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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR DESMOPRESSIN ACETATE


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All Clinical Trials for Desmopressin Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00111215 ↗ Treatment and Management of Women With Bleeding Disorders Completed Centers for Disease Control and Prevention N/A 2001-01-01 The purpose of the study is to determine whether oral contraceptives, desmopressin acetate, and/or tranexamic acid are effective in the treatment of women with menorrhagia who are diagnosed with a bleeding disorder.
NCT00477490 ↗ Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia Completed Ferring Pharmaceuticals Phase 3 2007-05-01 The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.
NCT00835211 ↗ Desmopressin Acetate 0.2 mg Tablets, Fasting Completed Teva Pharmaceuticals USA Phase 1 2003-07-01 The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions.
NCT01982760 ↗ DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty Unknown status University Hospitals Cleveland Medical Center Phase 2 2013-12-01 This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.
NCT02538302 ↗ Minirin Versus Oxybutynin for Nocturnal Enuresis in Children Completed Hormozgan University of Medical Sciences Phase 3 2013-07-01 Nocturnal enuresis is among the most common disorders in children. The aim of current study was to compare the efficacy and safety of Minirin and oxybutynin for treatment of nocturnal enuresis in children in Bandar Abbas in 2014.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Desmopressin Acetate

Condition Name

Condition Name for Desmopressin Acetate
Intervention Trials
Mild Hemophilia A Without Inhibitor 1
Nocturia 1
Nocturnal Enuresis 1
Non-Specific Urethritis 1
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Condition MeSH

Condition MeSH for Desmopressin Acetate
Intervention Trials
Enuresis 3
Urinary Incontinence 3
Nocturnal Enuresis 3
Hematologic Diseases 1
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Clinical Trial Locations for Desmopressin Acetate

Trials by Country

Trials by Country for Desmopressin Acetate
Location Trials
United States 34
Canada 4
Egypt 2
China 1
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for Desmopressin Acetate
Location Trials
North Carolina 2
New York 2
New Jersey 2
Georgia 2
Ohio 2
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Clinical Trial Progress for Desmopressin Acetate

Clinical Trial Phase

Clinical Trial Phase for Desmopressin Acetate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Desmopressin Acetate
Clinical Trial Phase Trials
Completed 4
Recruiting 3
Unknown status 2
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Clinical Trial Sponsors for Desmopressin Acetate

Sponsor Name

Sponsor Name for Desmopressin Acetate
Sponsor Trials
Cairo University 2
Haining Health-Coming Biotech Co., Ltd. 1
Genentech, Inc. 1
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Sponsor Type

Sponsor Type for Desmopressin Acetate
Sponsor Trials
Other 8
Industry 3
U.S. Fed 1
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Desmopressin Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Desmopressin acetate is a synthetic analogue of the natural hormone vasopressin, widely used in the treatment of various conditions including nocturnal enuresis, central diabetes insipidus, and certain bleeding disorders. This article delves into the recent clinical trials, market analysis, and future projections for desmopressin acetate.

Clinical Trials Update

Phase 3 Trials for NOCDURNA

The FDA's multi-disciplinary review of NOCDURNA (desmopressin acetate sublingual tablets) highlights several key clinical trials. Three controlled Phase 3 efficacy and safety trials were conducted. In the first Phase 3 trial, CS29, desmopressin acetate at a dose of 100 mcg was statistically superior to placebo in reducing nocturnal voids and achieving a >33% reduction in nocturnal voids. However, lower dose regimens (25 mcg and 50 mcg) showed efficacy in sex-based analyses, although these were not controlled at the overall 5% level of significance[1].

Two additional Phase 3 trials, CS40 and CS41, were conducted to further evaluate the efficacy and safety of the lower dose regimens. These trials confirmed the benefits of desmopressin acetate in reducing nocturnal voids, particularly in patients with nocturnal polyuria[1].

Ongoing Clinical Investigations

Desmopressin is being investigated for novel therapeutic uses, including the management of nocturia and central diabetes insipidus. Ongoing clinical trials are exploring the feasibility of pharmacokinetic-guided dosing due to significant pharmacokinetic variability and the impact of VWF genetic variants on clinical response[4].

Market Analysis

Market Size and Growth

The desmopressin market is experiencing significant growth. As of 2023, the desmopressin market was valued at USD 1.131 billion and is projected to reach USD 1.647 billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031[3].

Market Segmentation

The desmopressin acetate API market is segmented based on type (purity above 98% and below 98%) and application (tablets, injections). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The market dynamics are influenced by drivers such as increasing healthcare expenditure, improvements in drug delivery systems, and growing diagnoses of conditions treated with desmopressin[2].

Key Drivers

  • Improvements in Drug Delivery Systems: Enhancements in drug delivery techniques, such as sublingual tablets and nasal sprays, have improved patient compliance and treatment alternatives, supporting market expansion[3].
  • Growing Healthcare Expenditure: Increased healthcare spending, especially in developing nations, has made desmopressin more accessible, contributing to market growth[3].
  • Pipeline Development and Product Innovation: Ongoing clinical trials for novel therapeutic uses are expanding the market potential for desmopressin-based treatments[3].

Market Projections

Forecast Period

The desmopressin market is anticipated to experience robust growth from 2023 to 2031. The market size is projected to reach USD 2.3 billion by 2030, growing at a CAGR of 9.3% during the forecast period 2024-2030[3].

Regional Growth

The Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a rising number of patients being diagnosed with conditions treatable by desmopressin. Other regions, including North America and Europe, will also contribute to the overall market growth[5].

Competitive Landscape

The global desmopressin acetate tablets market is competitive, with several major manufacturers. The report provides detailed profiles of key companies and their market share, highlighting the competitive landscape and market dynamics[5].

Key Takeaways

  • Clinical Trials: Recent Phase 3 trials have confirmed the efficacy and safety of desmopressin acetate, particularly in the treatment of nocturnal polyuria.
  • Market Growth: The desmopressin market is projected to grow significantly, driven by improvements in drug delivery systems, growing healthcare expenditure, and pipeline development.
  • Regional Expansion: The Asia-Pacific region is expected to be a key driver of market growth.
  • Competitive Landscape: The market is competitive with several major manufacturers, and ongoing innovations are expected to further expand market potential.

FAQs

What are the primary uses of desmopressin acetate?

Desmopressin acetate is primarily used to treat conditions such as nocturnal enuresis, central diabetes insipidus, and certain bleeding disorders.

What are the recent clinical trial findings for desmopressin acetate?

Recent Phase 3 trials have shown that desmopressin acetate is effective in reducing nocturnal voids, particularly in patients with nocturnal polyuria. Lower dose regimens have also shown efficacy in sex-based analyses.

What are the key drivers of the desmopressin market growth?

Key drivers include improvements in drug delivery systems, growing healthcare expenditure, and pipeline development for novel therapeutic uses.

What is the projected market size of desmopressin by 2031?

The desmopressin market is projected to reach USD 1.647 billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031.

Which regions are expected to drive the growth of the desmopressin market?

The Asia-Pacific region, along with North America and Europe, is expected to drive the growth of the desmopressin market due to increasing healthcare expenditure and rising diagnoses of treatable conditions.

Sources

  1. FDA Multi-Discipline Review: NDA 022517 Class 2 Resubmission, NOCDURNA (desmopressin acetate sublingual tablets)[1].
  2. Market Research Intellect: Desmopressin Acetate API Market Size, Scope And Forecast Report[2].
  3. Verified Market Research: In-Depth Industry Outlook: Desmopressin Market Size & Forecast[3].
  4. Spandidos Publications: Potential clinical applications of current and future oral forms of desmopressin[4].
  5. QYResearch: Global Desmopressin Acetate Tablets Market Insights, Forecast to 2030[5].

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