AOD-9604

FDA describes AOD-9604 as a modified growth-hormone fragment with an added tyrosine. A product labeled only “HGH fragment 176–191” cannot be assumed to match the chemically characterized AOD-9604 preparation or inherit its clinical evidence.^[1]

• This is an applicability limitation: shorthand product names alone cannot establish molecular equivalence.
• The source document itself is not fully internally consistent about the tyrosine's location: pp. 7 and 11 both state 'N-terminal end' while a pharmacology section on p. 28 states 'C-terminal'. This claim follows the twice-repeated pp. 7/11 wording; the discrepancy is preserved here rather than silently resolved. See peptide-hgh-fragment-176-191-identity-1 for independent analytical confirmation that AOD-9604 and hGH fragment 176-191 are treated as distinct, separately detectable molecules.

FDA reviews describe limited clinical safety information for AOD-9604. In oral-route human reports, serious adverse events included diarrhea, chest tightness and various cancers, with insufficient information to assess relatedness; intravenous-route reports described chest tightness and euphoria as possibly related. A separate FDA compounding-safety listing also states that serious adverse events may be associated with AOD-9604, though causality is not clear. No human data on the proposed subcutaneous or transdermal routes were identified.^[1][2]

• FDA explicitly states there was insufficient information to assess whether these adverse events, particularly the reported cancers, were related to AOD-9604; this is not a demonstrated causal safety signal.
• Both sources are FDA analyses rather than independent bodies, so they do not constitute independent corroboration of each other, only two distinct agency documents describing overlapping concerns.
• The AOD-9604 briefing is a pre-decisional PCAC document; no final FDA safety determination for AOD-9604 was located within this pass's searches.

FDA’s review found insufficient evidence for AOD-9604 as an obesity treatment. Sponsor-reported results from a larger oral trial did not show a weight-loss advantage over placebo; those oral data do not validate proposed subcutaneous products.^[1]

• Full trial reporting was limited, and lack of demonstrated benefit is not proof of harm.
• This conclusion appears in a pre-decisional PCAC briefing memorandum (dated 2024-11-05 for a 2024-12-04 advisory-committee meeting); the document itself states FDA had not yet issued a final determination. No later final determination was located within this pass's searches.