In the Pipeline
The following table summarizes the development status of AMITIZA® and our key product candidates. We currently hold all of the commercialization rights to the prostone compounds in our product pipeline, other than for commercialization fo AMITIZA in the United States and Canada, which is covered by our collaboration and license agreement with Takeda.
To learn more about a particular indication, please click on its name in the table below.
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Target Indication | Development Phase | Next Milestone | ||||
| AMITIZA® (lubiprostone) | |
Chronic idiopathic constipation (CIC) (adults of all ages) | Marketed in the U.S. | New Drug Submission (NDS) in Canada | ||||
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Approved in Switzerland | Pricing negotiations with Swiss government health agency | ||||||
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| Phase 3 efficacy and safety trials in Japanese patients | Data expected in 2010 | |||||||
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| Irritable bowel syndrome with constipation (adult women) (IBS-C) | Marketed in the U.S. | ― | ||||||
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| Chronic idiopathic constipation (CIC) (pediatric patients with renal impairment and patients with hepatic impairment) | Phase 4 pediatric, renal impairment and hepatic impairment trials completed and submitted to the FDA | ― | ||||||
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| Opioid-induced bowel dysfunction (OBD) | Two phase 3 efficacy trials completed; analysis of results ongoing | Phase 3 safety trial to complete in 2010 and data from all 3 trials to be filed with FDA | ||||||
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| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| Rescula (unoprostone) | |
Dry age-related macular degeneration (dry AMD) |
Preclinical |
Phase 2a trial |
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Glaucoma and ocular hypertension | Approved in the U.S. | Limited commercialization | |||||
| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| Cobiprostone | |
Gastrointestinal |
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Prevention of non-steroidal anti-inflammatory drug (NSAID)- induced ulcers | Phase 2a trial results reported | Phase 2b trial | |||||
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| Pulmonary |
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| Chronic obstructive pulmonary disease (COPD) | Preclinical | Finalize inhaled formulation | ||||||
| Dermatology |
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| Wound Healing | Preclinical | Phase 1 trial | ||||||
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| Product/Product Candidate | |
Target Indication | Development Phase | Next Milestone | ||||
| SPI-017 | |
Peripheral arterial disease (PAD) | Phase 1 human clinical safety studies in Japan | Phase 1 program to complete in 2010 | ||||
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| SPI-3608 | |
Spinal stenosis | Preclinical | Phase 1 trial | ||||
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As of March 25, 2010