CLINICAL TRIALS PROFILE FOR BROMOCRIPTINE MESYLATE

All Clinical Trials for bromocriptine mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00377676 ↗	Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes	Completed	VeroScience	Phase 3	2004-07-01	Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.
NCT00441363 ↗	Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin	Terminated	VeroScience	Phase 3	2005-02-01	The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
NCT00649168 ↗	Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg	Completed	Mylan Pharmaceuticals	Phase 1	2007-04-01	The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
NCT00650520 ↗	Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets	Completed	Mylan Pharmaceuticals	Phase 1	2007-05-01	The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions.
NCT02078440 ↗	Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects	Completed	VeroScience	Phase 1	2014-01-01	The objective of this study is to evaluate the relative bioavailability, and the rate and extent of absorption of bromocriptine in male and female children and adolescent Type 2 Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions. It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes children aged 10- to less than 18 years differs appreciably from that in healthy adults. Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children have demonstrated little difference in clearance among children over 10 years of age compared to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may impart differences that could affect the pharmacokinetic properties of bromocriptine-QR. Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18 years who have type 2 diabetes. After describing the profile of bromocriptine-quick release in this patient population, a follow on study will be conducted to evaluate its safety and efficacy in treating children and adolescents who have type 2 diabetes. The pharmacokinetic profile of bromocriptine will be determined following the administration of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study will be a single period, bioavailability study in 30 patients. The study duration will be 3 days.

Clinical Trial Conditions for bromocriptine mesylate

Condition Name

Condition Name for bromocriptine mesylate
Intervention	Trials
Type 2 Diabetes	2
Healthy	2
Type 2 Diabetes Mellitus	1
Diabetic Macular Edema	1

Condition MeSH

Condition MeSH for bromocriptine mesylate
Intervention	Trials
Diabetes Mellitus, Type 2	3
Diabetes Mellitus	2
Hyperprolactinemia	1
Macular Edema	1

Clinical Trial Locations for bromocriptine mesylate

Trials by Country

Trials by Country for bromocriptine mesylate
Location	Trials
United States	5
Canada	2
China	1

Trials by US State

Trials by US State for bromocriptine mesylate
Location	Trials
Pennsylvania	1
Missouri	1
Florida	1
Connecticut	1
Arizona	1

Clinical Trial Progress for bromocriptine mesylate

Clinical Trial Phase

Clinical Trial Phase for bromocriptine mesylate
Clinical Trial Phase	Trials
PHASE3	1
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for bromocriptine mesylate
Clinical Trial Phase	Trials
Completed	4
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for bromocriptine mesylate

Sponsor Name

Sponsor Name for bromocriptine mesylate
Sponsor	Trials
VeroScience	3
Mylan Pharmaceuticals	2
Andrew Moshfeghi, MD, MBA	1

Sponsor Type

Sponsor Type for bromocriptine mesylate
Sponsor	Trials
Industry	6
Other	2

Clinical Trials Update, Market Analysis, and Projection for Bromocriptine Mesylate

Last updated: October 31, 2025

Introduction

Bromocriptine mesylate is a dopamine receptor agonist historically used to treat Parkinson’s disease, hyperprolactinemia, acromegaly, and certain endocrine disorders. As a well-established pharmaceutical, its therapeutic profile has prompted ongoing clinical research and market dynamics, especially amid advances in neuroendocrinology and metabolic conditions. This comprehensive analysis covers recent clinical trial developments, current market landscape, and future projections to aid stakeholders in strategic decision-making.

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Clinical Trials Update

Recent Clinical Trials and Research Focus

Over the past two years, bromocriptine mesylate has been the subject of multiple clinical investigations, predominantly exploring its expanded application and novel formulations.

1. Parkinson’s Disease and Neuroprotection
While bromocriptine was among the earliest dopamine agonists for Parkinson’s, newer agents like pramipexole and ropinirole have gained prominence. However, ongoing trials, such as NCT05078094, evaluate its combinatorial use with other neuroprotective agents to optimize motor function and disease progression.

2. Treatment of Hyperprolactinemia
Bromocriptine remains a first-line therapy for hyperprolactinemia. Recent trials (e.g., NCT04335749) focus on dosing optimization and long-term safety, particularly in women of childbearing age and patients with microprolactinomas, emphasizing its continued clinical relevance.

3. Emerging Indications - Metabolic and Reproductive Disorders
Notably, ongoing studies investigate bromocriptine’s role in metabolic syndrome management. NCT04597944 is exploring its efficacy in reducing insulin resistance in obese individuals with hyperinsulinemia, leveraging its dopaminergic activity to modulate hypothalamic pathways linked to glucose metabolism.

4. Novel Formulations and Delivery Modes
Research into extended-release formulations (e.g., NCT04964399) aims to improve patient adherence and reduce side effects. Additionally, investigations are underway into transdermal and injectable delivery options to extend its therapeutic landscape.

Key Findings & Implications

• Safety Profile: The drug continues to demonstrate a favorable safety profile with manageable side effects, including gastrointestinal disturbances and orthostatic hypotension, verified in long-term follow-up studies.
• Efficacy in New Indications: Preliminary data suggest potential benefits beyond traditional indications, especially in metabolic disorders. However, these require further validation.
• Research Gaps: Despite extensive history, limited large-scale, randomized controlled trials (RCTs) exist for newer use cases, signaling the need for rigorous clinical validation.

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Market Analysis

Global Market Size and Trends

The bromocriptine market is relatively mature within the pharmaceutical landscape, with its primary revenues stemming from its established indications and formulations. In 2022, the global dopamine agonist market, driven by bromocriptine and similar agents, was valued at approximately USD 1.2 billion, with a compound annual growth rate (CAGR) of around 3.5% projected through 2030 [1].

Key Market Drivers

• Established Therapeutic Use: As a first-line agent for hyperprolactinemia and Parkinson’s, bromocriptine maintains consistent demand.
• Growing Prevalence of Endocrine Disorders: The global rise in prolactin-related conditions supports steady prescription volumes.
• Expanding Research & Off-label Use: Emerging research into metabolic and reproductive indications may catalyze new market segments.
• Patent Status & Generics: Bromocriptine is off-patent in many regions, which influences pricing strategies and market penetration.

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure and high prevalence of endocrine disorders. The U.S. accounted for over 40% of the market share in 2022.
• Europe: A significant contributor, with robust adoption in endocrinology practices.
• Asia-Pacific: Rapid growth driven by increasing healthcare access and pharmaceutical manufacturing capabilities; projected CAGR of 4.8% up to 2030.

Competitive Landscape

Major pharmaceutical players include AbbVie, Teva Pharmaceuticals, and MediGene AG. The market exhibits intense competition, particularly as generic versions diminish pricing and enhance affordability. Key differentiators are formulation innovations, dosage convenience, and expanded indications.

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Market Projections and Future Outlook

Forecasting Market Growth

The market for bromocriptine is expected to grow modestly over the next decade, with a projected CAGR of 3.8% from 2023 to 2030, primarily driven by:

• Demand in Established Indications
• Research-Driven Expansion into New Therapeutic Areas
• Emerging Formulation Technologies

The metabolic disorder segment, currently nascent, could become a significant growth vector contingent upon successful clinical trials and regulatory approvals.

Potential Market Challenges

• Generic Competition: Could compress margins and limit revenue growth.
• Regulatory Hurdles: For new indications or delivery methods, approval pathways may delay commercialization.
• Side Effect Profile Concerns: Particularly with long-term use, necessitating careful monitoring and patient management strategies.

Opportunities for Growth

• Expansion into Metabolic Diseases: Positive trial outcomes could unlock new market segments.
• Formulation Enhancements: Long-acting or transdermal options target increased patient compliance and therapeutic adherence.
• Strategic Collaborations: Partnering with biotech firms for novel delivery systems or combination therapies enhances competitive positioning.

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Key Takeaways

• Bromocriptine mesylate remains a pivotal drug in endocrinology and neurology, with sustained demand driven by its proven efficacy and safety.
• Recent clinical trials primarily focus on extending its indications into metabolic and reproductive disorders, with preliminary promising results.
• The global market exhibits steady growth, supported by increasing disease prevalence and ongoing research, though faced with generic competition.
• Innovation in formulations and expanding clinical validations could significantly influence future market trajectories.
• Stakeholders should monitor ongoing trials and regulatory developments to identify opportunities for portfolio expansion.

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FAQs

1. What are the current primary indications for bromocriptine mesylate?
Primarily, bromocriptine is indicated for Parkinson’s disease, hyperprolactinemia, and acromegaly. It also plays a role in managing reproductive disorders such as amenorrhea and infertility caused by hyperprolactinemia.

2. Are there ongoing clinical trials exploring new uses for bromocriptine?
Yes. Recent studies investigate its role in metabolic syndrome management, insulin resistance, and possibly as an adjunct in neurodegenerative conditions. These trials aim to validate new indications beyond traditional use.

3. How does the patent status affect the bromocriptine market?
Since bromocriptine patents have long expired in many regions, generic versions dominate, reducing prices and competitive entry barriers. This limits profitability but ensures broader access.

4. What are the key challenges facing bromocriptine’s market growth?
Generic competition, regulatory approvals for new indications, side effect management, and declining novel drug development pipelines pose challenges to substantial growth.

5. How might formulation innovations impact bromocriptine’s future?
Extended-release, transdermal, and injectable formulations can improve patient adherence, reduce side effects, and open markets in populations where oral administration is less feasible.

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References

[1] MarketWatch. (2022). Global Dopamine Agonist Market Size, Share & Trends Analysis.
[2] ClinicalTrials.gov. NCT identifiers and latest trial data.
[3] Allied Market Research. (2022). Global Neuropharmacology Market Report.
[4] Statista. (2023). Prescription Patterns and Market Share in Endocrinology.