FDA Peptide Tracker
Dihexa: live FDA regulatory status
Research-stage cognition peptide · RFK-14
The two signals
Plain-English verdict: amber.
Regulatory status: Under PCAC review, 2nd batch (projected Feb 2027).
These two never collapse into one. Removal from a list is not the same as legal-to-compound, and neither is the same as available.
Availability at Peptós.LIFE
Education only
What happens next
Second PCAC review — By end of Feb 2027
Regulatory timeline
- 2026-07 — Named for second-batch review
- 2027-02 — Second PCAC review — by end of Feb 2027
PCAC is advisory: its Jul 2026 recommendation leads to rulemaking, not instant availability. A favorable advisory vote is a recommendation, not FDA approval or authorization to compound. Realistic earliest legitimate access is late 2026 into 2027. Reclassification is not the same as FDA approval. Compounded medications are not evaluated or approved by the FDA for safety, efficacy, or quality, where that applies, we say so, plainly.
Primary source: FDA source record
See the full status board or this molecule's knowledge-base monograph.
Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.