Verified product status
CJC-1295 and CJC-1295 DAC Regulatory Status
FDA’s December 2024 compounding review proposed that multiple CJC-1295 and CJC-1295 DAC forms not be included on the 503A Bulks List. The naming distinction between DAC and non-DAC materials remains material to identity and evidence interpretation.
Dated verification
What the reviewed sources establish
A regulatory proposal, advisory recommendation, clinical-development stage and marketing approval are kept as separate findings.
No FDA-approved CJC-1295 finished drug identified in the reviewed FDA material
FDA PCAC briefing
FDA proposed not including five specified CJC-1295/CJC-1295 DAC forms
December 4, 2024 briefing document
DAC and non-DAC forms require distinct identity records
Named FDA-evaluated substances and published pharmacology
Status timeline
Keep the date attached to the claim.
Later events do not retroactively change what an earlier source established. This timeline records the source context used for the current wording.
Published human studies evaluated a long-acting CJC-1295 construct; study material and protocol remain source-specific.
FDA presented proposals not to include specified CJC-1295 and DAC forms on the 503A Bulks List.
No later FDA approval is claimed by this tracker.
Entity boundary
The name is not the approval.
A CJC-1295 clinical study or compounding review does not verify the identity of a catalog lot. “With DAC” and “without DAC” should not be treated as interchangeable names.
Research and regulatory information only. No clinical-use or dosing guidance.Primary and technical sources
Records used for this guide
Sources are linked directly so the wording, date and scope can be checked independently.
- 01Source record
December 4, 2024 PCAC Briefing Document
U.S. FDA. CJC-1295-related bulk-substance recommendations.
- 02Source record
Prolonged stimulation of GH and IGF-I secretion by CJC-1295
Teichman SL, et al. J Clin Endocrinol Metab. 2006. PMID 16352683.
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