CLINICAL TRIALS PROFILE FOR IMODIUM

All Clinical Trials for IMODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00075868 ↗	Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-01	RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00075868 ↗	Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	2003-12-01	RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea. PURPOSE: This randomized phase III trial is studying octreotide in preventing or reducing diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	Bausch Health Americas, Inc.	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00292344 ↗	Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Completed	The University of Texas Health Science Center, Houston	Phase 4	2004-06-01	Most cases of travelers' diarrhea are caused by bacterial pathogens which respond slowly to antibiotic treatment.The study was designed to determine the value of rapidly acting loperamide (imodium) combined with curative dose of the poorly absorbed rifaximin in travelers' diarreha treatment.
NCT00360828 ↗	Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas	Terminated	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2006-02-01	Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine. At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.
NCT00583531 ↗	Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis	Terminated	Ocera Therapeutics	Phase 2	2007-03-01	This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of the study is to assess whether the investigational medication AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An initial group of 10 patients will be enrolled. If there are no serious side effects associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients may be enrolled. Patients will have clinic visits at the start of the study and at week 4. Patients will be checked by phone on a weekly basis for symptom response, compliance and development of side effects. Endoscopies will be performed at the start of the study and at week 4 or early termination.

Clinical Trial Conditions for IMODIUM

Condition Name

Condition Name for IMODIUM
Intervention	Trials
Diarrhea	5
Fecal Incontinence	3
Short Bowel Syndrome	2
Travelers' Diarrhea	2

Condition MeSH

Condition MeSH for IMODIUM
Intervention	Trials
Diarrhea	10
Fecal Incontinence	3
Dysentery	2
Short Bowel Syndrome	2

Clinical Trial Locations for IMODIUM

Trials by Country

Trials by Country for IMODIUM
Location	Trials
United States	59
Mexico	6
Spain	3
India	1
Kenya	1

Trials by US State

Trials by US State for IMODIUM
Location	Trials
California	5
Texas	5
North Carolina	4
New York	2
Missouri	2

Clinical Trial Progress for IMODIUM

Clinical Trial Phase

Clinical Trial Phase for IMODIUM
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IMODIUM
Clinical Trial Phase	Trials
Completed	12
Terminated	5
Active, not recruiting	2

Clinical Trial Sponsors for IMODIUM

Sponsor Name

Sponsor Name for IMODIUM
Sponsor	Trials
M.D. Anderson Cancer Center	2
Johnson & Johnson Consumer and Personal Products Worldwide	2
McNeil AB	2

Sponsor Type

Sponsor Type for IMODIUM
Sponsor	Trials
Other	29
Industry	18
U.S. Fed	4

Last updated: July 28, 2026

Imodium (loperamide) clinical trials update, market analysis, and exclusivity roadmap

Imodium is a long-established, over-the-counter (OTC) brand of loperamide for symptomatic control of acute nonspecific diarrhea. Competitive pressure is structurally high because the active ingredient is off-patent and is widely available in multiple low-cost generic and private-label forms. As a result, commercial upside is driven more by brand execution, formulation differentiation, and distribution mix than by new patent-protected clinical assets.

What clinical trials are running for Imodium (loperamide) right now?

No current, phase-recruiting, sponsor-identified interventional clinical trials for Imodium-branded loperamide were provided in the available inputs for this task. The most recent commercially meaningful trial activity for loperamide historically centers on efficacy and safety comparisons across formulations (capsules vs. liquid), pediatric dosing, and GI tolerability endpoints, often in settings where regulatory labeling updates can be targeted rather than creating enforceable exclusivity.

What trial types have historically been used for loperamide line extensions?

• Bioequivalence and formulation bridging (capsule/liquid, fast-dissolve variants, tamper-resistant packaging).
• Pediatric pharmacology and dosing confirmation tied to label expansion.
• Real-world tolerability studies and post-market safety.
• Acute diarrhea management strategies in emergency or outpatient settings.

Why does that matter for an “Imodium trial update”?

If trials are formulation- or labeling-oriented without a new proprietary mechanism, IP value typically accrues to the specific dosage form and manufacturing process rather than to broad product exclusivity. For OTC loperamide, that usually means limited market impact beyond marginal differentiation.

Is Imodium (loperamide) protected by patents or is it generic-only?

Imodium’s active ingredient, loperamide, is broadly generic. Brand-level value persists without clean, enforceable product exclusivity for the core indication, because many filings relate to specific formulations, packaging, or transient improvements rather than the fundamental compound.

What patent strategy usually exists for OTC loperamide brands?

• Formulation patents: specific excipient systems, release profiles, or taste-masking.
• Method-of-use patents: limited utility in OTC symptomatic products when labeling and standard-of-care are already established.
• Packaging and manufacturing patents: tamper resistance, dosing accuracy, or stability.

Practical outcome for market access

When the compound is off-patent, FDA-market entry friction is typically driven by labeling compliance and formulation bioequivalence rules rather than patent litigation. That pushes competition toward price, availability, and pharmacy trade terms.

When does Imodium lose exclusivity or face generic entry risks?

For a drug whose active ingredient is off-patent and widely marketed, the relevant “exclusivity” is usually:

• the OTC monograph or labeling framework in the US, and
• any formulation-specific exclusivity that could apply to a particular dosage form.

For Imodium specifically, the market is already in a generic equilibrium where new generic entry risk is ongoing but not tied to a single scheduled expiration.

What are the generic entry risk drivers for OTC loperamide?

• Shelf-space and distribution agreements shifting toward lowest net-cost products.
• Retail promotions and channel switching (mass, club, grocery).
• Private-label substitution.
• Availability of equivalent dosage forms (capsules, caplets, liquid).

What is the Orange Book status of Imodium (loperamide)?

Orange Book status for loperamide-based products typically reflects a mature landscape dominated by generics and long-dated approvals. No product-specific Orange Book dataset was included in the available inputs for this task, so no definitive Orange Book listing counts, listed patents, or earliest expiration dates can be stated here.

What patent litigation affects Imodium (loperamide)?

No active or resolved Imodium-branded loperamide patent litigation details were provided in the available inputs for this task. In practice, loperamide litigation risk has generally been lower than for newer, patented small molecules because the compound is widely available and many disputes are centered on narrow formulation and labeling claims rather than large, high-value “blockbuster” portfolios.

How does Imodium compare with competing diarrhea drugs (dosing, efficacy, and market positioning)?

Imodium (loperamide) competes in the symptomatic diarrhea segment against:

• Bismuth subsalicylate products (e.g., Pepto-Bismol) for mild diarrhea and GI upset.
• Oral rehydration solutions (ORS) for dehydration prevention, particularly in infectious diarrhea.
• Probiotics and anti-infective symptom controls in some channels.
• Other antidiarrheals in specific markets, with loperamide remaining the dominant OTC antidiarrheal active in the US.

Commercial comparison that drives share

• Brand trust and shelf recognition.
• Rapid symptom control perception.
• Price and promo cadence in mass channels.
• Pharmacy recommendation and planogram placement.

What is the current market analysis for Imodium (loperamide) in the US and major EU markets?

No quantitative market metrics (current sales, shipment volumes, channel split, or competitor share) were included in the available inputs for this task. The directionally accurate market structure for OTC loperamide is:

• high volume,
• low differentiation at the active-ingredient level,
• intense price competition from generics and private label, and
• brand differentiation concentrated in packaging, convenience, and perceived reliability.

Who typically captures volume under loperamide substitution pressure?

• Generic manufacturers with strong distribution and rebate leverage.
• Private-label offerings in supermarkets, club stores, and large retail chains.
• OTC brands that maintain higher visibility and trade support.

How do formulation variants (capsules, liquids, fast-dissolve) affect Imodium’s commercial outlook?

With off-patent actives, product line management matters. Formulation variants can:

• defend shelf presence against private label,
• support incremental pricing when supported by convenience,
• improve adherence in pediatric or hard-to-swallow segments (where permitted by labeling),
• create defensible IP only at the specific dosage form level.

Where product line expansion usually creates the most ROI

• Fast-dissolve or liquid formats where consumers value speed and ease of dosing.
• Packaging innovations that reduce dosing errors and improve perceived safety.

What is the FDA regulatory pathway for Imodium (loperamide) and how does it affect entry?

Loperamide OTC products generally follow established regulatory frameworks (including labeling compliance and OTC monograph or NDA/ANDA pathways depending on product history and active labeling claims). For generic competition, the key entry barrier is not patent life but:

• labeling alignment,
• formulation equivalence,
• manufacturing compliance (cGMP),
• and any specific pediatric or safety labeling constraints.

What is the biosimilar or biologics angle for Imodium?

None. Imodium is a small-molecule OTC drug (loperamide), so biosimilar frameworks do not apply.

Market projection for Imodium: what growth path is realistic?

No numeric inputs were provided to produce a data-backed forecast (CAGR, year-by-year revenue, unit shipment outlook, or competitor share). A defensible projection for an OTC off-patent loperamide brand is:

• modest top-line growth if brand value holds and incremental trade spend offsets substitution,
• flat-to-declining revenue if private-label and generics capture more shelf space,
• more resilience in pharmacy and convenience retail than in price-led grocery formats.

What levers determine whether Imodium grows or contracts

• Net price after rebates and promotions (trade terms).
• Mix shift into higher-margin variants.
• Channel distribution and planogram defense.
• Regulatory labeling updates that support broader symptom coverage.

Key Takeaways

• Imodium (loperamide) operates in a mature OTC, off-patent active-ingredient market where competition is primarily price and distribution driven.
• A “clinical trials update” for Imodium-branded loperamide is likely to be formulation and labeling-focused; such activity typically does not restore compound-level exclusivity.
• Generic substitution risk is ongoing because active ingredient IP is largely exhausted; any exclusivity tends to be narrow to specific dosage forms.
• Market projection depends on brand execution and mix, not on new blockbuster-style IP-driven barriers.

FAQs

1. Is Imodium OTC in the US, and how does that change its competition profile?
2. Do loperamide formulations (capsules vs. liquid) have different regulatory or market barriers?
3. What labeling limits apply to loperamide for acute diarrhea, and how do they affect competitor claims?
4. How do private-label antidiarrheals typically pressure Imodium net pricing?
5. What non-patent differentiation (packaging, dosing convenience, channel strategy) most affects Imodium market share?

References

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm