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Higher-Molecular-Weight Species Orthogonal methods may be needed because reverse-phase HPLC does not identify every aggregate or peptide complex

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doi: 10.1080/10715762.2018.1455095 70 JinLCaoYZhangTWangPJiDLiuXet al

Several factors explain the lack of approval: insufficient clinical trials (no completed Phase 3 trials for most indications), safety concerns (FDA has identified specific adverse events), commercial considerations (patent status affects development investment), regulatory pathway (approval requires specific, rigorous documentation), and competition (Tesamorelin already approved for related indication)

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