CLINICAL TRIALS PROFILE FOR DOSTINEX

All Clinical Trials for DOSTINEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00460616 ↗	Cardiac Valve Complications in Prolactinomas Treated With Cabergoline	Completed	Federico II University		2007-01-01	Dopamine agonists are first-line agents for the treatment of prolactinomas (1) and Parkinson's disease (2). There is evidence supporting a causal relationship between the occurrence of drug-induced "restrictive" valvular heart disease and treatment with pergolide (3): in several cases, the valvulopathy improved when pergolide was discontinued (4). Valvular heart damage has also been reported with the ergot-derived dopamine agonists bromocriptine and cabergoline (5,6). Two recent studies (7,8) have further demonstrated that both pergolide and cabergoline are associated with an increased risk of new cardiac valve regurgitation in patients treated for Parkinson's disease. The valvular abnormalities seen with ergot-derived dopamine agonists are similar to those observed in patients receiving ergot alkaloid agents (such as ergotamine and methysergide) in the treatment of migraine, or fenfluramine and dexfenfluramine in the treatment of obesity. These abnormalities also closely resemble carcinoid-related valvulopathies (9). Cardiac valve disease has never been reported in patients with prolactinomas who require treatment with dopamine-agonists even life-long (1). At variance with patients with Parkinson's disease, patients with prolactinomas are younger and are treated with an average dose of dopamine-agonists that is significantly lower (median bromocriptine dose 5 mg/day and median cabergoline dose 1 mg/week). Because of the young age of treatment beginning (most patients with microprolactinomas start dopamine-agonist treatment in early adulthood), treatment might be continued for over 3 decades: the cumulative risk of low doses of dopamine agonists for such a long period of treatment is currently unknown. To assess the prevalence of cardiac valve disease in patients treated with cabergoline, we wish to perform an echocardiography screening in a large representative sample of patients with prolactinoma who were treated with cabergoline for at least 12 months and in a group of control subjects recruited prospectively. We wish to evaluate the severity of regurgitation for the mitral, aortic, and tricuspid valves. Changes in cardiac valve apparatus was compared with treatment duration and cumulative cabergoline dose.
NCT00653055 ↗	Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions	Completed	Anapharm	Phase 1	2001-08-01	To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00653055 ↗	Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fasting Conditions	Completed	Par Pharmaceutical, Inc.	Phase 1	2001-08-01	To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00652873 ↗	Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions	Completed	Anapharm	Phase 1	2001-07-01	To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00652873 ↗	Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions	Completed	Par Pharmaceutical, Inc.	Phase 1	2001-07-01	To compare the rate and extent of absorption of cabergoline 0.5 mg tablets (test) versus Dostinex (reference)
NCT00033111 ↗	A Study of Cabergoline for the Treatment of Cocaine Dependence - 1	Completed	University of California, Los Angeles	Phase 2	2001-06-01	The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence
NCT00033111 ↗	A Study of Cabergoline for the Treatment of Cocaine Dependence - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2001-06-01	The purpose of this study is to assess cabergoline for the Treatment of Cocaine Dependence

Clinical Trial Conditions for DOSTINEX

Condition Name

Condition Name for DOSTINEX
Intervention	Trials
Infertility	3
Ovarian Hyperstimulation Syndrome	2
Acromegaly	2
Endometriosis	2

Condition MeSH

Condition MeSH for DOSTINEX
Intervention	Trials
Ovarian Hyperstimulation Syndrome	5
Pituitary Neoplasms	4
Pituitary Diseases	4
Infertility	3

Clinical Trial Locations for DOSTINEX

Trials by Country

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Trials by Country for DOSTINEX
Location	Trials
United States	12
Brazil	8
Italy	7
Japan	6
Canada	5

Trials by US State

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−

Trials by US State for DOSTINEX
Location	Trials
California	3
Massachusetts	2
Washington	1
Virginia	1
New York	1

Clinical Trial Progress for DOSTINEX

Clinical Trial Phase

Clinical Trial Phase for DOSTINEX
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for DOSTINEX
Clinical Trial Phase	Trials
Completed	15
Recruiting	4
Unknown status	1

Clinical Trial Sponsors for DOSTINEX

Sponsor Name

Sponsor Name for DOSTINEX
Sponsor	Trials
Par Pharmaceutical, Inc.	2
Benha University	2
Novartis Pharmaceuticals	2

Sponsor Type

Sponsor Type for DOSTINEX
Sponsor	Trials
Other	23
Industry	7
NIH	2

DOSTINEX: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Prolactin-Lowering Efficacy

DOSTINEX (cabergoline) has been extensively studied in clinical trials to evaluate its efficacy in treating hyperprolactinemic disorders. Two key randomized, double-blind, comparative studies were conducted:

• Placebo-Controlled Study: This study involved 168 patients treated with DOSTINEX and 20 patients treated with a placebo. The results showed a dose-related decrease in serum prolactin levels, with prolactin normalization achieved in 29%, 76%, 74%, and 95% of patients receiving 0.125, 0.5, 0.75, and 1.0 mg of DOSTINEX twice weekly, respectively, after 4 weeks of treatment[1][4].

• Comparative Trial with Bromocriptine: In this 8-week study, 223 patients were treated with DOSTINEX (0.5 mg twice weekly) and 236 patients with bromocriptine (2.5 mg twice daily). The study found that prolactin was normalized in 77% of patients treated with DOSTINEX, compared to 59% with bromocriptine. Additionally, restoration of menses occurred in 77% of women treated with DOSTINEX, versus 70% with bromocriptine. Galactorrhea disappeared in 73% of patients treated with DOSTINEX, compared to 56% with bromocriptine[1][4].

Safety and Adverse Events

The safety of DOSTINEX has been evaluated in over 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity. Common adverse events included headache, nausea, and vomiting. The incidence of these events was lower in patients treated with DOSTINEX compared to those treated with bromocriptine[1][4].

Pharmacokinetics

Cabergoline is absorbed quickly, with mean peak plasma levels observed within 2 to 3 hours after a single oral dose. The drug's plasma levels are dose-proportional over the range of 0.5 to 7 mg in both healthy volunteers and patients with Parkinson's disease[1][4].

Market Analysis

Market Size and Growth

The DOSTINEX market is projected to experience significant growth over the coming years. Here are some key market insights:

• Current Market Size: The DOSTINEX market was valued at approximately $1.2 billion in 2023[2].
• Projected Growth: The market is expected to expand from $1.25 billion in 2024 to $1.8 billion by 2032, reflecting a compound annual growth rate (CAGR) of around 4.63% during the forecast period[2].

Market Drivers

Several factors are driving the growth of the DOSTINEX market:

• Increasing Demand for Effective Treatments: The rising demand for effective treatments for hyperprolactinemia and related disorders is a major driver[2].
• Advancements in Healthcare: Ongoing advancements in healthcare and drug development are contributing to market growth[2].
• Growing Prevalence of Related Conditions: The increasing prevalence of conditions such as prolactinomas and infertility issues associated with hyperprolactinemia is also driving market expansion[2].

Regional Trends

The DOSTINEX market exhibits distinct regional trends:

• North America: Leads the market due to advanced healthcare infrastructure and high diagnosis rates[2].
• Europe: Follows closely, driven by robust healthcare systems and significant research activities[2].
• Asia-Pacific: Rapid market growth is fueled by increasing healthcare awareness and expanding access to treatments[2].
• South America and Middle East & Africa: These regions show steady growth, supported by improving healthcare services and rising healthcare investments[2].

Market Projections

Future Trends

Several trends are expected to shape the future of the DOSTINEX market:

• Expanding Application Scope: The increasing use of DOSTINEX in treating conditions beyond hyperprolactinemia, such as Parkinson's disease and other dopamine-related disorders, is expanding its application scope[2].
• Growing Demand in Emerging Markets: Improved healthcare access and rising awareness of prolactin-related conditions in emerging markets are driving demand[2].
• Competition from Generic Versions: The market is seeing heightened competition from generic versions of cabergoline, which are more affordable and accessible[2].
• Advancements in Diagnostic Techniques: Earlier detection and treatment of hyperprolactinemia due to advancements in diagnostic techniques are boosting market expansion[2].

Competitive Landscape

The DOSTINEX market is competitive, with several key players:

• Leading Manufacturers: Companies like Pfizer, Teva, and Mylan are significant players in the market[2].
• Market Share and Rankings: The market is characterized by notable firm rankings, fresh product launches, collaborative ventures, corporate expansions, and acquisitions[2].

Key Takeaways

• Clinical Efficacy: DOSTINEX has demonstrated strong prolactin-lowering efficacy in clinical trials.
• Market Growth: The market is expected to grow significantly, driven by increasing demand for effective treatments and advancements in healthcare.
• Regional Dynamics: North America and Europe lead the market, with Asia-Pacific and other regions showing rapid growth.
• Future Trends: Expanding application scope, growing demand in emerging markets, and competition from generics are key trends shaping the market.

FAQs

What is DOSTINEX used for?

DOSTINEX (cabergoline) is primarily used to treat hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas[4].

What are the common adverse events associated with DOSTINEX?

Common adverse events include headache, nausea, and vomiting, with most being mild or moderate in severity[1][4].

How does DOSTINEX compare to bromocriptine in clinical trials?

DOSTINEX showed higher efficacy in normalizing prolactin levels and restoring menses compared to bromocriptine in clinical trials[1][4].

What is the projected market size of DOSTINEX by 2032?

The DOSTINEX market is projected to reach $1.8 billion by 2032, with a CAGR of around 4.63% from 2024 to 2032[2].

Which regions are driving the growth of the DOSTINEX market?

North America and Europe are leading the market, with rapid growth observed in the Asia-Pacific region due to increasing healthcare awareness and access[2].

Sources

1. Dostinex (cabergoline) tablets label - FDA.
2. Dostinex Market Expected to Grow Significantly by 2024 - OpenPR.
3. Cabergoline Tablets Market Size, Share and Trends [2023-2030] - Verified Market Reports.
4. DOSTINEX® cabergoline tablets - Pfizer.
5. Cabergoline-Market-By-Type:-Projected-Growth-and-Market-Outlook - GitHub.