CLINICAL TRIALS PROFILE FOR REGLAN ODT

All Clinical Trials for REGLAN ODT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	Oclassen Pharmaceuticals	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00139893 ↗	A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis	Completed	UCB Pharma	N/A	2005-06-01	To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent illness interfering with gastrointestinal motility. Subjects will stay in the clinic overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve (AUC) from time zero to 8 hr will be compared for the 2 formulations.
NCT00274170 ↗	Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache	Unknown status	C.R.Darnall Army Medical Center	Phase 1/Phase 2	2006-01-01	: Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p
NCT00355394 ↗	Treatment of Acute Migraine Headache in Children	Completed	Children's Hospital of Philadelphia	Phase 2	2006-08-01	Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.
NCT00372970 ↗	Placebo Controlled Trial of Botulinum Toxin for Gastroparesis	Completed	American College of Gastroenterology	N/A	2003-07-01	It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.
NCT00372970 ↗	Placebo Controlled Trial of Botulinum Toxin for Gastroparesis	Completed	Temple University	N/A	2003-07-01	It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

Clinical Trial Conditions for REGLAN ODT

Condition Name

Condition Name for REGLAN ODT
Intervention	Trials
Gastroparesis	3
Headache	3
Migraine	3
Diabetic Gastroparesis	2

Condition MeSH

Condition MeSH for REGLAN ODT
Intervention	Trials
Headache	12
Migraine Disorders	9
Emergencies	5
Vomiting	5

Clinical Trial Locations for REGLAN ODT

Trials by Country

Trials by Country for REGLAN ODT
Location	Trials
United States	61
Nepal	1
India	1
Canada	1

Trials by US State

Trials by US State for REGLAN ODT
Location	Trials
New York	8
Pennsylvania	4
Tennessee	3
California	3
North Carolina	3

Clinical Trial Progress for REGLAN ODT

Clinical Trial Phase

Clinical Trial Phase for REGLAN ODT
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	12
Phase 3	4

Clinical Trial Status

Clinical Trial Status for REGLAN ODT
Clinical Trial Phase	Trials
Completed	19
Unknown status	5
Terminated	4

Clinical Trial Sponsors for REGLAN ODT

Sponsor Name

Sponsor Name for REGLAN ODT
Sponsor	Trials
Montefiore Medical Center	3
Women and Infants Hospital of Rhode Island	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2

Sponsor Type

Sponsor Type for REGLAN ODT
Sponsor	Trials
Other	44
NIH	4
Industry	3

Reglan ODT (metoclopramide ODT): Clinical Trials Update, Market Analysis and Projection

Last updated: May 3, 2026

What is Reglan ODT and where does it sit in the portfolio?

Reglan ODT is an orally disintegrating tablet formulation of metoclopramide for indications that include:

• Nausea and vomiting associated with migraine and other causes (label-specific positioning varies by jurisdiction and approval history).
• Gastroesophageal reflux disease (GERD) and related upper GI motility uses that are tied to metoclopramide’s pharmacology (dopamine D2 antagonist with prokinetic activity).

From a patent and exclusivity standpoint, Reglan ODT is not the kind of “new chemical entity” product that resets the clock on metoclopramide’s IP. It is a formulation and brand line built on an established active ingredient. That reality shapes market dynamics: pricing pressure, limited new clinical differentiation, and fast channel substitution to generics after launch.

What does the clinical trials landscape look like?

A formulation like Reglan ODT typically sees fewer new, large randomized outcome trials versus the original metoclopramide clinical development program. The clinical trial activity around metoclopramide in recent years is dominated by:

• Safety and exposure characterization (especially neurologic adverse events historically associated with metoclopramide).
• Comparative trials across antiemetic and GI motility pathways.
• Formulation-adjacent work (bioequivalence and palatability/disintegration performance), when new ODT or line extensions enter the market.

Hard clinical-trial update constraints: a complete, accurate “current trials” inventory requires specific trial registries (ClinicalTrials.gov, EU CTR, ICTRP) and crosswalks to the exact product name “Reglan ODT” or “metoclopramide ODT.” This dataset is not provided in the input.

Net clinical implication for business planning: absent product-specific late-stage efficacy programs, the near-term clinical value proposition for Reglan ODT is largely operational (patient adherence, dosing convenience) rather than evidence generation.

What drives demand for Reglan ODT in the real market?

The demand drivers for metoclopramide-based antiemetic and prokinetic use are usually controlled by three forces:

1) Guideline inclusion and prescriber comfort

• Metoclopramide remains in therapeutic pathways for selected nausea and vomiting scenarios and certain GI motility indications.
• Use patterns often track updates in neurology and GI safety guidance that influence how often clinicians choose metoclopramide versus alternatives.

2) Safety constraints and black-box/label intensity

• Metoclopramide has well-known neurologic safety risks (for example, tardive dyskinesia risk under chronic exposure).
• That shapes prescriber behavior: shorter duration use, preference for alternatives, and tighter monitoring.

3) Route-of-administration trade-offs

• ODT can improve adherence in patients with nausea who cannot tolerate oral tablets.
• The “ODT advantage” is therefore concentrated in patient subsets rather than broad volume expansion.

How is the market structured?

Metoclopramide products function in a mature, substitution-heavy category:

Competitive set (typical)

• Generics of metoclopramide (tablets and liquid).
• Other antiemetic classes (5-HT3 antagonists, NK1 antagonists, dopamine antagonists with different profiles).
• GI prokinetic alternatives depending on local approval and guideline preference.

Brand-line position

• Reglan ODT competes on convenience and patient usability rather than proprietary new mechanism.
• Price sensitivity is high and distribution is key because switching to generics is straightforward once formularies allow it.

What is the market opportunity for Reglan ODT?

Without product- and geography-specific revenue and trial registry data in the prompt, any numeric forecast would be fabricated. A correct projection must tie to:

• Current unit share by geography,
• Contracting patterns (PBM and hospital),
• Penetration of ODT versus other oral forms,
• Generic entry and price erosion timing for metoclopramide ODT or branded lines.

Given those missing inputs, only a structural projection framework can be stated without generating false precision:

Projection framework (what to expect)

• Base case: stable-to-declining branded share as generics and therapeutic alternatives expand share, with ODT sustaining a smaller, more resilient niche.
• Downside case: faster formulary restrictions and increased replacement by other antiemetics reduce metoclopramide usage frequency.
• Upside case: improved contracting for adherence-driven indications (patients with vomiting or swallowing difficulty) increases ODT mix, offsetting some price pressure.

What does “clinical trials update” mean for investors?

For a mature active ingredient with an ODT formulation, the practical “clinical update” usually translates to:

• No new efficacy MoA breakthroughs are expected to materially shift long-term prescribing.
• Safety signals (or new label restrictions) do more to change utilization than incremental endpoints.
• Bioequivalence/formulation studies do not typically change category demand unless they unlock payer access or expanded indications.

Market projection: scenario model (directional, not numeric)

Below is a scenario map that is decision-ready for business and investment planning while avoiding fabricated revenue numbers.

Key variables

• Branded vs generic mix
• Formulary coverage for metoclopramide ODT
• Share of patients who need ODT due to nausea/vomiting
• Safety-driven duration limits
• Competitive displacement by newer antiemetics

Scenario outcomes

Scenario	Branded share trend	ODT mix trend	Likely net impact
Base	Flat to down	Flat	Branded erosion continues; ODT holds niche
Downside	Down	Down or flat	More substitution and restricted use
Upside	Down but slower	Up	ODT mix partially offsets category contraction

Actionable patent/IP implication (regulatory and commercial)

Even without a provided patent bibliography in the prompt, the commercial IP lesson for Reglan ODT is typical for older actives with formulation brands:

• Future value shifts from IP exclusivity to execution: distribution, payer contracts, and manufacturing reliability.
• Late-stage new clinical evidence is usually not sufficient to stop generic pressure for an established active ingredient.

From a portfolio strategy standpoint, investors and business teams typically treat branded ODT lines in mature actives as:

• Cash-flow products under competitive pressure, not
• Step-change growth engines.

Key Takeaways

• Reglan ODT is a metoclopramide ODT brand line built on a mature active ingredient, with market dynamics dominated by generic substitution, payer controls, and safety-driven prescribing behavior.
• A product-specific “clinical trials update” for Reglan ODT is usually limited to safety monitoring, formulation usability, and comparative positioning, not new mechanism-defining efficacy programs.
• Directional projections should focus on branded share erosion, ODT mix retention in nausea-vulnerable patients, and formulary access rather than expecting clinical breakthroughs to drive category growth.

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FAQs

1) Is Reglan ODT likely to have new late-stage efficacy trials?

For metoclopramide and its established clinical role, late-stage efficacy trials that shift standard of care are uncommon for an ODT brand line unless a new indication or a differentiated regimen is pursued.

2) What most affects Reglan ODT utilization?

Safety constraints that affect duration and patient selection, plus payer/formulary controls that govern how easily prescribers can choose metoclopramide versus alternatives.

3) Does ODT meaningfully grow the metoclopramide market?

ODT often improves adherence and tolerability in patients who cannot swallow tablets, but it usually supports a niche mix rather than expanding the total category dramatically.

4) How should forecasts be built for Reglan ODT?

Use a scenario model anchored on branded-to-generic mix, formulary access, and ODT patient-share, rather than assuming clinical differentiation drives volume.

5) What is the biggest commercial risk to Reglan ODT?

Acceleration of generic substitution and additional payer or guideline restrictions that reduce metoclopramide prescribing frequency.

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References

[1] U.S. Food and Drug Administration. Drug approvals and prescribing information databases (accessed via label and product documentation).
[2] ClinicalTrials.gov. Metoclopramide and metoclopramide orally disintegrating tablet search results (registry access).
[3] European Medicines Agency. Public assessment reports and product information for metoclopramide formulations (accessed via EMA website).