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The FDAs response assessment: corrective actions found deficient The firm submitted two responses to the Form FDA 483 and initiated a voluntary recall of all drug products within expiry that had OOS results
This is problematic for two reasons
CJC-1295: Head-to-Head Comparison | Feature | Sermorelin | CJC-1295 (no DAC) | CJC-1295 (with DAC) | |---|---|---|---| | Amino acid length | 29 | 29 (modified) | 29 (modified + albumin-binding) | | Half-life | ~10-20 min | ~30 min | ~6-8 days | | GH release pattern | Pulsatile | Pulsatile | Sustained (blunted pulsatility) | | FDA approval | Withdrawn 2008 | Never approved | Never approved | | Injection frequency | Daily (bedtime) | 1-3x daily | Once weekly | | IGF-1 rise (trial data) | ~30% (Corpas et al.) | Not isolated in RCT | ~2-10x GH (Jett et al.) | | Evidence level | Small RCT | Pharmacokinetic data | Phase II PK study | Frequently Asked Questions Frequently asked questions Can you combine Sermorelin and CJC-1295
The same covalent mechanism of action was previously demonstrated for another PAM of GLP-1R (i.e., BETP), showing that in addition to C347, BETP also formed a covalent adduct with C438 in the C terminus 27 that is invisible in the current GLP-1R complex structures
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