CLINICAL TRIALS PROFILE FOR REGLAN

All Clinical Trials for REGLAN

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for REGLAN

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for REGLAN

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for REGLAN

Sponsor Name

Sponsor Name for REGLAN
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
Sponsor	Trials
Other	44
NIH	4
Industry	3

REGLAN Market Analysis and Financial Projection

Last updated: April 30, 2026

Reglan (metoclopramide) clinical trials update, market analysis, and projections

Reglan is a brand name for metoclopramide, a dopamine D2 receptor antagonist and gastroprokinetic used for nausea/vomiting and gastroparesis. The available clinical-trials and market data are heavily shaped by two facts: (1) metoclopramide is off-patent in major markets, and (2) the product class faces ongoing clinical scrutiny due to tardive dyskinesia risk and mandated risk mitigations in product labeling. (See U.S. prescribing information and FDA safety communications cited below.)

What is the current clinical-trials landscape for Reglan (metoclopramide)?

1) Trial activity is dominated by post-marketing studies and comparative/regimen research

Metoclopramide’s modern clinical evidence base is built around:

• Label-driven indications (acute migraine-associated nausea, diabetic and idiopathic gastroparesis, and chemotherapy/radiation-related nausea per labeling in the relevant geography)
• Safety-focused endpoints tied to extrapyramidal symptoms and tardive dyskinesia risk
• Comparative effectiveness work versus other antiemetics and prokinetics, often using randomized or pragmatic designs

However, the practical value for investment and competitive strategy is constrained by the drug’s generic availability and the low likelihood that new trials will generate IP-renewing differentiation.

2) Safety requirements keep endpoints and inclusion criteria conservative

FDA labeling and boxed-warning style elements drive trial design. Key risk elements include:

• Risk of tardive dyskinesia with longer exposure
• Neuroleptic malignant syndrome warnings
• Extrapyramidal symptoms and other CNS adverse reactions

These constraints affect eligibility, duration, comparator selection, and stopping rules in new studies. (See FDA labeling references below.)

3) Regulatory stance reinforces “lowest effective dose for shortest duration”

U.S. labeling places strong emphasis on limiting exposure time and dose. This is central to trial protocols because it shapes:

• Duration of treatment arms
• Dosing schedules
• Follow-up windows for movement-disorder outcomes

(See prescribing information and FDA communications below.)

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What does the market look like for metoclopramide (Reglan) by demand, pricing, and access?

1) Genericization is the main structural force

Metoclopramide is widely marketed as generics in multiple dosage forms (oral, injectable, and variants depending on country). The commercial implication:

• Brand revenue is typically limited to remaining branded supply arrangements, historical contracts, and geography-specific brand persistence
• Price competition compresses margins
• Uptake depends more on formulary position and hospital procurement than on differentiated clinical superiority

2) Formulary access tracks with safety and stewardship

In many formularies, metoclopramide is still used, but often under:

• Prior authorization or step therapy constraints in chronic use settings
• Safety monitoring requirements in higher-risk populations
• Hard limits on duration aligned to labeling

This reduces utilization for long-term gastroparesis management and channels use into short-course or supervised treatment.

3) Demand is indication- and setting-dependent

Demand drivers typically break along:

• Acute nausea/vomiting episodes: emergency departments, ambulatory infusion settings, and peri-procedural care
• Gastroparesis: specialty GI and endocrinology pathways, but utilization is reduced by risk/benefit scrutiny and alternatives (other prokinetics/antiemetics)

Where hospitals prefer other agents due to tolerability profiles, metoclopramide demand shifts downward.

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How big is the opportunity and where does it sit: short-course use vs. gastroparesis chronicity?

A. Short-course nausea/vomiting

• Higher frequency of acute episodes supports baseline demand
• Safety-related duration guidance still allows use in supervised settings
• Generics keep price low, but volume can sustain economic relevance

B. Gastroparesis

• Treatment often requires repeated courses or longer exposure historically, which conflicts with safety emphasis
• Clinical practice increasingly leans on alternatives, and the utilization window for metoclopramide is narrower
• This segment is the main place where stewardship rules can cap metoclopramide share

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Market projection: 3 scenarios for metoclopramide (Reglan) utilization and revenue

Because Reglan is metoclopramide and faces generic competition, projections should be framed as utilization and unit economics rather than IP-driven growth. The scenarios below describe directional outcomes consistent with regulatory and safety constraints.

Scenario 1: Status quo (base case)

• Utilization stays stable in acute settings
• Gastroparesis use remains under duration and monitoring constraints
• Revenue trends align with volume stability and pricing compression typical for generics

Scenario 2: Restrictive drift (downside)

Triggers:

• Tighter formulary restrictions tied to tardive dyskinesia risk stewardship
• Increased preference for alternative prokinetics/antiemetics
• Higher monitoring burden that reduces default prescribing

Outcome:

• Acute use remains but shifts further toward alternatives
• Gastroparesis share continues to erode

Scenario 3: Stabilization via guideline alignment (upside)

Triggers:

• Clearer clinical pathways that define where metoclopramide is the “default short-course” option
• Improved risk-mitigation programs and decision support that reduce prescriber hesitancy

Outcome:

• Acute use holds while gastroparesis stabilizes at a reduced plateau

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Competitive positioning: what matters most for “Reglan” in 2026 decision-making

1) Safety labeling compliance is the primary “differentiator”

In practice, metoclopramide’s competitive position improves when:

• Clinical workflows ensure exposure limits
• Contraindications and risk screening are operationalized
• Pharmacovigilance and monitoring are standard

2) Procurement and formulary placement decide outcomes

With generics dominating, the brand outcome (where a branded entity remains) depends on:

• Contract pricing with IDNs and wholesalers
• Backorder/reliability of specific forms (injectable shortages can temporarily swing share)
• Local formulary rules on duration and prior authorization

3) Trial strategy cannot change the IP landscape unless it creates a new protected angle

Given off-patent status, only differentiation paths likely to matter are:

• Novel fixed-dose combinations (rare for generic metoclopramide economics)
• New dosage forms or delivery approaches with meaningful clinical advantage
• Device-medicated strategies or digital adherence tools that are hard to replicate quickly

Such plays face steep commercial friction under generic pricing pressure.

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Key takeaways

• Reglan (metoclopramide) clinical activity is still shaped primarily by post-marketing evidence needs and safety endpoint governance, not by new IP-generating paradigms.
• The market is structured by generic competition, with brand performance depending on formulary access, stewardship rules, and procurement contracts.
• The highest-risk demand segment is longer-duration gastroparesis, where utilization tends to cap due to tardive dyskinesia stewardship.
• For projections through the near term, the most defensible view is scenario-based: stable acute use, constrained gastroparesis, and continued pricing pressure.

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FAQs

1. Is Reglan still used for gastroparesis?
   Yes, but prescribing is constrained by FDA safety labeling and movement-disorder risk management, which narrows duration and patient selection.

2. What is the main regulatory risk driving trial design and clinical use?
   Tardive dyskinesia risk, with labeling emphasizing limiting dose and duration and monitoring for extrapyramidal symptoms.

3. Why does genericization suppress growth for Reglan?
   Metoclopramide’s lack of meaningful ongoing patent protection in major markets shifts competition to pricing and formulary access rather than differentiated clinical claims.

4. What setting drives the most consistent demand?
   Acute nausea/vomiting use in emergency and peri-procedural contexts tends to be less constrained than chronic gastroparesis use.

5. What is the most likely determinant of market share next?
   Hospital formulary policies, prior authorization rules, and adherence to “lowest effective dose for shortest duration” protocols.

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References

[1] U.S. Food and Drug Administration. Metoclopramide prescribing information (labeling requirements, safety communications). FDA. https://www.fda.gov/
[2] U.S. Food and Drug Administration. Drug Safety Communications related to metoclopramide and risk of tardive dyskinesia (including labeling/boxed warning evolution). FDA. https://www.fda.gov/