AMITIZA (lubiprostone)
Amitiza helps adults struggling with long-term constipation of unknown origin or constipation caused by chronic opioid use for non-cancer pain. It is also used for women aged 18 and older who have irritable bowel syndrome with constipation. This medication is prescribed to improve bowel motility and ease the passage of stool, though it has not been proven effective for patients using certain opioids like methadone.
How AMITIZA Works
This medication works by specifically activating chloride channels located on the lining of the intestine, which triggers the secretion of chloride-rich fluid into the bowel. This increase in fluid helps stimulate movement within the gut and facilitates the passage of stool. By targeting these specific channels, the drug can bypass the normal ways that opioids block intestinal secretions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2006-01-31
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- CAPSULE
AMITIZA Approval History
What AMITIZA Treats
3 indicationsAMITIZA is approved for 3 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Idiopathic Constipation
- Opioid-Induced Constipation
- Irritable Bowel Syndrome
AMITIZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to AMITIZA
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07277907 STOPS 03 | LB20250919 82370547 | Ph 3 | recruiting | Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation |
| NCT01839734 LAMBCHOP results posted | 13-071 | Ph 2 | completed | Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy |
| NCT00908076 AMITIZA results posted | H-21192 | Ph 4 | completed | Amitiza in Constipation Associated With PD (Parkinson's Disease) |
| NCT01096290 results posted | 09-250 | Ph 4 | terminated | Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications |
| NCT00746395 results posted | 07-096 | Ph 4 | completed | Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy |
| NCT02481947 results posted | BLI400-301 | Ph 3 | completed | A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults |
| NCT02042183 results posted | SAG/0211PFC-1131 2013-004384-31, EMEA-000245-PIP01-08 | Ph 3 | completed | Lubiprostone in Children With Functional Constipation |
| NCT02766777 results posted | SCMP-0211-303 | Ph 3 | completed | Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation |
| NCT01298219 results posted | OBD1033 | Ph 3 | completed | Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL) |
| NCT02138136 results posted | SAG-0211PFC-11S1 2013-004384-31 | Ph 3 | completed | Lubiprostone for Children With Constipation |
| NCT03097861 results posted | SCMP-0211-302 | Ph 3 | completed | Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo |
| NCT02544152 results posted | SCMP-0211-201 | Ph 2 | terminated | Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome |
| NCT01993875 results posted | SCMP-0211-301 | Ph 3 | completed | Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation |
| NCT02729909 results posted | Lubiprostone-3003 U1111-1168-6358, 153300410A0196 | Ph 3 | completed | Lubiprostone for Chronic Idiopathic Constipation Treatment |
| NCT01190020 results posted | MS-LUB-106 | Ph 1 | completed | Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation. |
| NCT02695719 results posted | Lubiprostone-3002 U1111-1168-6272 | Ph 3 | completed | Lubiprostone for Treatment of Chronic Idiopathic Constipation |
| NCT02651155 results posted | Lubiprostone-3001 U1111-1170-0417 | Ph 3 | completed | Lubiprostone for the Treatment of Chronic Idiopathic Constipation |
| NCT00844831 results posted | 285.09 | Ph 4 | completed | Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit |
| NCT01469819 results posted | LUB-119 | Ph 2, Ph 3 | completed | Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation |
| NCT01447849 results posted | MSA-LUB-125 MSA-NC-LUB-125 | Ph 2, Ph 3 | completed | Lubiprostone and Mucus Secretion in Patients With Chronic Constipation |
| NCT01170039 results posted | IRB00014592 | Ph 4 | completed | The Effectiveness of Lubiprostone in Constipated Diabetics |
| NCT01236534 results posted | URMC08-022LUB | Ph 4 | completed | Lubiprostone in Patients With Multiple Sclerosis Associated Constipation |
| NCT01674530 | DRL-USG01-L/2012 | Ph 3 | completed | Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation |
| NCT00934479 | 09-001281 | Ph 1 | completed | Intestinal Microecology in Chronic Constipation |
| NCT01324284 Lubiprostone | AIG-GI2011-01 | Ph 3 | completed | Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy |
| NCT01372423 | CS-01-2011 71060001 | Ph 3 | completed | Evaluation of Clinical Equivalence Between Two Lubiprostone Products |
| NCT01166789 | 07-004L | Ph 1 | completed | Lubiprostone Effects on Visceral Pain Sensitivity |
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.
AMITIZA FDA Label Details
Indications & Usage
FDA Label (PDF)AMITIZA is indicated for the treatment of Chronic Idiopathic Constipation; Opioid-Induced Constipation; Irritable Bowel Syndrome.
Pro Intelligence Preview
Deep insights for AMITIZA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 12 active patents
Trial Analysis
- • 28 total trials
- • Stage: Declining
Competitive Landscape
- • 13 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