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.
NCT03384524 ↗	Evaluation of Bromocriptine, Metoprolol and Tamsulosin in Eyes With Non-Central DME	Withdrawn	Case Western Reserve University	Phase 1/Phase 2	2018-03-01	This phase I/II trial is designed to provide proof of concept evidence that combination therapy can have a beneficial effect on DME and possibly prevent increases in retinal volume or progression of non-central DME into the central subfield of the macula. If a beneficial effect is apparent in this phase I/II study involving a relatively small sample size and short follow-up period, its results could be used to in plan future phase III trials. We believe this study will be the first to show that a systems pharmacology approach can successfully address diabetic macular edema, and thus revolutionize the treatment of complex retinal diseases for which there are a paucity of effective treatment options.

Clinical Trial Conditions for Bromocriptine Mesylate

Condition Name

Condition Name for Bromocriptine Mesylate
Intervention	Trials
Healthy	2
Type 2 Diabetes	2
Diabetic Macular Edema	1
Type 2 Diabetes Mellitus	1

Condition MeSH

Condition MeSH for Bromocriptine Mesylate
Intervention	Trials
Diabetes Mellitus, Type 2	3
Diabetes Mellitus	2
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

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
Phase 3	2
Phase 1/Phase 2	1
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Bromocriptine Mesylate
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1
Terminated	1

Clinical Trial Sponsors for Bromocriptine Mesylate

Sponsor Name

Sponsor Name for Bromocriptine Mesylate
Sponsor	Trials
VeroScience	3
Mylan Pharmaceuticals	2
Case Western Reserve University	1

Sponsor Type

Sponsor Type for Bromocriptine Mesylate
Sponsor	Trials
Industry	5
Other	2

Bromocriptine Mesylate: Clinical Trials, Market Analysis, and Projections

Overview of Bromocriptine Mesylate

Bromocriptine Mesylate is a small molecule drug developed by Novartis AG, primarily targeting dopamine receptors (DRDs). It has been approved for various indications, including Diabetes Mellitus Type 2, infertility, galactorrhea, gigantism, acromegaly, hyperprolactinemia, and Parkinson's disease[1][4].

Clinical Trials Update

Current Status and Phases

Bromocriptine Mesylate has undergone extensive clinical trials across various phases. Here is a summary of its clinical trial status:

• Phase 0: 1 trial
• Phase 1: 9 trials
• Phase 2: 11 trials
• Phase 3: 13 trials
• Phase 4: 9 trials[4].

These trials have been crucial in establishing the safety and efficacy of Bromocriptine Mesylate for its multiple indications.

Recent Developments

While specific recent trials on Bromocriptine Mesylate itself may not be highlighted, the broader context of dopamine agonists and treatments for related conditions is evolving. For example, in the treatment of acromegaly, new drugs like paltusotine (a somatostatin receptor type 2 agonist) and octreotide SC depot (CAM2029) are being developed and have shown positive results in Phase 3 trials[3].

Mechanism of Action and Therapeutic Applications

Dopamine Receptor Agonist

Bromocriptine Mesylate acts as a dopamine D2 and D3 receptor agonist, mimicking the action of dopamine in the brain. This mechanism is crucial for its therapeutic effects in various conditions:

• Diabetes Mellitus Type 2: Regulates blood sugar levels by inhibiting insulin secretion.
• Infertility and Galactorrhea: Reduces prolactin levels, addressing reproductive issues and abnormal milk production.
• Gigantism and Acromegaly: Suppresses growth hormone release, controlling abnormal growth.
• Hyperprolactinemia: Normalizes prolactin levels.
• Parkinson's Disease: Manages motor disorders by stimulating dopamine receptors[1][4].

Market Analysis

Market Size and Growth

The Bromocriptine Mesylate API Sales Market has seen significant growth and is projected to continue this trend. Here are some key market insights:

• Current Market Size: The market reached a value of USD billion in 2023 and is expected to grow substantially by 2031[2].
• Compound Annual Growth Rate (CAGR): The market is anticipated to have a notable CAGR from 2024 to 2031, indicating sustained growth[5].

Market Segmentation

The market is segmented based on type (oral tablets, oral solution, injection) and application (Parkinson's Disease, Hyperprolactinemia, Acromegaly, Diabetes, Others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Drivers and Restraints

The market is driven by several factors:

• Increasing Prevalence of Indications: Conditions like acromegaly and hyperprolactinemia are driving the demand for effective treatments.
• Advancements in Treatment Modalities: Novel therapies and personalized medicine approaches are enhancing market growth[3].
• Geographical Expansion: Countries like China, the United States, and Japan are seeing rapid development in the target DRDs market[1].

However, the market also faces restraints such as regulatory challenges and potential side effects associated with the drug[4].

Market Projections

Forecast Period

The market forecast spans from 2024 to 2031, with a positive outlook due to the increasing demand for Bromocriptine Mesylate and related dopamine agonists.

Regional Analysis

The market is expected to grow significantly in regions such as North America, Europe, and Asia-Pacific. China, in particular, is showing substantial progress in the development and adoption of drugs targeting dopamine receptors[1][2].

Competitive Landscape

The competitive landscape is dynamic, with major players like Novartis AG, Johnson & Johnson, and Mitsubishi Chemical Group Corp. leading the way. The market is also seeing the emergence of new treatments and technologies, such as those from Crinetics Pharmaceuticals and Camurus, which are expected to further drive market growth[1][3].

Key Takeaways

• Clinical Trials: Bromocriptine Mesylate has undergone extensive clinical trials, establishing its safety and efficacy.
• Mechanism of Action: Acts as a dopamine D2 and D3 receptor agonist, treating various conditions related to dopamine and prolactin imbalances.
• Market Growth: The market is projected to grow significantly from 2024 to 2031, driven by increasing demand and advancements in treatment modalities.
• Regional Expansion: Key regions include North America, Europe, and Asia-Pacific, with China showing notable growth.
• Competitive Landscape: Major pharmaceutical companies are leading the market, with new entrants and technologies expected to further drive growth.

FAQs

What are the primary indications for Bromocriptine Mesylate?

Bromocriptine Mesylate is approved for Diabetes Mellitus Type 2, infertility, galactorrhea, gigantism, acromegaly, hyperprolactinemia, and Parkinson's disease[1].

How does Bromocriptine Mesylate work?

It acts as a dopamine D2 and D3 receptor agonist, mimicking the action of dopamine in the brain to achieve therapeutic effects in various conditions[1][4].

What is the current market size and growth projection for Bromocriptine Mesylate API?

The market reached a value of USD billion in 2023 and is expected to grow substantially by 2031, with a notable CAGR from 2024 to 2031[2][5].

Which regions are driving the growth of the Bromocriptine Mesylate market?

Key regions include North America, Europe, and Asia-Pacific, with China showing significant progress[1][2].

What are the major drivers of the Bromocriptine Mesylate market?

Drivers include the increasing prevalence of indications, advancements in treatment modalities, and geographical expansion[1][3].

Who are the major players in the Bromocriptine Mesylate market?

Major players include Novartis AG, Johnson & Johnson, and Mitsubishi Chemical Group Corp., with emerging companies like Crinetics Pharmaceuticals and Camurus also contributing to market growth[1][3].

Sources

1. Decoding Bromocriptine Mesylate: A Comprehensive Study of its R&D Trends - Synapse Patsnap Blog
2. Bromocriptine Mesylate API Sales Market Size, Scope And Forecast - Market Research Intellect
3. Acromegaly Major Markets: Drugs, Epidemiology, Trends, Opportunities, Forecast 2024-2034 - GlobeNewswire
4. Bromocriptine: Uses, Interactions, Mechanism of Action - DrugBank
5. Global Bromocriptine Mesylate API Market Report 2024 Edition - Cognitive Market Research