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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR MINIRIN


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All Clinical Trials for Minirin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00209261 ↗ A 6-week Open Label Cross-over Study With 2 Different Daily Doses of MinirinĀ® Oral Lyophilisate in Children and Adolescents With Primary Nocturnal Enuresis (PNE) Completed Ferring Pharmaceuticals Phase 4 2004-12-01 To evaluate the preference of subjects for MinirinĀ® oral lyophilisate treatment compared with MinirinĀ® tablet treatment after 6 weeks. To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data. To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations
NCT00592566 ↗ Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis Terminated Thailand Research Fund Phase 2/Phase 3 2003-07-01 Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand. Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
NCT00592566 ↗ Desmopressin and Dexamethasone Adjunctive Treatment for Leptospirosis Terminated Mahidol University Phase 2/Phase 3 2003-07-01 Background: Pulmonary involvement in leptospirosis has been reported to be on the increase and is emerging as the main cause of death due to leptospirosis in many countries, including Thailand. Methods: A prospective randomized controlled trial of desmopressin or high dose dexamethasone as adjunctive therapy in patients with suspected pulmonary hemorrhage associated with leptospirosis was conducted between July 2003 and October 2006 at 5 hospitals in Thailand.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Minirin

Condition Name

Condition Name for Minirin
Intervention Trials
Nocturia 5
Nocturnal Enuresis 4
Central Diabetes Insipidus 1
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Condition MeSH

Condition MeSH for Minirin
Intervention Trials
Nocturnal Enuresis 6
Enuresis 6
Urinary Incontinence 5
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Clinical Trial Locations for Minirin

Trials by Country

Trials by Country for Minirin
Location Trials
Japan 26
Thailand 1
Belgium 1
Germany 1
China 1
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Clinical Trial Progress for Minirin

Clinical Trial Phase

Clinical Trial Phase for Minirin
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Minirin
Clinical Trial Phase Trials
Completed 10
Terminated 2
Recruiting 1
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Clinical Trial Sponsors for Minirin

Sponsor Name

Sponsor Name for Minirin
Sponsor Trials
Ferring Pharmaceuticals 6
Hormozgan University of Medical Sciences 1
Ankara Training and Research Hospital 1
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Sponsor Type

Sponsor Type for Minirin
Sponsor Trials
Other 10
Industry 6
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Minirin: Clinical Trials, Market Analysis, and Projections

Introduction to Minirin

Minirin, also known as desmopressin, is a synthetic analogue of the natural hormone vasopressin. It is widely used in the treatment of various conditions, including central diabetes insipidus, nocturnal enuresis (bedwetting), and nocturia (frequent nighttime urination).

Clinical Trials and Efficacy

Nocturia Treatment

A significant clinical trial highlighted the efficacy of oral desmopressin (Minirin) in treating nocturia in women. The study involved a dose-titration period followed by a double-blind phase, where patients received either desmopressin or a placebo. The results showed that 46% of patients on desmopressin had a 50% or greater reduction in nocturnal voids compared to 7% on the placebo, indicating its effectiveness and tolerability[4].

Safety and Adverse Effects

In another study, the safety profile of Minirin was evaluated in a bioequivalence study comparing Minirin tablets to DDAVP tablets. The study found no new safety concerns, with the most common adverse effects being gastrointestinal disorders such as abdominal discomfort, nausea, and headaches. However, it is important to note that hyponatremia, a condition of low sodium levels in the blood, is a potential risk associated with desmopressin use, particularly with the nasal formulation[1].

Market Analysis

Market Size and Forecast

The desmopressin market, which includes Minirin, is projected to experience significant growth. As of 2023, the market size was valued at approximately USD 1.13 billion and is expected to reach USD 1.65 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period 2024-2031[2].

Market Segmentation

The market is segmented based on application and distribution channels. The geriatric use segment is anticipated to grow significantly, while retail pharmacies are expected to dominate the distribution channel segment due to increasing patient footfall[2].

Drivers and Opportunities

Key drivers of the desmopressin market include the growing prevalence of diabetes and increased awareness about the conditions treated by desmopressin. Additionally, ongoing clinical trials exploring new therapeutic uses, such as the management of nocturia and central diabetes insipidus, are expanding the market potential. Increased investments by market players also contribute to the market's growth[3].

Challenges

Despite the growth potential, the market faces challenges such as low awareness and underdiagnosis of the conditions treated by desmopressin. Price sensitivity and disruptions in the supply chain can also impact market demand. Competition from alternative therapies for diseases like von Willebrand disease, nocturnal enuresis, and diabetes insipidus further constrains market expansion[2].

Export and Global Distribution

Export Data

Minirin exports have shown varied trends. According to recent data, there was a decline in exports from March 2023 to February 2024 compared to the previous year, with a notable year-on-year decline in February 2024. However, India, Turkey, and Switzerland are among the top exporters of Minirin, with India leading the global exports[5].

Key Export Destinations

The primary destinations for Minirin exports include Singapore, Sri Lanka, and Libya. This global distribution highlights the drug's widespread use and demand across different regions[5].

Regulatory and Safety Updates

Labeling Changes

Recent regulatory updates include changes to the labeling of desmopressin products to reflect the risk of hyponatremia, particularly with the nasal formulation. The removal of the nocturnal enuresis indication from the nasal formulation and adjustments to the dosing recommendations have also been implemented[1].

Safety Monitoring

Periodic safety updates and cumulative reviews of worldwide safety data have been conducted to monitor the safety profile of desmopressin. These reviews have identified rare cases of emotional disorders, including aggression in children, although these are not deemed sufficient to warrant new labeling at this time[1].

Conclusion

Minirin, or desmopressin, is a crucial medication with a strong clinical efficacy profile, particularly in treating nocturia and other related conditions. The market for desmopressin is expected to grow significantly, driven by increasing awareness and the exploration of new therapeutic uses. However, it faces challenges related to awareness, diagnosis, and competition from alternative therapies.

Key Takeaways

  • Clinical Efficacy: Minirin is effective in treating nocturia and other conditions, with a favorable safety profile.
  • Market Growth: The desmopressin market is projected to grow at a CAGR of 5.3% from 2024 to 2031.
  • Market Segmentation: The market is segmented by application (pediatric and geriatric use) and distribution channels (hospital, retail, and online pharmacies).
  • Export Trends: India, Turkey, and Switzerland are leading exporters of Minirin, with key destinations including Singapore, Sri Lanka, and Libya.
  • Regulatory Updates: Labeling changes and safety monitoring are ongoing to address risks such as hyponatremia.

FAQs

What is Minirin used for?

Minirin, or desmopressin, is used to treat conditions such as central diabetes insipidus, nocturnal enuresis (bedwetting), and nocturia (frequent nighttime urination).

What are the common adverse effects of Minirin?

Common adverse effects include gastrointestinal disorders like abdominal discomfort, nausea, and headaches. Hyponatremia is a more serious potential risk.

How is the desmopressin market expected to grow?

The desmopressin market is projected to reach USD 1.65 billion by 2031, growing at a CAGR of 5.3% during the forecast period 2024-2031.

What are the key drivers of the desmopressin market?

Key drivers include the growing prevalence of diabetes, increased awareness about treated conditions, and ongoing clinical trials exploring new therapeutic uses.

Which countries are the top exporters of Minirin?

India, Turkey, and Switzerland are the top exporters of Minirin, with India leading the global exports.

Sources

  1. FDA Medical Review: "21-795 MEDICAL REVIEW(S) - accessdata.fda.gov"
  2. Verified Market Research: "Desmopressin Market Size & Forecast"
  3. Data Bridge Market Research: "Desmopressin Market Size, Outlook, Trends, Report | Forecast 2030"
  4. PubMed: "Efficacy of desmopressin (Minirin) in the treatment of nocturia"
  5. Volza: "Minirin Exports from World - Volza"

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