up. Although dutasteride failed to show the predicted efficacy in reducing recurrence, there was a promising decrease in recurrences after the 6th month of treatment, and no patient progressed to muscle-invasive bladder cancer (MIBC).
  • Limitations: The small number of patients and difficulties during the COVID-19 pandemic, including patient withdrawals, were significant limitations.

Prostate Cancer Risk Reduction

The REDUCE (REduction by DUtasteride of prostate Cancer Events) trial, a large, long-term study, demonstrated that dutasteride significantly reduced the risk of all biopsy-detectable prostate cancer by 23% over four years in men at increased risk for prostate cancer[4].

  • Study Design: This international, randomized, double-blind, placebo-controlled trial involved 8,121 men aged 50-75 years.
  • Results: The study showed a significant reduction in prostate cancer risk, with 659 cancers in the dutasteride arm and 857 in the placebo arm.

Topical Dutasteride Clinical Trials

Clinical trials have also explored the use of topical dutasteride, particularly in comparison to oral formulations and other treatments like finasteride.

  • Skin Permeation and Pharmacokinetics: Studies using the Franz Cell Diffusion Test and human pharmacokinetic studies have shown that topical dutasteride can achieve significant skin permeation and reduce serum dihydrotestosterone (DHT) levels, although to a lesser extent than oral dutasteride[5].

Market Analysis

Global Market Overview

The global dutasteride market is anticipated to grow significantly over the forecast period from 2024 to 2030.

  • Market Size: The market was valued at millions of USD in 2023 and is expected to reach millions of USD by 2030, with a compound annual growth rate (CAGR) during this period[2][3].
  • Regional Markets: The North American, European, and Asia-Pacific regions are expected to contribute substantially to the market growth. For instance, the Asia-Pacific market is projected to increase at a notable CAGR during the forecast period[2].

Market Segmentation

The dutasteride market is segmented by type, application, and geography.

  • Type: Dutasteride is available in various forms, including tablets and capsules.
  • Application: The primary applications are in hospitals and drug stores.
  • Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2][3].

Key Manufacturers

Major global manufacturers of dutasteride include GlaxoSmithKline (GSK), Bionpharma, Rising Pharmaceuticals, Teva, Mylan, Zydus, Amneal Pharma, Apotex, and Marksans Pharma. These companies play a significant role in the market's competitive landscape[2].

Market Projections

Growth Drivers

The growth of the dutasteride market is driven by several factors:

  • Increasing Demand: The demand for dutasteride is rising due to its efficacy in treating enlarged prostate and reducing the risk of prostate cancer.
  • Technological Trends: Advances in pharmaceutical technology and new product developments are expected to boost market growth[2][3].

Market Size and Revenue

The global dutasteride API market, for example, was valued at USD 8.61 billion in 2023 and is expected to reach USD 10.22 billion by 2030, growing at a CAGR of 2.91% during the forecast period[3].

Competitive Landscape

The market is competitive, with key players focusing on product innovation, strategic partnerships, and expanding their geographical presence. The top three to five players in the market are evaluated based on their product offerings, financial statements, and market strategies[2][3].

Key Takeaways

  • Clinical Trials: Dutasteride has shown mixed results in clinical trials for NMIBC but significant efficacy in reducing prostate cancer risk.
  • Market Growth: The global dutasteride market is projected to grow substantially over the next few years, driven by increasing demand and technological advancements.
  • Market Segmentation: The market is segmented by type, application, and geography, with major manufacturers playing a crucial role.
  • Competitive Landscape: The market is highly competitive, with key players focusing on innovation and strategic expansion.

FAQs

What is the primary use of dutasteride?

Dutasteride is primarily used to treat enlarged prostate in men.

What were the findings of the REDUCE trial?

The REDUCE trial found that dutasteride significantly reduced the risk of all biopsy-detectable prostate cancer by 23% over four years.

How effective is topical dutasteride?

Topical dutasteride has shown appreciable skin permeation and can reduce serum DHT levels, although to a lesser extent than oral dutasteride.

Who are the major manufacturers of dutasteride?

Major manufacturers include GSK, Bionpharma, Rising Pharmaceuticals, Teva, Mylan, Zydus, Amneal Pharma, Apotex, and Marksans Pharma.

What is the projected growth rate of the global dutasteride market?

The global dutasteride API market is expected to grow at a CAGR of 2.91% from 2023 to 2030.

Sources

  1. Efficacy and Safety of a 5-Alpha Reductase Inhibitor, Dutasteride Added to Bacillus Calmette-Guérin Immunotherapy for Prevention of Recurrence and Progression of Intermediate- and High-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm Phase 2 Clinical Trial. Jurolsurgery.org.
  2. Global Dutasteride Market Research Report 2024. QYResearch.
  3. Dutasteride API Market Size, Forecast | Global Industry Trends [2030]. Verified Market Reports.
  4. Large, long-term study shows dutasteride reduced prostate cancer risk in men at increased risk of the disease. GSK.
  5. Topical Dutasteride Clinical Trial Results. XYON Health.

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