The New Drug Application (NDA) for ITCA 650 in the treatment of type 2 diabetes was submitted to the U.S. Food and Drug Administration on November 20, 2016.

FREEDOM CLINICAL PROGRAM

FREEDOM is a global clinical trial development program made up of four Phase 3 studies collectively designed to assess whether the addition of ITCA 650 (continuous subcutaneous delivery of exenatide) to current standards of care results in superior outcomes and whether ITCA 650 is superior to the leading branded oral therapy for the treatment of type 2 diabetes (T2D). The program enrolled >5,000 subjects at >500 clinical investigation sites in >30 countries to support U.S., EU and other regulatory filings. If approved by regulatory authorities, ITCA 650 could transform the way type 2 diabetes is managed today, as ITCA 650 would be the first and only once or twice yearly, non-injectable GLP-1 therapy.

Our FREEDOM-1, FREEDOM-1 HBL, FREEDOM-2, and FREEDOM-CVO trials are now successfully completed (for results, see Press Release section).


FREEDOM-1 is a U.S.-only, placebo-controlled, double-blind study comparing ITCA 650 doses of 40 mcg/d and 60 mcg/d to placebo. This study has been completed. More


FREEDOM-1 HBL (High Baseline) is an open-label study for patients meeting all the entrance criteria for FREEDOM-1, but with HbA1c levels greater than 10%. This study has been completed. More


FREEDOM-2 is a 500-patient, global, active-comparator controlled, double-blind, double-dummy study in patients on metformin only, comparing ITCA 650 20 mcg/d for 13 weeks plus ITCA 650 60 mcg/d for 39 weeks to patients taking sitagliptin (Januvia®, Merck). This study has been completed. More


FREEDOM-CVO Safety Study is a global, placebo-controlled cardiovascular outcomes study examining the safety of ITCA 650 at 60 mcg/d vs. placebo in approximately 4,000 patients on a variety of approved anti-diabetes therapies. This study has been completed. More


The Science & Technology of Our Pipeline

Our chemistry innovation and stability technology form our platform of pipeline products and the core of our clinical promise. That promise could prove to be game-changing in major diseases and disorders around the world.

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