Abstract
A major ongoing challenge for the biopharmaceutical industry is the clinical development of members of the growth hormone (GH) axis for treatment of age-related diseases. Specific areas of complexity include selection of appropriate doses, using meaningful surrogate markers, and establishing the duration of therapy. Evaluation of the GH axis in disease suggests that each of the component members—GH, growth hormone–releasing hormone (GHRH), growth hormone–releasing peptides (GRP), and insulin-like growth factor–1 (IGF-1)—may offer unique benefits in specific disease states. However, there are few comparative clinical studies differentiating each component. Finally, the long-term safety of growth hormone, GHRH, GRP, and IGF-1 has not yet been established. Thus, while the future looks promising, the journey toward broader use via registered indications will require well-controlled trials that assure confidence in both efficacy and safety.
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