La Jolla announces completion of enrollment of Phase 2 study of GCS-100 La Jolla Pharmaceutical announced that it has completed enrollment of GCS-100-CS-4003, its Phase 2 Extension study of GCS-100 in chronic kidney disease. The 4003 study was initiated to study the long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week Phase 2 study. A total of 93 patients enrolled across 5 sites. Initial data from the 4003 Extension study is expected late this year.
News For LJPC From The Last 14 Days
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La Jolla plans initiation of Phase 3 registration program for LJPC-501 for CRH La Jolla Pharmaceutical announced that the company plans to begin a phase 3 registration program for LJPC-501 for the treatment of catecholamine-resistant hypotension, a new indication. Initiation of this registration program is the result of a recent meeting between the company and the FDA at which agreement was reached that blood pressure is an appropriate primary endpoint for approval. Due to the estimated size of the patient population in the United States for this indication, the company has filed for Orphan Drug status for angiotensin II.