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Pipeline

Committed to the Discovery, Development, and Commercialization of Potentially Transformational Therapies

Amylin continues to expand opportunities for its commercialized products, and focus on innovative new therapies for diabetes and metabolic disease. These are investigational products and are not approved by the U.S. Food and Drug Administration (FDA).

Diabetes

  • Amylin is developing exenatide suspension formulations that do not need reconstitution.  A once-weekly and a once-monthly exenatide suspension are in clinical development for the treatment of type 2 diabetes.
  • Metreleptin, an analog of the human hormone leptin, is a unique potential therapy for certain metabolic disorders in patients with rare forms of inherited or acquired lipodystrophy. Lipodystrophy is an “ultra-orphan” rare disease estimated to affect a few thousand people around the world, often with an early age of onset, for which there is a significant unmet medical need. There are currently no approved drugs that treat the underlying cause of the disease.

    People with lipodystrophy lack the required fat tissue for normal metabolic function. As a result, fat accumulates in the blood and organs such as liver and muscle, which can lead to life-threatening complications including insulin-resistant diabetes, hypertriglyceridemia (high levels of triglycerides in the bloodstream), acute pancreatitis, and hepatic steatosis or steatohepatitis, also known as fatty liver disease.

    Metreleptin is being studied as a potential therapy for certain metabolic disorders in patients with inherited or acquired lipodystrophy. Metreleptin is believed to work by reducing fat accumulation in organs, thereby improving insulin sensitivity. Clinical studies have been conducted by investigators at the National Institutes of Health (NIH) and other academic institutions in the US, Europe, and Japan to determine whether metreleptin can improve glycemic control and hypertriglyceridemia in patients with lipodystrophy.

    In April 2012, Amylin completed its Biologics License Application (BLA) for metreleptin to treat diabetes and/or hypertriglyceridemia in patients with rare inherited or acquired forms of lipodystrophy. Amylin also requested Priority Review by the FDA.
  • AC165198 is a peptide hybrid (fusion of two different peptide hormones, within a single molecular entity with dual pharmacology) that is moving to clinical development for the potential treatment of diabetes.

Obesity

Amylin has a worldwide agreement with Takeda Pharmaceutical Company Limited to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.

Additional R&D efforts, in collaboration with specialty research firms, are focused on long-term opportunities in diabetes, obesity and other metabolic diseases.