CLINICAL TRIALS PROFILE FOR LOMOTIL

All Clinical Trials for LOMOTIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00583323 ↗	Diphenoxylate / Atropine to Decrease FDG Activity During F-18 FDG PET	Completed	Mayo Clinic	Phase 3	2003-02-01	2-[18F]-fluoro-2-deoxyD-glucose positron emission tomography (FDG PET) has proven to be a valuable clinical tool for the staging and surveillance of lymphoma.1-6 Occasionally, lymph nodes in the mesentery and retroperitoneum can be difficult to distinguish from normal bowel activity on PET scans despite three-plane and cine maximal image projection (MIP) imaging. This uncertainty limits the clinical usefulness of PET in some cases of lymphoma.7-8 In addition, bowel activity can also hinder interpretation of PET scans in other types of solid tumors including melanoma and colorectal cancer.6,9,10 Our goal is to determine how well diphenoxylate/atropine 5mg/0.05mg (Lomotil) decreases bowel activity and how this decrease impacts clinical decision-making, specifically for lymphoma staging and surveillance. This is a prospective, randomized, double-blinded study involving 60 patients undergoing PET scans for newly diagnosed or recurrent, untreated lymphoma.
NCT00591357 ↗	Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy	Suspended	Michael E. DeBakey VA Medical Center	Phase 4	2007-10-01	To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.
NCT00591357 ↗	Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy	Suspended	VA Medical Center, Houston	Phase 4	2007-10-01	To determine whether symptomatic treatment of the diarrhea in CDAD reduces morbidity and mortality of this serious nosocomial infection in patients who have antibiotic-associated diarrhea. Both C. diff positive and negative patients will be included.
NCT02018653 ↗	CASAD for Severe Diarrhea in the Emergency Department	Terminated	Salient Pharmaceuticals Incorporated	N/A	2013-12-01	The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can help to stop your diarrhea. Researchers also want to know if this drug can help decrease the duration of your diarrhea. In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study drug to learn if the study drug has any real effect.
NCT02018653 ↗	CASAD for Severe Diarrhea in the Emergency Department	Terminated	M.D. Anderson Cancer Center	N/A	2013-12-01	The goal of this clinical research study is to learn if calcium alumina-silicate (CASAD) can help to stop your diarrhea. Researchers also want to know if this drug can help decrease the duration of your diarrhea. In this study, CASAD will be compared to a placebo. A placebo is not a drug. It looks like the study drug but it is not designed to treat any disease or illness. It is designed in this study to be compared with the study drug to learn if the study drug has any real effect.
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.

Clinical Trial Conditions for LOMOTIL

Condition Name

Condition Name for LOMOTIL
Intervention	Trials
Stage II Breast Cancer AJCC v6 and v7	1
Stage IIA Breast Cancer AJCC v6 and v7	1
Stage IIB Breast Cancer AJCC v6 and v7	1
Antibiotic-Associated Diarrhea	1

Condition MeSH

Condition MeSH for LOMOTIL
Intervention	Trials
Diarrhea	3
Colitis	1
Clostridium Infections	1
Syndrome	1

Clinical Trial Locations for LOMOTIL

Trials by Country

Trials by Country for LOMOTIL
Location	Trials
United States	4

Trials by US State

Trials by US State for LOMOTIL
Location	Trials
California	2
Texas	2

Clinical Trial Progress for LOMOTIL

Clinical Trial Phase

Clinical Trial Phase for LOMOTIL
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for LOMOTIL
Clinical Trial Phase	Trials
Suspended	1
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for LOMOTIL

Sponsor Name

Sponsor Name for LOMOTIL
Sponsor	Trials
University of California, San Francisco	1
9 Meters Biopharma, Inc.	1
Naia Pharmaceuticals	1

Sponsor Type

Sponsor Type for LOMOTIL
Sponsor	Trials
Industry	5
Other	3
U.S. Fed	2

Last updated: May 3, 2026

What is the current clinical and market outlook for LOMOTIL (diphenoxylate/atropine)?

What is LOMOTIL’s current clinical development status?

LOMOTIL is an established brand formulation of diphenoxylate hydrochloride + atropine sulfate indicated for treatment of diarrhea. The name “LOMOTIL” is widely marketed for chronic and acute diarrheal control, but current public clinical-trial activity is limited relative to new-drug pipelines because the product is mature and off-patent in most markets.

No complete, up-to-date clinical trials dataset (start/completion status, phase, endpoints, sponsor, sites) is provided in the materials available in this session. As a result, a precise “clinical trials update” by trial and phase cannot be produced here without fabricating trial-level facts.

What is LOMOTIL’s market position and how does it typically compete?

LOMOTIL competes in the antidiarrheal segment, primarily against:

• OTC and prescription anti-diarrheals (for example, loperamide products)
• Disease-specific treatments when diarrhea has an underlying cause (infectious workups, IBD therapies)
• Rehydration and supportive care (oral rehydration solutions)

Market behavior in antidiarrheal classes is shaped by:

• Switching to OTC options where permitted
• Use-case patterns (acute traveler’s diarrhea, antibiotic-associated diarrhea, noninfectious diarrhea)
• Safety and misuse constraints (opioid-related regulatory scrutiny in diphenoxylate class historically influences formulary decisions and payer coverage requirements)

Because LOMOTIL is a mature, branded therapy, its market economics typically depend more on:

• Contracting and channel mix (retail vs institutional)
• Formularies and payer rules
• Availability and generic competition timing than on clinical innovation.

What market forecasts can be projected for a mature antidiarrheal like LOMOTIL?

Without validated, market-research inputs (category size, branded share, geography, channel volume, unit pricing, and reimbursement trends) a numeric projection would require assumptions that cannot be supported with hard data in this response. A defensible forecast requires at least:

• Current category revenue/units by geography
• Branded share and erosion curve (generic entry cadence)
• Price and reimbursement outlook
• Compliance and labeling trends affecting utilization

No such quantified market dataset appears in the current session. A market projection presented as numbers would not meet the required standard of “hard data.”

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What can be stated from patent and exclusivity context (high-level, non-numeric)?

Is LOMOTIL still protected by strong exclusivity?

LOMOTIL is a longstanding product. In major jurisdictions, mature small-molecule combination products commonly face:

• Generic entry after relevant formulation and compound patent expiry
• Short-cycle exclusivities in limited scenarios (line extensions, pediatric, new indications, reformulations) that do not consistently translate into multi-year branded growth

A patent-specific exclusivity status by country cannot be concluded from the provided information here without risking inaccuracies.

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Business implications (actionable, but non-numeric)

What does the current profile mean for forecasting and diligence?

For an investor or R&D committee evaluating LOMOTIL-like assets, the key diligence items typically are:

• Brand vs generic share by geography and channel
• Formulary position (national accounts, PBM placement, step edits)
• Regulatory constraints tied to antidiarrheal misuse and safety wording
• Switch drivers (OTC loperamide substitution, provider preference shifts)
• Supply and contracting risk (manufacturer volume reliability, shortages, distributor terms)

What scenario planning is most relevant for this class?

Forecast sensitivity usually comes from:

• Unit price erosion driven by generic penetration
• Utilization shifts between acute diarrhea etiologies and treated conditions
• Regulatory or label changes that affect clinician willingness to prescribe

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Key Takeaways

• LOMOTIL (diphenoxylate/atropine) is a mature antidiarrheal brand; public clinical development activity is typically limited compared with new chemical entities.
• A trial-by-trial “clinical trials update” and a numeric market projection require hard inputs that are not available in this session, so they cannot be produced without fabricating specifics.
• Near-term business outcomes in this class usually hinge on generic competition, formulary access, pricing, and substitution dynamics rather than new clinical differentiation.

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FAQs

What is LOMOTIL used for?

LOMOTIL is used for treatment of diarrhea.

Is LOMOTIL still undergoing Phase 3 or Phase 2 trials?

A verified, trial-specific update with phase and status cannot be provided from the information available in this session.

How does LOMOTIL compete against loperamide?

It competes in antidiarrheal use cases, but substitution toward commonly available alternatives often pressures branded utilization.

Does LOMOTIL have patent protection today?

A country-by-country exclusivity determination cannot be stated from the information available in this session.

What drives revenue for mature antidiarrheals?

Brand share vs generics, formulary placement, pricing, and channel contracting are typically the primary drivers.

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References

[1] LOMOTIL (diphenoxylate hydrochloride and atropine sulfate) prescribing information. (Source not provided in this session.)