CLINICAL TRIALS PROFILE FOR ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

All Clinical Trials for atropine sulfate; diphenoxylate hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03094052 ↗	Incidence and Severity of Diarrhea in Patients With Stage II-IIIC HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib	Recruiting	Napo Pharmaceuticals, Inc.	Phase 2	2018-10-09	This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.
NCT03094052 ↗	Incidence and Severity of Diarrhea in Patients With Stage II-IIIC HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib	Recruiting	Puma Biotechnology, Inc.	Phase 2	2018-10-09	This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.
NCT03094052 ↗	Incidence and Severity of Diarrhea in Patients With Stage II-IIIC HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib	Recruiting	University of California, San Francisco	Phase 2	2018-10-09	This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.

Clinical Trial Conditions for atropine sulfate; diphenoxylate hydrochloride

Condition Name

Condition Name for atropine sulfate; diphenoxylate hydrochloride
Intervention	Trials
Stage III Breast Cancer AJCC v7	1
Stage IIIA Breast Cancer AJCC v7	1
Stage IIIB Breast Cancer AJCC v7	1

Condition MeSH

Condition MeSH for atropine sulfate; diphenoxylate hydrochloride
Intervention	Trials
Diarrhea	1
Breast Neoplasms	1

Clinical Trial Locations for atropine sulfate; diphenoxylate hydrochloride

Trials by Country

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−

Trials by Country for atropine sulfate; diphenoxylate hydrochloride
Location	Trials
United States	1

Trials by US State

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−

Trials by US State for atropine sulfate; diphenoxylate hydrochloride
Location	Trials
California	1

Clinical Trial Progress for atropine sulfate; diphenoxylate hydrochloride

Clinical Trial Phase

Clinical Trial Phase for atropine sulfate; diphenoxylate hydrochloride
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for atropine sulfate; diphenoxylate hydrochloride
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for atropine sulfate; diphenoxylate hydrochloride

Sponsor Name

Sponsor Name for atropine sulfate; diphenoxylate hydrochloride
Sponsor	Trials
Napo Pharmaceuticals, Inc.	1
Puma Biotechnology, Inc.	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for atropine sulfate; diphenoxylate hydrochloride
Sponsor	Trials
Industry	2
Other	1

Atropine Sulfate and Diphenoxylate Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Atropine sulfate and diphenoxylate hydrochloride are two medications often used in combination to manage diarrhea. Atropine sulfate is an anticholinergic, while diphenoxylate hydrochloride is an antidiarrheal. Here, we will delve into the clinical trials, market analysis, and projections for these drugs.

Clinical Trials and Usage

Diphenoxylate Hydrochloride and Atropine Sulfate

Diphenoxylate hydrochloride and atropine sulfate tablets are indicated for the management of diarrhea in patients 13 years of age and older. The combination works by enhancing segmentation in the gastrointestinal tract, allowing for increased contact between the intestinal mucosa and the intraluminal contents, thereby reducing the frequency of diarrhea[1][5].

Dosage and Efficacy

The initial adult dosage is typically 2 tablets four times daily, with a maximum total daily dose of 20 mg of diphenoxylate hydrochloride. Clinical improvement of acute diarrhea is usually observed within 48 hours. After initial control is achieved, the dosage can be reduced to maintain individual requirements, often with as little as two tablets daily[1][5].

Safety and Contraindications

The use of diphenoxylate hydrochloride and atropine sulfate should be avoided in patients taking monoamine oxidase inhibitors (MAOIs) due to the risk of a hypertensive crisis. It should also be used with caution in patients with advanced hepatorenal disease and those with abnormal liver function, as it may precipitate hepatic coma[1][5].

Market Analysis for Atropine Sulfate

Current Market Size

As of 2023, the atropine sulfate market was valued at over USD 101.36 million. This market is expected to grow substantially, driven by several key factors[3].

Growth Drivers

• Increasing Surgical Procedures: The global rise in surgical services is a significant driver, as atropine sulfate is often used as a preoperative drug.
• Expanding Medical Applications: Atropine sulfate is used in various medical specialties, including gastrointestinal, ophthalmology, neurology, and as an antidote for organophosphate poisoning and bradycardia.
• Advancements in Drug Delivery: Improvements in pharmaceutical formulations and drug delivery systems are enhancing the efficacy and availability of atropine sulfate[3].

Market Projections

The atropine sulfate market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2036, reaching over USD 186.45 million by 2036. North America and the Asia Pacific region are key drivers of this growth, due to their advanced healthcare infrastructure and increasing healthcare investments[3].

Market Analysis for Diphenoxylate Hydrochloride and Atropine Sulfate Combination

Market Size

The diphenoxylate hydrochloride and atropine sulfate tablet market had U.S. sales of approximately $64 million for the 12 months ending May 2018. This market includes both branded and generic versions, such as the generic version launched by Upsher-Smith Laboratories in 2018[2].

Generic Competition

The launch of generic versions, like Upsher-Smith's AA-rated generic version of Lomotil, has increased competition in the market. This competition can affect pricing and market share but also ensures broader accessibility to the medication[2].

Financial Performance and Projections

Revenue Growth

The atropine sulfate market is expected to see significant revenue growth, from USD 105.25 million in 2024 to over USD 186.45 million by 2036. This growth is driven by the increasing demand for atropine sulfate in various medical applications and the advancements in drug delivery systems[3].

Investment and R&D

Companies are investing heavily in research and development to improve drug formulations and delivery systems. This investment is crucial for market expansion and is expected to further boost the growth of the atropine sulfate market[3].

Online Sales and Distribution

Emerging Trends

Online sales are becoming a significant distribution channel for atropine sulfate, particularly for injections. This shift towards online pharmacies is providing accessibility to a broader consumer base and contributing to market expansion[3].

Key Takeaways

• Atropine Sulfate Market Growth: The market is growing significantly due to increasing surgical procedures, expanding medical applications, and advancements in drug delivery.
• Diphenoxylate Hydrochloride and Atropine Sulfate Efficacy: The combination is effective in managing diarrhea, with clinical improvement observed within 48 hours.
• Market Projections: The atropine sulfate market is expected to exceed USD 186.45 million by 2036, growing at a CAGR of 4.8% from 2024 to 2036.
• Regional Drivers: North America and the Asia Pacific region are key drivers of market growth due to their advanced healthcare infrastructure and increasing healthcare investments.
• Online Sales: Online pharmacies are emerging as a significant distribution channel, contributing to market expansion.

FAQs

1. What are the primary applications of atropine sulfate?

Atropine sulfate is used in various medical specialties, including anesthesia, ophthalmology, and as an antidote for organophosphate poisoning and bradycardia[3].

2. Which regions are driving the growth of the atropine sulfate market?

North America and the Asia Pacific region are the primary drivers of market growth, due to their advanced healthcare infrastructure and increasing healthcare investments, respectively[3].

3. What is the projected CAGR for the atropine sulfate market?

The market is expected to grow at a CAGR of 4.8% from 2024 to 2036[3].

4. How are advancements in drug delivery impacting the market?

Improvements in pharmaceutical formulations and drug delivery systems are enhancing the efficacy and availability of atropine sulfate, contributing to market growth[3].

5. What role do online sales play in the atropine sulfate market?

Online sales are becoming increasingly important, providing accessibility to a broader consumer base and contributing to market expansion, especially in regions with limited access to brick-and-mortar pharmacies[3].

Cited Sources

1. Drugs.com: Diphenoxylate and Atropine: Package Insert / Prescribing Info
2. PR Newswire: Upsher-Smith Launches Generic Version of Lomotil
3. DrugPatentWatch: Generic ATROPINE SULFATE INN entry, pharmaceutical patent and market analysis
4. Ipsen: Ipsen's Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma approved by FDA (Not directly relevant but included for completeness)
5. Pfizer: Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, for oral use[5]