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OPN-375
OPN-375 is a selective serotonin 5-HT4 receptor agonist that enhances gastric motility and accelerates gastric emptying.
OPN-375 is a selective serotonin 5-HT4 receptor agonist that enhances gastric motility and accelerates gastric emptying. Used for Gastroparesis (diabetic and idiopathic).
At a glance
| Generic name | OPN-375 |
|---|---|
| Sponsor | Optinose US Inc. |
| Drug class | 5-HT4 receptor agonist |
| Target | 5-HT4 receptor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
By activating 5-HT4 receptors in the gastrointestinal tract, OPN-375 promotes coordinated muscle contractions that propel food through the stomach more efficiently. This mechanism addresses the underlying pathophysiology of gastroparesis, a condition characterized by delayed gastric emptying and associated symptoms such as nausea, vomiting, and early satiety.
Approved indications
- Gastroparesis (diabetic and idiopathic)
Common side effects
- Headache
- Diarrhea
- Nausea
- Abdominal pain
Key clinical trials
- OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps (PHASE3)
- Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps (PHASE3)
- Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps (PHASE3)
- Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis Without the Presence of Nasal Polyps (PHASE3)
- Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video (PHASE3)
- Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety (PHASE3)
- Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device (PHASE3)
- 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OPN-375 CI brief — competitive landscape report
- OPN-375 updates RSS · CI watch RSS
- Optinose US Inc. portfolio CI