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Amitiza (LUBIPROSTONE)
Amitiza works by activating chloride channels in the intestines, increasing fluid secretion and promoting bowel movements.
Amitiza (Lubiprostone) is a small molecule chloride channel activator developed by Sucampo Pharma LLC, targeting the chloride channel protein 2. It was FDA-approved in 2006 for the treatment of chronic idiopathic constipation and irritable bowel syndrome characterized by constipation. Amitiza is commercially available, with multiple generic manufacturers. Key safety considerations include its potential to cause gastrointestinal side effects. The commercial status of Amitiza is not off-patent.
At a glance
| Generic name | LUBIPROSTONE |
|---|---|
| Sponsor | Sucampo Pharma Llc |
| Drug class | Chloride Channel Activator [EPC] |
| Target | Chloride channel protein 2 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2006 |
Mechanism of action
Lubiprostone is locally acting chloride channel activator that enhances chloride-rich intestinal fluid secretion without altering sodium and potassium concentrations in the serum. Lubiprostone acts by specifically activating ClC-2, which is normal constituent of the apical membrane of the human intestine, in protein kinase A-independent fashion.Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of lubiprostone and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium. Lubiprostone, via activation of apical ClC-2 channels in intestinal epithelial cells, bypasses the antisecretory action of opiates that results from suppression of secretomotor neuron excitability. Activation of ClC-2 by lubiprostone has also been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability via the restoration of tight junction protein compl
Approved indications
- Chronic idiopathic constipation
- Irritable bowel syndrome characterized by constipation
Common side effects
- Nausea
- Diarrhea
- Abdominal pain
- Abdominal distension
- Flatulence
- Vomiting
- Headache
- Loose stools
- Edema
- Abdominal discomfort
- Dizziness
- Chest discomfort/pain
Key clinical trials
- Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer (PHASE2)
- Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation (PHASE3)
- The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation
- Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
- Anorectal Manometery in Pediatric Chronic Refractory Constipation (PHASE1,PHASE2)
- Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease (PHASE3)
- Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy (PHASE2)
- Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amitiza CI brief — competitive landscape report
- Amitiza updates RSS · CI watch RSS
- Sucampo Pharma Llc portfolio CI