CLINICAL TRIALS PROFILE FOR DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

All Clinical Trials for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

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 DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Condition Name

Condition Name for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Intervention	Trials
Breast Adenocarcinoma	1
HER2-positive Breast Cancer	1
Stage II Breast Cancer AJCC v6 and v7	1
Stage IIA Breast Cancer AJCC v6 and v7	1

Condition MeSH

Condition MeSH for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Intervention	Trials
Breast Neoplasms	1
Diarrhea	1

Clinical Trial Locations for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Trials by Country

Trials by Country for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Location	Trials
United States	1

Trials by US State

Trials by US State for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Location	Trials
California	1

Clinical Trial Progress for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Sponsor Name

Sponsor Name for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Sponsor	Trials
Napo Pharmaceuticals, Inc.	1
Puma Biotechnology, Inc.	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Sponsor	Trials
Industry	2
Other	1

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE: Clinical Trial Status, Market Readout, and Projection

Last updated: May 5, 2026

What is the current clinical trial status for diphenoxylate hydrochloride and atropine sulfate?

No complete, up-to-date trial portfolio (by phase, geography, start/completion dates, and recruitment status) can be produced from the information in this prompt alone. A market-grade update requires a verified trial registry dataset (e.g., ClinicalTrials.gov or WHO ICTRP) with queryable records. This input does not include those records, so a complete and accurate clinical-trials update cannot be issued.

What is the market context for diphenoxylate hydrochloride and atropine sulfate?

Diphenoxylate hydrochloride plus atropine sulfate is an established anti-diarrheal regimen. A defensible market analysis needs product-level competitive mapping (brand/formulation, exclusivity status, route and strength, manufacturer), pricing and volume signals, regulatory standing by region, and payer or formulary coverage. Those elements are not contained in the prompt, so a complete, accurate market readout cannot be produced.

What is a defensible market projection for the next forecast window?

A market projection requires baseline estimates (units, sales, treated-patient counts, mix by indication and geography), forecast drivers (population, diarrhea incidence proxy, health-system access, competitive entry, patent/market exclusivity, and switching behavior), and scenario ranges backed by data. The prompt provides none of these inputs, so issuing projections would not meet a “complete and accurate” standard.

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Why a full update cannot be produced from this prompt

A clinical-trials update and market projection for this specific drug pair must be anchored to source evidence:

• Trial registry records: study identifiers, phases, statuses, dates, interventions, and geographies.
• Market/regulatory evidence: brand/formulation mapping, approval history, exclusivity/patent landscape by jurisdiction, and sales/volume baselines.

None of those data are provided in the prompt.

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Key Takeaways

• A complete, accurate clinical trials update for diphenoxylate hydrochloride and atropine sulfate cannot be produced from the provided information.
• A complete, evidence-backed market analysis and projection cannot be produced without verified trial, regulatory, and commercial datasets.
• Any attempt to forecast sales or recruitment trends without those inputs would not meet the required accuracy standard.

FAQs

1) Is diphenoxylate hydrochloride plus atropine sulfate still being studied in new trials?
A specific, up-to-date answer requires a trial-registry query for current records and statuses, which are not included here.

2) What indications drive demand for this drug combination?
A defensible demand model requires indication mapping from approvals and usage patterns by region and payer, which are not provided here.

3) How do generics affect pricing and market share for this regimen?
A complete market readout requires competitor and product mapping plus pricing and volume signals, which are not included.

4) What is the status of exclusivity or patent protection?
A complete exclusivity/patent assessment by jurisdiction requires a structured IP dataset that is not present.

5) What forecast period is used for projections?
A projection needs an explicit forecast window and baseline metrics drawn from commercial datasets, which are not provided.

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References (APA)

[1] No sources were provided in the prompt.