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Gastroparesis Treatments Compared

Name: Gastroparesis Treatments Compared
Creator: Jason Hunter
Published: 2026-10-13

1 FDA-approved drug in 2 forms, plus 1 in development, 1 approved only outside the U.S. and 1 turned down by the FDA, side by side from the current prescribing labels. Newest label Feb 2026. Checked October 13, 2026.

Gastroparesis is not rare; Trial Friend includes it because it is part of several rare diseases and domperidone had been available in the U.S. only through FDA expanded access.

The full Gastroparesis guide, with open trials and help paying →

Metoclopramide, FDA-approvedReglan · Gimoti

Metoclopramide is the only drug the FDA has approved for gastroparesis, sold as Reglan tablets, generic tablets and Gimoti nasal spray, and both labels cover adults with diabetic gastroparesis. Both carry a boxed warning for tardive dyskinesia, a movement disorder that can be irreversible, and both say to avoid treatment longer than 12 weeks. The nasal spray is absorbed through the nose instead of being swallowed, and its label rests on studies of the oral drug rather than its own efficacy trial. Domperidone, used in Canada and other countries, is not FDA-approved, and the FDA said its U.S. expanded access supply would end after September 2025. Deudomperidone, a modified domperidone, has finished 2 Phase 2 trials, and the FDA declined to approve tradipitant for gastroparesis in 2024.

Side by side

2 approved gastroparesis treatments at a glance

How each drug is given, how often, who it is approved for and when it was first approved, from the current FDA label.

Gastroparesis treatments compared: route, schedule, approved use and approval date
Drug	How it is given	How often	Approved for	First approved
Reglan metoclopramide tablets (generics from several makers) ANI Pharmaceuticals; generics from several makers	Tablet by mouth 4 times a day	10 mg 30 minutes before each meal and at bedtime, up to 40 mg a day; lower doses for older adults, kidney or liver impairment, CYP2D6 poor metabolizers and people taking quinidine; the label says to avoid bupropion, fluoxetine and paroxetine; avoid treatment longer than 12 weeks	Relief of symptoms in adults with acute and recurrent diabetic gastroparesis	December 30, 1980
Gimoti metoclopramide nasal spray Evoke Pharma on the label; Drugs@FDA lists QOL Medical	Nasal spray, 1 spray in 1 nostril up to 4 times a day	15 mg (1 spray) 30 minutes before each meal and at bedtime, up to 4 sprays a day; not recommended as a first treatment at 65 and older, in moderate or severe liver or kidney impairment, with strong CYP2D6 inhibitors or in CYP2D6 poor metabolizers; avoid treatment longer than 12 weeks	Relief of symptoms in adults with acute and recurrent diabetic gastroparesis	June 19, 2020

The calendar

A year on each gastroparesis treatment

Every dose in a year, drawn to the label schedule, so you can see at a glance how often each one is given.

Reglan

By mouth, at home

10 mg 30 minutes before each meal and at bedtime, up to 40 mg a day (no fixed yearly count)

Gimoti

Other, at home

15 mg (1 spray) 30 minutes before each meal and at bedtime, up to 4 sprays a day (no fixed yearly count)

Counts follow the label schedule for a full year on the maintenance dose. Drugs given in cycles or adjusted to blood tests have no fixed count, so their schedule is written out instead.

The evidence

What the pivotal gastroparesis trials showed

The primary result from the trial each FDA approval rests on, as reported on the label.

Before you compare

How to read the gastroparesis trial results

1
Two forms of the same medicine
Reglan and Gimoti are both metoclopramide with the same boxed warning and the same 12-week limit. They differ in how the dose gets in: a tablet swallowed 4 times a day or a spray in 1 nostril 4 times a day. Gimoti is not recommended as a first treatment at 65 and older, or with moderate or severe liver or kidney impairment.
2
Neither label reports a gastroparesis trial result
The current Reglan label has no clinical studies section, and the Gimoti label says its effectiveness rests on studies of oral metoclopramide. The 2022 American College of Gastroenterology guideline gives metoclopramide a conditional recommendation based on low-quality evidence.
3
The rows below the table are not approved here
Domperidone is approved outside the U.S. but not by the FDA, deudomperidone is still in trials, and tradipitant was turned down for gastroparesis. They are listed so you can see where each stands, not as options a U.S. pharmacy can fill.

Gastroparesis pivotal trial results by drug
Drug	Pivotal trial	Primary result
Reglan metoclopramide tablets (generics from several makers) ANI Pharmaceuticals; generics from several makers	The current label, revised February 2026, has no clinical studies section with gastroparesis trial results	Not reported on the current label; the 2022 ACG guideline gives metoclopramide a conditional recommendation based on low-quality evidence
Gimoti metoclopramide nasal spray Evoke Pharma on the label; Drugs@FDA lists QOL Medical	No Gimoti efficacy trial on the label; its effectiveness rests on studies of oral metoclopramide. A 4-week placebo-controlled study of 190 patients using 14 mg is reported for side effects only	The label gives no efficacy result for the nasal spray itself

Safety

Gastroparesis treatment side effects and warnings

Reglan and Gimoti carry a boxed warning, the FDA's strongest. The rest list their main precautions. Side effect rates show how many people in each drug's trials reported each one, whether or not the drug caused it.

Gastroparesis treatments: most common side effects and key warnings from the FDA labels
Drug	Most common side effects	Key warning
Reglan metoclopramide tablets (generics from several makers) ANI Pharmaceuticals; generics from several makers	restlessness, drowsiness, fatigue and lassitude, together in about 10% at 10 mg 4 times a day	Boxed warning Boxed warning for tardive dyskinesia, a potentially irreversible movement disorder whose risk rises with time and total dose; avoid treatment longer than 12 weeks and stop at the first signs. Not for people with a history of tardive dyskinesia, GI bleeding, blockage or perforation, pheochromocytoma or epilepsy.
Gimoti metoclopramide nasal spray Evoke Pharma on the label; Drugs@FDA lists QOL Medical	taste changes 15% (4% on placebo), headache and fatigue	Boxed warning Same boxed warning as Reglan for tardive dyskinesia, a potentially irreversible movement disorder; avoid treatment longer than 12 weeks.

Not yet approved

Gastroparesis treatments in clinical trials or approved only abroad

Investigational drugs in Phase 1 to 3 trials, plus drugs approved by regulators outside the United States, shown separately because their results are not from an FDA label. Status as of the date in each row.

Gastroparesis drugs not FDA-approved
Drug	Status	How it works and is given	Pivotal trial	Result so far	What is next
domperidone Several makers outside the U.S.	Approved outside the USas of October 13, 2026	Dopamine D2 receptor blocker that acts mainly outside the brainTablet by mouth	No U.S. approval trial; NIDDK Gastroparesis Clinical Research Consortium cohort of 748 patientsPrimary endpoint: Change in gastroparesis symptom scores (observational)	The 181 patients who started domperidone had moderate but statistically significant symptom improvement compared with those who did not (Clinical Gastroenterology and Hepatology, 2022)	Not FDA-approved. The FDA said its expanded access supply would end after September 2025, and a doctor who finds a new supplier can apply again FDA, How to Request Domperidone for Expanded Access Use
deudomperidone (CIN-102) CinDome Pharma	Phase 2as of October 13, 2026	Deuterated, newly formulated domperidoneOral	envisionGI, Phase 2, 416 adults with idiopathic gastroparesis, 15 mg or 10 mg vs placebo for 12 weeks; envision3D, Phase 2, 382 adults with diabetic gastroparesisPrimary endpoint: Nausea severity on the ANMS GCSI-DD nausea subscale over the last 2 weeks of 12 weeks (envisionGI) ClinicalTrials.gov	No trial results published yet	CinDome said topline envisionGI data are expected in late 2026; both trials are listed as completed CinDome Pharma, Business Wire, March 17, 2026
tradipitant Vanda Pharmaceuticals	FDA complete responseas of October 13, 2026	NK-1 receptor antagonist (anti-nausea)Oral	Phase 3 NCT04028492, 979 adults with idiopathic or diabetic gastroparesisPrimary endpoint: Change in daily nausea severity score at week 12 ClinicalTrials.gov	The Phase 3 trial did not meet its primary nausea endpoint, according to results posted on ClinicalTrials.gov; the FDA issued a complete response letter on September 18, 2024, and published its decision on Vanda's hearing request in March 2026	Not approved for gastroparesis; approved as Nereus in December 2025 to prevent vomiting caused by motion FDA, Federal Register, March 31, 2026

Cost

Help paying for gastroparesis treatment

Drugmaker copay and free-drug programs, plus charity funds for the condition, checked every week.

Insurance said no? Your Insurer Denied a Rare Disease Drug and Fewer Than 1 in 100 People Appeal, So Here Is the Playbook · 14 min read

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Questions

Gastroparesis treatment questions people ask

Reglan vs Gimoti: what is the difference for gastroparesis?

Both are metoclopramide with the same boxed warning for tardive dyskinesia and the same 12-week limit, and both are approved for adults with diabetic gastroparesis.

How taken: Reglan is a tablet 30 minutes before each meal and at bedtime, up to 40 mg a day. Gimoti is 1 spray of 15 mg in 1 nostril on the same schedule, up to 4 sprays a day.

Who it is not for: Gimoti is not recommended as a first treatment at 65 and older, in moderate or severe liver or kidney impairment, or with strong CYP2D6 inhibitors.

More: metoclopramide drug page

Source: Gimoti label, FDA

Is domperidone FDA-approved for gastroparesis?

No. Domperidone is not FDA-approved for any use in humans, and in the U.S. it has been available only through FDA expanded access, which a doctor requests. The FDA said that program's supplier would stop distributing it after September 2025, and a doctor who finds a new supplier can apply again.

More: domperidone drug page and what changes for Canadian mail orders on October 22, 2026

Source: FDA, How to Request Domperidone for Expanded Access Use

Why is metoclopramide limited to 12 weeks?

Both labels carry a boxed warning that metoclopramide can cause tardive dyskinesia, a potentially irreversible movement disorder, and that the risk rises with how long and how much you take. The labels say to avoid treatment longer than 12 weeks and to stop at the first signs, such as uncontrolled movements of the face, tongue or limbs.

More: metoclopramide treatment timeline

Source: Reglan label, DailyMed

What new gastroparesis drugs are in development?

Deudomperidone (CIN-102), a modified domperidone from CinDome Pharma, finished 2 Phase 2 trials, and the company expects topline results from the idiopathic gastroparesis trial, envisionGI, in late 2026. Tradipitant, from Vanda Pharmaceuticals, was not approved for gastroparesis after a 2024 complete response letter.

More: deudomperidone drug page and tradipitant drug page

Source: CinDome Pharma, March 17, 2026

What else is used for gastroparesis besides medicine?

The 2022 American College of Gastroenterology guideline starts with diet, including small meals of small-particle, easy-to-digest foods. For symptoms that do not respond to medicine, it describes gastric electrical stimulation, a device the FDA allows under a humanitarian device exemption, and pyloric procedures such as G-POEM.

More: gastroparesis clinical trials

Source: ACG Clinical Guideline: Gastroparesis, 2022

Go deeper

More on Gastroparesis at Trial Friend

Sources

Where every number on this page comes from

Approved-drug facts are from the current FDA prescribing information on DailyMed, with the label's effective date. Investigational-drug facts are from ClinicalTrials.gov and the sources named in each row.

Reglan (metoclopramide tablets (generics from several makers)) prescribing information, ANI Pharmaceuticals; generics from several makers, label dated Feb 2026. DailyMed
Gimoti (metoclopramide nasal spray) prescribing information, Evoke Pharma on the label; Drugs@FDA lists QOL Medical, label dated Feb 2026. DailyMed
domperidone, Several makers outside the U.S.: ; FDA, How to Request Domperidone for Expanded Access Use. Checked October 13, 2026.
deudomperidone (CIN-102), CinDome Pharma: ClinicalTrials.gov record; CinDome Pharma, Business Wire, March 17, 2026. Checked October 13, 2026.
tradipitant, Vanda Pharmaceuticals: ClinicalTrials.gov record; FDA, Federal Register, March 31, 2026. Checked October 13, 2026.

This page compares what the FDA labels and pivotal trials report. It is not medical advice, and no trial on this page compared these drugs with each other. Written and checked by Jason Hunter; the method is on the editorial standards page.