PCAC · Voted Friday, July 24, 2026
Emideltide (DSIP) at the compounding committee: not recommended
On July 24, 2026, the committee voted 6–7, with one abstention, against recommending Emideltide (DSIP) for the 503A Bulks List — siding with FDA staff, who had proposed adding neither form. It was the only one of the seven compounds the committee turned down.
FDA staff's position, June 29: FDA proposes not adding either emideltide substance to the 503A Bulks List. This is the one case of the seven where FDA accepts that the substance has a genuine history of compounding use — and still concludes the balance weighs against it, on characterisation, effectiveness and safety.
Published July 16, 2026 · Updated September 25, 2026 · By the Grey Peptides Editorial Board · ✓ Sourced from FDA's briefing document
FDA staff had proposed adding neither form of Emideltide (DSIP), and the committee agreed. Emideltide (DSIP) stays off the 503A Bulks List.
Emideltide was the only one of the seven on which the committee agreed with FDA staff.
| Substances | Emideltide (free base) and emideltide acetate |
| Also known as | Delta sleep-inducing peptide, DSIP |
| Length | 9 amino acids |
| Use FDA reviewed | Opioid withdrawal, chronic insomnia, and narcolepsy |
| Forms proposed | Injectable, proposed at 1,000 µg/mL |
| Nomination | Nominations withdrawn; FDA evaluated at its own discretion |
| FDA staff position | Proposed not adding either form to the 503A Bulks List |
| Committee vote | Not recommended — 6–7, 1 abstention (July 24, 2026) |
What FDA reviewed it for
FDA evaluated all three nominated uses: opioid withdrawal, chronic insomnia, and narcolepsy.
This is not a detail to skip past. FDA evaluates a bulk drug substance in the context of the use proposed for it — so the question in front of the committee was not "is Emideltide (DSIP) useful?" but "does the evidence support compounding Emideltide (DSIP) for opioid withdrawal, chronic insomnia, and narcolepsy?" A substance can have an interesting research literature in a completely different area and still fail this test, because that literature was never the thing under review.
FDA's specific objections
FDA weighs four criteria: whether the substance is well characterised physically and chemically, whether it has been used historically in compounding, what evidence exists on effectiveness, and what safety issues its use in compounding raises. Here is where Emideltide (DSIP) landed on each.
FDA says neither form is well characterised, and specifically notes that endotoxin testing for the injectable route is lacking.
The sharpest technical objection of the seven. Emideltide has limited water solubility, and FDA says it is unclear how the proposed injectable at 1,000 µg/mL could be formulated at all without a co-solvent. The nomination did not explain how.
FDA found no study evaluating effectiveness that would support the use of emideltide, and insufficient evidence to conclude on intravenous emideltide. Where studies did report positive responses, FDA describes the results as difficult to interpret — small numbers, externally controlled designs, imbalanced baseline characteristics and outcomes.
Nonclinical and clinical safety data were lacking, and FDA did not identify information addressing aggregation or immunogenicity risk.
What is specific to Emideltide (DSIP)
Six of the seven objections above could be written about almost any of the compounds on the July agenda. These next points could not — they are what makes this file different from the other six.
FDA states that available data suggests emideltide has been used historically in compounding. On the four-criteria balance, that counts in its favour — and FDA still proposes against it, because the other three criteria weigh the other way. This matters for reading the meeting: historical use alone does not carry a substance onto the list.
FDA notes that the American Academy of Sleep Medicine and American College of Physicians guidelines on chronic insomnia do not discuss emideltide, and neither do the AASM and European narcolepsy guidelines. ACP guidance recommends cognitive behavioural therapy for insomnia as first-line treatment for all adults.
FDA notes approved drugs exist for insomnia, narcolepsy and opioid withdrawal in adults — all three of the nominated uses, all serious conditions.
The evidence picture
Grey Peptides grades DSIP's evidence base as low. Most of the human literature is Eastern European work from the 1980s and 1990s, and the compound was never commercially developed. FDA's characterisation of the effectiveness evidence as small, externally controlled and difficult to interpret is a fair description of that record.
Two readings of the same file are worth separating. FDA's conclusion is about a regulatory question — whether the record supports letting pharmacists compound this substance for this use. That is a higher bar than "there is some interesting science here," and a lower bar than "this substance is harmful." Almost everything FDA said about Emideltide (DSIP) is a statement about missing information, not a finding of harm. Reporting that as "FDA says Emideltide (DSIP) is dangerous" is wrong. So is reporting it as "FDA found no safety problems."
Where this sits in our encyclopedia
Our entry on this compound covers the underlying pharmacology, the published literature, and the status picture independent of this meeting. The two are separate reads: the encyclopedia entry is about the compound, and this page is about the regulatory file.
Mechanism, evidence grade, half-life, approval status, and sources. PCAC July 2026 — the full picture
All seven compounds, what the vote does and doesn't change, and what to watch. Peptide Regulatory Status Tracker
Category 1/2/3, 503A vs 503B, and where every peptide sits.
The other six compounds
BPC-157 · KPV · TB-500 · MOTS-c · Semax · Epitalon
FDA — July 23–24, 2026 Meeting of the Pharmacy Compounding Advisory Committee ↗
FDA briefing documents released June 29, 2026. Federal Register notice 91 FR 20465, published April 16, 2026 (FR Doc. 2026-07361), Docket No. FDA-2025-N-6895. FDA Briefing Document for Emideltide (free base) and emideltide acetate, released June 29, 2026.
- FDA — July 23–24, 2026 PCAC meeting page: briefing documents, roster, presentations, video (last updated Aug 6, 2026)
- FDA — Questions put to the committee (separate free-base and acetate votes)
- FDA — Bulk drug substances nominated under 503A, by category (updated May 14, 2026; read Sept 25, 2026)
- FDA — Next PCAC meeting, before the end of February 2027 (no date set)
- Hyman, Phelps & McNamara, FDA Law Blog — July 24 votes
- McDermott — PCAC backs majority of peptides in two-day public meeting
- RAPS Regulatory Focus — committee backs two more peptides, rejects one (July 24, 2026)
- Fierce Pharma — first-day votes (July 23, 2026)
- Frier Levitt — what the recommendations mean (Sept 17, 2026)
FDA had not posted minutes as of September 25, 2026, so tallies are as reported by the sources above. Published reports agree on every tally except epitalon's. Hyman, Phelps & McNamara's FDA Law Blog and McDermott report 7–4; RAPS reports 7–5; all three give one abstention. FDA has not posted minutes, and we will record the official count when it does. The outcome is not in dispute.