CLINICAL TRIALS PROFILE FOR RESERPINE

All Clinical Trials for RESERPINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Institute on Aging (NIA)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
NCT00000514 ↗	Systolic Hypertension in the Elderly Program (SHEP)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1984-06-01	The primary objective was to assess whether long-term administration of antihypertensive therapy to elderly subjects with isolated systolic hypertension reduced the combined incidence of fatal and non-fatal stroke. The secondary objectives were to evaluate: the effect of long-term antihypertensive therapy on mortality from any cause in elderly people with isolated systolic hypertension; possible adverse effects of chronic use of antihypertensive drug treatment in this population; the effect of therapy on indices of quality-of-life; the natural history of isolated systolic hypertension in the placebo population.
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Institute on Aging (NIA)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.
NCT00000499 ↗	Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1980-09-01	The SHEP Pilot Study had six objectives, each designed to develop and test critical components of a full scale trial directed at the health consequences of treating isolated systolic hypertension (ISH) in the elderly. l. To estimate and compare the yield of participants for randomization into a clinical trial from various community groups using various recruitment techniques. 2. To estimate compliance with the visit schedule and to the prescribed double-blind regimens. 3. To estimate and compare the effectiveness of specified antihypertensive medications in reducing the blood pressure. 4. To estimate and compare the unwanted effects of specified antihypertensive medication in an elderly population. 5. To evaluate the feasibility and effectiveness of periodic behavioral assessment in this population. 6. To develop and test methods of ascertaining stroke and other disease endpoints.

Clinical Trial Conditions for RESERPINE

Condition Name

Condition Name for RESERPINE
Intervention	Trials
Hypertension	5
Cardiovascular Diseases	3
Heart Diseases	2
Cocaine-Related Disorders	2

Condition MeSH

Condition MeSH for RESERPINE
Intervention	Trials
Hypertension	6
Cardiovascular Diseases	3
Cocaine-Related Disorders	2
Heart Diseases	2

Clinical Trial Locations for RESERPINE

Trials by Country

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−

Trials by Country for RESERPINE
Location	Trials
United States	22
Canada	2
France	1
Puerto Rico	1
Egypt	1

Trials by US State

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−

Trials by US State for RESERPINE
Location	Trials
Ohio	4
Florida	2
California	2
Tennessee	2
Alabama	1

Clinical Trial Progress for RESERPINE

Clinical Trial Phase

Clinical Trial Phase for RESERPINE
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for RESERPINE
Clinical Trial Phase	Trials
Completed	10
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for RESERPINE

Sponsor Name

Sponsor Name for RESERPINE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	3
National Institute on Aging (NIA)	3
National Heart, Lung, and Blood Institute (NHLBI)	3

Sponsor Type

Sponsor Type for RESERPINE
Sponsor	Trials
NIH	11
Other	8
U.S. Fed	3

Reserpine: Clinical Trials, Market Analysis, and Projections

Overview of Reserpine

Reserpine is an alkaloid derived from the roots of the Rauwolfia serpentina and R. vomitoria plants. It has been used clinically as an antihypertensive and antipsychotic agent, although its use is limited due to significant adverse effects[1].

Mechanism of Action

Reserpine works by inhibiting the synaptic vesicular amine transporter, leading to the depletion of catecholamines (such as norepinephrine) and serotonin from central and peripheral axon terminals. This mechanism is responsible for its antihypertensive and sedative properties[1].

Clinical Trials

Current Status

Reserpine has undergone various clinical trials across different phases, although its current clinical use is restricted due to adverse effects.

• Phase 0-4 Trials: As of the latest data, there are no ongoing Phase 0 trials, two Phase 1 trials, three Phase 2 trials, and two Phase 3 trials. There are no Phase 4 trials currently listed[1].

Historical Context

Historically, reserpine was widely used in the treatment of hypertension and psychiatric disorders. However, due to its side effects, the FDA withdrew its approval for oral dosage forms containing more than 1 mg of reserpine[1].

Market Analysis

Market Size and Growth

The reserpine market is experiencing steady growth, driven by several key factors:

• Increasing Prevalence of Hypertension and Mental Health Disorders: The global rise in hypertension and mental health disorders is a primary driver. According to the World Health Organization (WHO), hypertension affects over 1 billion people worldwide, and mental health disorders account for a significant portion of the global disease burden[3].
• Demand for Natural and Herbal Remedies: The trend towards natural and herbal remedies is enhancing the appeal of reserpine, derived from the Rauwolfia plant[2].
• Cost-Effectiveness: Reserpine is a cost-effective solution, particularly in developing countries where access to newer medications is limited by economic constraints[3].

Market Projections

The reserpine market is projected to grow significantly:

• Valuation: The market is expected to grow from USD 9.65 Billion in 2024 to USD 15.61 Billion by 2031, with a compound annual growth rate (CAGR) of 7.11%[2].
• Regional Growth: Asia-Pacific, Latin America, and the Middle East and Africa are emerging as key regions, driven by large populations, rising disposable incomes, and increasing urbanization[2][3].

Key Players

Prominent players in the reserpine market include:

• Teva
• Yunpeng Pharmaceutical
• Sun Simiao High-tech Pharmaceutical
• Neptunus Zhongxin
• Changchun Dazheng Pharmaceutical

These companies are involved in strategic partnerships, mergers, and acquisitions to consolidate their market positions and expand their product portfolios[2].

Market Trends

Advancements in Drug Formulation and Dosage

Recent trends include innovations in drug delivery systems, such as extended-release formulations and combination therapies, aimed at improving patient outcomes and reducing side effects. These advancements are likely to drive further growth in the reserpine market[3].

Market Expansion in Developing Regions

Countries in Asia, Africa, and Latin America are witnessing increased demand for affordable medications like reserpine. Government initiatives aimed at improving healthcare access and the growing prevalence of chronic conditions are supporting this market expansion[3].

Focus on Sustainable and Ethical Production

The pharmaceutical industry is increasingly focusing on sustainable and ethical practices in the production of reserpine. This includes optimizing production to minimize environmental impact and ensuring the sustainable harvest of Rauwolfia plants[3].

Investment Opportunities

Emerging Markets

The reserpine market presents significant investment opportunities, particularly in emerging markets where the demand for affordable healthcare solutions is rising. Strategic partnerships and innovations in drug delivery are driving investment interest[3].

Ongoing Research

Ongoing research into new therapeutic applications of reserpine, including its potential use in neurodegenerative diseases and combination therapies, could further expand the market and introduce new therapeutic options[3].

Challenges and Limitations

Adverse Effects

Despite its therapeutic benefits, reserpine's clinical use is limited by its adverse effects, which include potential carcinogenicity, reproductive harm, and other significant side effects[1].

Regulatory Hurdles

The FDA's withdrawal of approval for high-dose oral formulations of reserpine highlights the regulatory challenges faced by this drug[1].

Key Takeaways

• Reserpine is an alkaloid with antihypertensive and antipsychotic properties, derived from Rauwolfia plants.
• The drug's market is growing due to increasing demand for affordable treatments for hypertension and mental health disorders.
• Innovations in drug formulation and dosage, along with market expansion in developing regions, are driving growth.
• The market is projected to reach USD 15.61 Billion by 2031, with a CAGR of 7.11%.
• Key players are engaging in strategic partnerships and research to expand the drug's therapeutic applications.

FAQs

What are the primary therapeutic uses of reserpine?

Reserpine is used as an antihypertensive and antipsychotic medication, helping to manage conditions like hypertension and certain psychiatric disorders[1].

What are the key drivers of the reserpine market?

The growth of the reserpine market is driven by the increasing prevalence of hypertension and mental health disorders, the trend towards natural remedies, and the drug's cost-effectiveness[2][3].

Which regions are seeing significant growth in the reserpine market?

Asia-Pacific, Latin America, and the Middle East and Africa are emerging as key regions due to large populations, rising disposable incomes, and increasing urbanization[2][3].

What are the challenges facing the reserpine market?

The market faces challenges such as adverse effects, regulatory hurdles, and economic factors that can impact demand and supply[1][2].

Are there ongoing research and development efforts for reserpine?

Yes, ongoing research is exploring new therapeutic applications of reserpine, including its potential use in neurodegenerative diseases and combination therapies[3].

Sources

1. DrugBank Online: Reserpine: Uses, Interactions, Mechanism of Action.
2. OpenPR: Reserpine Market Size, Share and Forecast By Key Players-Teva, Yunpeng Pharmaceutical, Sun Simiao High-tech Pharmaceutical, Neptunus Zhongxin, Changchun Dazheng Pharmaceutical.
3. Market Research Intellect: Reserpine Market Sees Growth Amid Rising Demand in Pharma and Healthcare.