FDA Peptide Tracker
DSIP (Emideltide): live FDA regulatory status
Sleep-regulating peptide · RFK-14
The two signals
Plain-English verdict: amber.
Regulatory status: PCAC declined · not on Bulks List path.
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
No near-term FDA pathway
Regulatory timeline
- 2023-09 — Category 2 designation
- 2026-04 — Nominations withdrawn — FDA website table update, not a rulemaking
- 2026-07 — PCAC declined inclusion
DSIP (Emideltide): common questions
- Is DSIP legal in 2026?
- No. On July 24, 2026 the PCAC voted to recommend AGAINST adding Emideltide, also known as DSIP, to the 503A Bulks List. The tally is reported as 6–7–1; the FDA has posted no minutes, transcript or vote-results summary for this meeting, so every tally on this site is as reported by trade press. It was the meeting's only rejection. DSIP is not on a Bulks List path and cannot be legitimately compounded.
- Can I get DSIP right now?
- No. DSIP is education-only at Peptós.LIFE. That was true before the vote and it is true after it. Compounded medications are prepared for an individual patient and are not FDA-approved.
- Why was DSIP rejected when six other peptides were recommended?
- FDA's briefing found the evidence did not support effectiveness for the serious conditions proposed, and panelists raised a mechanistic concern: DSIP stimulates endorphin release, which several compared to the reward-pathway activity of addictive drugs. DSIP has the longest human research record of the seven reviewed, which is what made the rejection the meeting's biggest surprise.
- Did DSIP's status get worse after the vote?
- Our regulatory status changed to "PCAC declined · not on Bulks List path." The plain-English verdict did not move — a committee vote does not change it in either direction, because DSIP was not available before the vote and is not available after it.
- What happens next for DSIP?
- There is no near-term FDA pathway. Absent new evidence and a fresh review, nothing is scheduled.
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.
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Last updated July 26, 2026 · Peptós.LIFE · Not medical advice.