CLINICAL TRIALS PROFILE FOR SCOPOLAMINE

All Clinical Trials for Scopolamine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006399 ↗	Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease	Completed	Alzheimer's Association	Phase 2	1999-09-01	The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
NCT00006399 ↗	Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease	Completed	Eisai Inc.	Phase 2	1999-09-01	The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
NCT00006399 ↗	Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease	Completed	Pfizer	Phase 2	1999-09-01	The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
NCT00006399 ↗	Effects of Estrogen on Memory in Post-Menopausal Women and Patients With Alzheimer's Disease	Completed	National Center for Research Resources (NCRR)	Phase 2	1999-09-01	The goal of this study is to examine whether the administration of estrogen to post-menopausal women and women with mild to moderate Alzheimer's disease will enhance their memory and their capacity for learning.
NCT00055575 ↗	Cholinergic Modulation of Condition and Emotion in Mood Disorders: Functional Neuroimaging Studies	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2003-02-27	This study looks at the role of a specific brain chemical system in the mood and attention symptoms seen in major depression and bipolar disorders using functional brain imaging.
NCT00130026 ↗	Caffeine in the Prevention of Post-operative Nausea and Vomiting	Completed	Beth Israel Deaconess Medical Center	N/A	2005-03-01	The objective of this study is to determine if caffeine 500 mg intravenously is efficacious when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.
NCT00369915 ↗	The Antidepressant Efficacy of the Anticholinergic Scopolamine	Terminated	National Institute of Mental Health (NIMH)	Phase 2	2006-08-01	A previous study showed that the intravenous administration of scopolamine produces antidepressant effects. This study is designed to determine if other routes of administration of scopolamine produce antidepressant effects.

Clinical Trial Conditions for Scopolamine

Condition Name

Condition Name for Scopolamine
Intervention	Trials
Motion Sickness	12
Healthy	6
Postoperative Nausea and Vomiting	4
Nausea	4

Condition MeSH

Condition MeSH for Scopolamine
Intervention	Trials
Motion Sickness	15
Vomiting	12
Nausea	10
Depression	8

Clinical Trial Locations for Scopolamine

Trials by Country

Trials by Country for Scopolamine
Location	Trials
United States	57
China	5
France	4
Israel	4
Italy	2

Trials by US State

Trials by US State for Scopolamine
Location	Trials
California	12
Texas	7
Connecticut	5
Ohio	4
Massachusetts	4

Clinical Trial Progress for Scopolamine

Clinical Trial Phase

Clinical Trial Phase for Scopolamine
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Scopolamine
Clinical Trial Phase	Trials
Completed	40
Recruiting	14
Unknown status	9

Clinical Trial Sponsors for Scopolamine

Sponsor Name

Sponsor Name for Scopolamine
Sponsor	Trials
Repurposed Therapeutics, Inc.	11
University of California, Los Angeles	3
Merck Sharp & Dohme Corp.	3

Sponsor Type

Sponsor Type for Scopolamine
Sponsor	Trials
Other	68
Industry	34
NIH	6

Scopolamine: Clinical Trials, Market Analysis, and Projections

Introduction to Scopolamine

Scopolamine, also known as hyoscine or devil's breath, is a tropane alkaloid and anticholinergic medication widely used to treat motion sickness, postoperative nausea and vomiting, and various gastrointestinal issues. Here, we will delve into the latest clinical trials, market analysis, and projections for this versatile drug.

Clinical Trials Update

Defender Pharmaceuticals' Intranasal Scopolamine Gel

Defender Pharmaceuticals has made significant strides in the development of an intranasal scopolamine gel, DPI-386, for the prevention of nausea and vomiting induced by motion in adults. Here are some key updates:

• New Drug Application (NDA) Submission: Defender Pharmaceuticals has submitted its NDA to the FDA based on five Phase III clinical trials, including the overwhelmingly positive results from the Phase 3 study. The FDA's decision on the acceptance of the NDA is anticipated in September 2023, with a prospective PDUFA date in Q1 2024 under an anticipated priority review process[1].
• Collaboration with NASA: Defender is collaborating with NASA on Phase 2 clinical trials to test the anti-nausea gel in astronauts. These trials involve motion simulation exercises to evaluate the gel's efficacy in preventing motion sickness and enhancing sensorimotor performance[4].

Trial Design and Objectives

• The first trial is a randomized, double-blind, placebo-controlled, crossover study involving 30 subjects exposed to simulated wave motion. The second trial will involve about 80 astronaut and ground-control subjects exposed to provocative motion as part of their duties[4].
• These trials aim to bolster the data supporting the use of DPI-386 and potentially expand its applications beyond motion sickness prevention.

Market Analysis

Global Market Size and Growth

The global scopolamine market is poised for significant growth driven by several factors:

• Increasing Surgical Procedures: The market is expected to grow due to an increase in surgical procedures worldwide. The number of surgeries performed annually was estimated to be over 300 million as of 2020, which is a key driver for scopolamine demand[5].
• Expanding Applications: Scopolamine's use in preventing nausea and vomiting post-anesthesia and its emerging role in treating conditions like major depressive disorder are contributing to market expansion[3].

Market Segments and Regional Analysis

• Distribution Channels: The market is segmented by distribution channels, with hospital pharmacies expected to garner a significant share due to the easy availability and growing patient population in hospitals[5].
• Regional Markets: The Asia Pacific region is expected to dominate the market with a majority revenue share by 2037, driven by increasing surgeries in the elderly population and rising healthcare expenditure. North America is anticipated to be the second largest market, driven by research and development in psychological disorders and a well-established healthcare infrastructure[5].

Market Drivers

• Lifestyle and Food Habits: Changing food habits and casual lifestyles affecting the digestive system are significant contributors to the growth of the scopolamine market[2].
• Technological Advancements: The development of synthetic methods for producing scopolamine and ongoing clinical trials enhance its therapeutic potential and adoption across various medical fields[3].

Market Projections

Growth Forecast

• The global scopolamine market was valued at USD 511.78 billion in 2024 and is expected to reach USD 1001.5 billion by 2037, expanding at a CAGR of around 5.3% during the forecast period[5].
• The market is expected to grow significantly in the Asia Pacific and North American regions, driven by increasing healthcare expenditures and the presence of key market players[5].

Segment-Specific Projections

• Transdermal Patch Segment: This segment is anticipated to experience significant growth due to its ease of use and effectiveness in treating motion sickness. The increasing number of surgeries, especially in regions like North America, will drive demand for scopolamine patches[3].
• Hospital Pharmacies: The hospital pharmacies segment is expected to garner a significant share, driven by the easy availability and growing patient population in hospitals[5].

Challenges and Risks

• Side Effects and Misuse: Despite the growth potential, the scopolamine market faces challenges such as side effects and misuse of the drug, as well as stringent regulatory policies[3].
• Regulatory Risks: The process of obtaining regulatory approvals is long and subject to significant risks, which could impact market growth[1].

Key Takeaways

• Clinical Trials: Defender Pharmaceuticals' intranasal scopolamine gel is undergoing significant clinical trials, including collaborations with NASA, to expand its applications.
• Market Growth: The global scopolamine market is expected to grow significantly driven by increasing surgical procedures, expanding applications, and technological advancements.
• Regional Dominance: The Asia Pacific and North American regions are anticipated to dominate the market due to their robust healthcare infrastructure and growing patient base.
• Challenges: The market faces challenges related to side effects, misuse, and regulatory risks.

FAQs

What is the current status of Defender Pharmaceuticals' intranasal scopolamine gel?

Defender Pharmaceuticals has submitted its NDA to the FDA for the intranasal scopolamine gel, DPI-386, based on positive results from five Phase III clinical trials. The FDA's decision on the acceptance of the NDA is anticipated in September 2023[1].

What are the key drivers of the global scopolamine market?

The key drivers include an increase in surgical procedures, expanding applications in treating conditions like major depressive disorder, and technological advancements in production methods[3][5].

Which regions are expected to dominate the scopolamine market?

The Asia Pacific region is expected to dominate the market, followed by North America, driven by increasing healthcare expenditures and a well-established healthcare infrastructure[5].

What are the potential challenges facing the scopolamine market?

The market faces challenges such as side effects and misuse of the drug, as well as stringent regulatory policies that could slow down its growth[3].

How is scopolamine used beyond motion sickness?

Scopolamine is used to treat postoperative nausea and vomiting, stomach and intestine issues such as spastic muscular states, diverticulitis, and irritable bowel syndrome. It is also being researched for its potential in treating psychological disorders and other conditions[2][3].

Sources

1. Defender Pharmaceuticals Announces Submission of New Drug Application to FDA with Intranasal Scopolamine for Prevention of Nausea and Vomiting Induced by Motion in Adults. Biospace.
2. Global Scopolamine Market - 2022-2029. MarketResearch.com.
3. Scopolamine Market Size. Mordor Intelligence.
4. NASA, Defender to test motion sickness gel in new trials. FierceBiotech.
5. Scopolamine Market Size & Share - Growth Report 2037. ResearchNester.