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Last Updated: April 2, 2025

CLINICAL TRIALS PROFILE FOR ERGOLOID MESYLATES


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All Clinical Trials for ERGOLOID MESYLATES

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT05030129 ↗ Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome Not yet recruiting Elizabeth Berry-Kravis Phase 2 2021-09-15 A preliminary assessment of the safety, tolerability and efficacy of Ergoloid mesylates (EM) and 5-hydroxytryptophan (5-HTP) and the combination (EM + 5-HTP) compared to placebo in males aged 18-45 years old with Fragile X Syndrome.
NCT01475578 ↗ Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency) Completed Sinphar Pharmaceutical Co., Ltd Phase 2 2002-03-01 The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for ERGOLOID MESYLATES

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1Fragile X SyndromeVascular Dementia[disabled in preview]
Condition Name for ERGOLOID MESYLATES
Intervention Trials
Fragile X Syndrome 1
Vascular Dementia 1
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1DementiaSyndromeFragile X SyndromeDementia, Vascular[disabled in preview]
Condition MeSH for ERGOLOID MESYLATES
Intervention Trials
Dementia 1
Syndrome 1
Fragile X Syndrome 1
Dementia, Vascular 1
[disabled in preview] 0
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Clinical Trial Locations for ERGOLOID MESYLATES

Trials by Country

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Trials by Country for ERGOLOID MESYLATES
Location Trials
China 1
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Clinical Trial Progress for ERGOLOID MESYLATES

Clinical Trial Phase

100.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 2[disabled in preview]
Clinical Trial Phase for ERGOLOID MESYLATES
Clinical Trial Phase Trials
Phase 2 2
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1CompletedNot yet recruiting[disabled in preview]
Clinical Trial Status for ERGOLOID MESYLATES
Clinical Trial Phase Trials
Completed 1
Not yet recruiting 1
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Clinical Trial Sponsors for ERGOLOID MESYLATES

Sponsor Name

trials000001111111Sinphar Pharmaceutical Co., LtdElizabeth Berry-Kravis[disabled in preview]
Sponsor Name for ERGOLOID MESYLATES
Sponsor Trials
Sinphar Pharmaceutical Co., Ltd 1
Elizabeth Berry-Kravis 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for ERGOLOID MESYLATES
Sponsor Trials
Other 2
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Ergoloid Mesylates: Clinical Trials, Market Analysis, and Projections

Introduction

Ergoloid mesylates, a group of synthetic compounds derived from the ergot alkaloid ergotamine, have been a focus of interest in the pharmaceutical industry for their potential in treating various neurological and cognitive disorders. This article will delve into the current clinical trials, market analysis, and future projections for ergoloid mesylates.

Clinical Trials Update

Fragile X Syndrome Trial

One of the most promising and recent clinical trials involving ergoloid mesylates is the study conducted by Purposeful, a drug repurposing company, in partnership with FRAXA, a non-profit organization dedicated to Fragile X research. This trial, led by Dr. Elizabeth Berry-Kravis at Rush University Medical Center, aims to assess the safety, tolerability, and efficacy of ergoloid mesylates (EM) and 5-hydroxytryptophan (5-HTP), both individually and in combination, in adult males with Fragile X syndrome[1].

  • Participants and Design: The trial includes 15-20 adult men with Fragile X syndrome, aged 18-45. The study consists of a screening period followed by four 4-week single-blind treatment periods.
  • Mechanism of Action: Ergoloid mesylates bind to central nervous system targets such as adrenergic, dopaminergic, and serotonergic receptors, potentially improving alertness and memory. 5-HTP increases serotonin production, which may alleviate symptoms like anxiety and depression associated with Fragile X syndrome.
  • Expectations: The combination of EM and 5-HTP has shown promising results in preclinical studies, completely reversing symptoms in Fragile X mice. This trial is crucial for determining whether this combination can have a similar beneficial effect in humans.

Long-Term Studies in Healthy Elderly

Previous long-term studies have also explored the effects of ergoloid mesylates in healthy elderly volunteers. A three-year study and a five-year study have provided valuable insights into the drug's efficacy and safety.

  • Three-Year Study: This study found that ergoloid mesylates were well tolerated and led to improvements in subjective symptoms such as tiredness and dizziness, as well as better performance on intelligence tests. Cardiovascular parameters and cholesterol levels also showed positive changes[3].
  • Five-Year Study: The five-year study reinforced these findings, showing that ergoloid mesylates maintained physical and mental health in healthy elderly individuals. The drug reduced subjective complaints like dizziness and cardiac symptoms and had a positive impact on psychometric tests[4].

Market Analysis

Current Market Size and Growth

The ergoloid mesylates market has been experiencing significant growth driven by the increasing prevalence of neurological and cognitive disorders.

  • Market Value: As of 2023, the ergoloid mesylates market was valued at approximately USD 200 million and is projected to reach USD 350 million by 2033, growing at a CAGR of 5.7% from 2024 to 2033[5].
  • Geographical Distribution: The market is globally distributed, with North America, particularly the United States, and Europe being leading regions. The Asia-Pacific region is expected to experience the fastest growth due to an increasing elderly population and growing awareness about neurological health[5].

Market Segments

The market is segmented based on type (injection, tablet) and application (hospital, clinic, other), as well as geographical regions.

  • Type and Application: The market dynamics vary significantly across different types and applications. Tablets are a more common form due to their ease of administration, while hospitals and clinics are the primary application areas[2][5].
  • Geographical Regions: Emerging markets in Asia-Pacific, Latin America, and the Middle East and Africa offer significant growth opportunities due to the increasing demand for effective therapies for neurological and cognitive disorders[5].

Market Projections

Future Outlook

The ergoloid mesylates market is poised for continued growth driven by several key factors.

  • Increasing Demand: The growing prevalence of neurological and cognitive disorders, such as dementia and Alzheimer's disease, coupled with an aging global population, drives the demand for effective therapies[5].
  • Technological Advancements: The integration of technological advancements in drug delivery systems and the development of novel formulations with enhanced safety profiles are expected to contribute to market expansion[5].
  • Regional Growth: Emerging markets in regions like Asia-Pacific, Latin America, and the Middle East and Africa are expected to fuel the market's growth as awareness and healthcare infrastructure improve[5].

Challenges and Opportunities

While the market presents several opportunities, it also faces some challenges.

  • Clinical Efficacy Debate: There is ongoing debate about the clinical efficacy of ergoloid mesylates, which may impact market growth. However, ongoing and future clinical trials, such as the one for Fragile X syndrome, could provide clearer evidence of the drug's benefits[1][5].
  • Regulatory Landscape: The evolving regulatory landscape could pose restraints to market growth. However, compliance with regulatory requirements and the exploration of new therapeutic applications can mitigate these challenges[5].

Key Takeaways

  • Clinical Trials: Ergoloid mesylates are being tested in a clinical trial for Fragile X syndrome, showing promise in preclinical studies.
  • Long-Term Studies: Previous studies in healthy elderly volunteers have demonstrated the drug's safety and efficacy in improving cognitive and physical health.
  • Market Growth: The ergoloid mesylates market is expected to grow significantly from 2024 to 2033, driven by increasing demand for neurological and cognitive disorder treatments.
  • Geographical Expansion: Emerging markets in Asia-Pacific, Latin America, and the Middle East and Africa offer substantial growth opportunities.
  • Technological Advancements: Integration of new technologies in drug delivery systems and novel formulations will enhance market growth.

FAQs

What is the current clinical trial focusing on ergoloid mesylates?

The current clinical trial, led by Dr. Elizabeth Berry-Kravis, is focusing on the safety, tolerability, and efficacy of ergoloid mesylates and 5-hydroxytryptophan in adult males with Fragile X syndrome.

What are the primary uses of ergoloid mesylates?

Ergoloid mesylates are primarily used in the treatment of various neurological and cognitive disorders, such as dementia, Alzheimer's disease, and age-related cognitive decline.

What is the projected market size of ergoloid mesylates by 2033?

The ergoloid mesylates market is projected to reach USD 350 million by 2033, growing at a CAGR of 5.7% from 2024 to 2033.

Which regions are expected to drive the growth of the ergoloid mesylates market?

The Asia-Pacific region is expected to experience the fastest growth due to an increasing elderly population and growing awareness about neurological health. North America and Europe are also significant markets.

What challenges might the ergoloid mesylates market face?

The market may face challenges related to the ongoing debate about the clinical efficacy of ergoloid mesylates and the evolving regulatory landscape.

Sources

  1. FRAXA Research Foundation. Purposeful and FRAXA Partnership Leads to Clinical Trial. October 19, 2021.
  2. Market Research Intellect. Ergoloid Mesylates Market Size, Scope And Forecast Report. December 2024.
  3. PubMed. A controlled long-term study with ergoloid mesylates (Hydergine) in healthy elderly volunteers.
  4. PubMed. Effects of long-term ergoloid mesylates ('Hydergine') administration on medical, psychological and electrophysiological variables.
  5. Data Horizon Research. Ergoloid Mesylates Market Size, Share, Growth, Statistics Report 2033. July 18, 2024.

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