GIMOTI (metoclopramide hydrochloride)
Gimoti helps adults manage the symptoms associated with both acute and recurrent diabetic gastroparesis. This medication is used to provide relief for patients experiencing these digestive complications, though it is not recommended for pediatric use or for those with significant kidney or liver impairment. It is also avoided in patients taking certain medications that inhibit the CYP2D6 enzyme to prevent excessive drug exposure.
How GIMOTI Works
Gimoti works by blocking dopamine-2 receptors and sensitizing digestive tissues to the effects of acetylcholine. This process increases the strength of stomach contractions and relaxes the pyloric sphincter, which helps speed up the movement of food through the stomach and intestines. Additionally, it increases the resting tone of the lower esophageal sphincter to improve overall upper gastrointestinal motility.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-19
- Patent Cliff
- 2038
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
GIMOTI Approval History
What GIMOTI Treats
1 indicationsGIMOTI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetic Gastroparesis
GIMOTI Boxed Warning
TARDIVE DYSKINESIA Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is contraindicated in patients with a history of TD. Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatmen...
WARNING: TARDIVE DYSKINESIA Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions ( 5.1 )] . GIMOTI is contraindicated in patients with a history of TD. Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD [see Warnings and Precautions ( 5.1 )] . Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD [see Warnings and Precautions ( 5.1 )] . WARNING: TARDIVE DYSKINESIA See full prescribing information for complete boxed warning . Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage. ( 5.1 ) GIMOTI is contraindicated in patients with a history of TD. ( 4 ) Use GIMOTI for the shortest duration of treatment and periodically reassess the need for continued treatment. ( 2.2 , 5.1 ) Immediately discontinue GIMOTI in patients who develop signs or symptoms of TD. ( 5.1 ) Avoid a total duration of treatment with metoclopramide products, including GIMOTI, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD. ( 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GIMOTI FDA Label Details
Indications & Usage
FDA Label (PDF)GIMOTI is indicated for the treatment of Diabetic Gastroparesis.
WARNING: TARDIVE DYSKINESIA Metoclopramide, including GIMOTI, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including GIMOTI, the risk of developing TD increases with duration of treatment and total cumulative dosage...
GIMOTI Patents & Exclusivity
Patents (7 active)
Pro Intelligence Preview
Deep insights for GIMOTI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 7 active patents
Trial Analysis
- • 53 total trials
- • Stage: Mature
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment