Emideltide (DSIP)
Also sold as: DSIP, Delta Sleep-Inducing Peptide, Delta Sleeping Inducing Peptide, Emideltide acetate, Emideltide (free base)
Emideltide (DSIP) is not FDA-approved, is not a registered drug in any country FDA searched, and appears nowhere on FDA's 503A bulks list — so it may not lawfully be used in 503A compounding for any use. FDA identified studies that administered emideltide intravenously to 209 subjects and found 'insufficient evidence concerning effectiveness' for chronic insomnia, narcolepsy and opioid withdrawal, the three uses it evaluated; for the subcutaneous route emideltide was nominated for, FDA identified no clinical studies of any kind.
Which molecule this is. 'Emideltide' is the INN; the briefing document states verbatim: 'Emideltide is also referred to as Delta Sleeping Inducing Peptide (DSIP).' Nearly all consumer-facing material uses DSIP. Reported to be a nonapeptide. FDA evaluates two related substances — emideltide (free base) and emideltide acetate — because the nominators gave inconsistent information and it is unclear which they intended to nominate. Neither has a USP or NF monograph, and neither is a component of an FDA-approved drug. ROUTE IS THE DECISIVE VARIABLE, not molecule: every human study FDA identified administered emideltide INTRAVENOUSLY. The nominated route — the route compounded products were PROPOSED for — is SUBCUTANEOUS, at 1000 mcg/mL. FDA found no clinical studies of any kind for the SC route. Human data on one route is not human data on another. FDA describes the products it found on sale as 'injection and intranasal' without stating the injectables are subcutaneous.
The FDA advisory committee vote, 24 July 2026
The Pharmacy Compounding Advisory Committee voted against recommending this substance for the 503A bulks list (6-7, one abstention), agreeing with FDA’s staff — the only one of the seven where it did.
It is still not on the list. An advisory committee makes recommendations; it does not change what is permitted. We checked the 503A bulks list on 29 July 2026 and it is still dated 14 May 2026, with this substance absent from it. Adding a substance requires separate FDA action, which has not happened.
Vote tally reported by ABC News and other outlets; FDA had not published minutes or a transcript as of 29 July 2026, so there is no primary document for the tally yet. We will replace it with FDA’s own record when it publishes. The bulks-list status is from the primary document.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
“The nominations were withdrawn, and FDA is evaluating the substances at its discretion.”Checked against the source on .
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
The WITHDRAWAL is established by the briefing document quoted above, not by the bulks list. That distinction is load-bearing: absence from the 503A list shows only that a substance is in none of the three categories. It cannot by itself tell withdrawn-from-nomination apart from never-nominated, or from an approved drug that was never on the nomination track at all. This record cites the document that names the withdrawal. Two nominations were filed — Wells Pharmacy Network (FDA-2015-N-3534-0287) and LDT Health Solutions, Inc. (FDA-2018-N-2973-0002) — and the briefing document's footnote 3 records both as withdrawn (FDA-2015-N-3534-0484 and -0485). One detail cuts specifically against the 'nomination withdrawn, so FDA dropped it' reading: FDA did not drop it. It is 'evaluating the substances at its discretion', and it still considered the withdrawn nominators' own submitted information as part of that evaluation. The withdrawal removed the sponsor, not the scrutiny.
“The nominations were withdrawn, and FDA is evaluating the substances at its discretion.”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
ADMINISTRATION CHECK: passed, and this is the rare record where it passes. FDA's briefing document states directly that it identified studies which ADMINISTERED IV emideltide to humans — 209 subjects, 25-150 nmol/kg, 1 to 15 days. This is not the MOTS-c/TB-500 pattern of endogenous peptide measured as a biomarker; the drug was given to people. Provenance caveat, stated plainly: the administration finding is verified against FDA's evaluation of the underlying literature, which is a primary regulatory source that summarises each study's design and route; we did not independently open Schneider-Helmert and Schoenenberger 1981, Bes 1992 or Schneider-Helmert 1987. WHY 'PROMISING' IS THE CEILING AND NOT AN ENDORSEMENT — the human trials are small, from the 1980s-90s, and contradict each other. In a 1981 randomised, double-blind, placebo-controlled crossover study of six middle-aged subjects with chronic insomnia, researchers reported 'tendencies toward a lower NOA and a higher total SE', with no effect on sleep onset latency or final waking times. Limitations: n=6, intra-subject comparison on sequential nights, results reported as p values without numerical data for placebo, and possible carryover — the same group reported delayed effects 13-22 hours after administration. In a 1992 double-blind placebo-controlled study of 16 subjects with chronic insomnia, researchers reported that short-term IV treatment 'had little therapeutic benefit'; no significant difference in objective sleep measures or subjective sleep quality versus placebo. In Schneider-Helmert 1987, a study of 14 middle-aged subjects with chronic insomnia, researchers reported improved sleep induction and maintenance — but FDA re-classified its design: the authors called it 'placebo-controlled' when 'there was no placebo arm in the study', comparison being against an external matched control group of healthy subjects. FDA read that design as 'externally matched controlled'. (Monti 1987 is a DIFFERENT 1987 study and is not the one with the design problem: FDA describes it as an 'R, DB, PC, CO study' in six subjects with severe chronic insomnia over nine nights, and it did have a placebo arm.) FDA's overall conclusion: 'there is insufficient evidence concerning effectiveness to support the use of emideltide (free base) or emideltide acetate via the IV ROA for the treatment of chronic insomnia, narcolepsy, and opioid withdrawal. Clinical studies for chronic insomnia appear to be inconclusive and at best preliminary.' Note what the tier does NOT transfer to: the trials above are all INTRAVENOUS. For the proposed subcutaneous route, the human evidence base is empty, not thin. No ClinicalTrials.gov registration is cited here — FDA searched that registry itself as part of this evaluation, which is a better source than a self-reported registration.
“We identified several studies that administered IV emideltide to humans. For the list of references and details of the studies refer to Appendix 6. Based on these clinical studies, doses of emideltide between 25 – 150 nmol/kg have been administered intravenously to 209 subjects for 1 to 15 days.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
Emideltide appears nowhere on the 503A bulks list — not in Category 1, 2 or 3 — in the list updated 2026-05-14. It therefore may not lawfully be used in 503A compounding for any use.
Verified by fetching and text-extracting the document directly and searching it for 'emideltide', 'DSIP' and 'delta sleep': zero hits. Read this for exactly what it says and nothing more. The non-compoundability follows from ABSENCE FROM THE LIST itself — a substance not on the list may not be used in 503A compounding, full stop. It does not follow from the scope of FDA's evaluation, and the absence is not a safety finding, not a green light, and not evidence about the molecule either way. Category 2 contains exactly six substances: Cesium Chloride, Domperidone, Germanium Sesquioxide, Ibutamoren Mesylate, Kisspeptin-10, and Quinacrine Hydrochloride for intrauterine administration. Emideltide is not among them — but note that Category 2 is not free of consumer peptides: Kisspeptin-10 is a peptide, and ibutamoren (MK-677) is sold throughout this same market.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .FDA staff propose not adding emideltide (free base) or emideltide acetate to the 503A Bulks List, ahead of the Pharmacy Compounding Advisory Committee meeting on 23-24 July 2026.
A staff proposal is not a final determination. The briefing document states: 'The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.' The stated grounds are three, not one: 'lack of data related to physiochemical characterization, lack of evidence of effectiveness and insufficient safety information'.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding emideltide (free base) or emideltide acetate to the 503A Bulks List.”
Checked against the source on .FDA evaluated emideltide for THREE uses — opioid withdrawal, chronic insomnia and narcolepsy — and declined to evaluate 'paradoxical sleep disorder' because the nominations did not include sufficient information.
The sleep framing that dominates consumer material understates the scope of what FDA looked at. Emideltide was nominated for 'insomnia'; FDA narrowed to 'chronic insomnia' because that was the condition discussed in the nominators' own submitted references. As with BPC-157, the declined use is an EVIDENTIARY VACUUM RATHER THAN AN OPEN QUESTION: FDA did not skip paradoxical sleep disorder because it sits outside FDA's remit, but because the nominations 'did not include sufficient information for the Agency' to evaluate it. That cuts against the sleep-market claims, not for them. Separately, and regardless of which uses were evaluated: emideltide is not on the 503A bulks list, so it may not lawfully be used in 503A compounding for ANY use — including the one FDA never assessed. That follows from its absence from the list itself, not from the scope of FDA's evaluation.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .FDA identified no clinical studies whatsoever — effectiveness or safety — for the nominated subcutaneous route, the route in which compounded products were proposed at 1000 mcg/mL.
This is the finding most likely to be laundered by omission. Human IV data exists and is genuine; it says nothing about the subcutaneous product. FDA also flagged that it is 'unclear how it would be possible to formulate the proposed injectable dosage form with concentration of 1,000 mcg/ml without co-solvent used', given limited water solubility — a formulation objection on top of the evidentiary one.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Clinical studies were not identified that had information for emideltide (free base) or emideltide acetate for the proposed SC ROA.”
Checked against the source on .FDA found the published literature 'too limited to inform the historical use of any form of emideltide compounded drug' products.
Relevant to the common 'it has decades of use behind it' claim. Decades of published IV research in a laboratory setting is not a record of compounded use.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .Emideltide (free base) and emideltide acetate are not registered drugs in ANY country FDA searched, and no form of emideltide is recognised in the European, Japanese or International Pharmacopoeia.
This closes the 'approved somewhere else' escape hatch, which is the standard fallback once the US position is conceded. The briefing document states verbatim: 'No form of emideltide is recognized in the European Pharmacopoeia (11th Edition, 11.8), the Japanese Pharmacopoeia (18th Edition), or the International Pharmacopoeia (11th Edition).' It further records: 'There is no applicable United States Pharmacopeia (USP) or National Formulary (NF) drug substance monograph for emideltide (free base) or its acetate form, and neither is a component of an FDA-approved drug.' Note what this is NOT: a finding about the molecule. Non-registration is a statement about the regulatory record, not about pharmacology.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Emideltide (free base) and emideltide acetate are not registered drugs in any country searched via GlobalEdge.”
Checked against the source on .An online search by FDA did not identify ANY compounding pharmacies marketing emideltide-related compounded preparations — yet emideltide injection and intranasal products are available in the US through integrative neurology clinics, medical concierge services, medical spas, wellness clinics and online retailers.
The two halves of this finding are both FDA's, and the gap between them is the whole market. FDA found the substance widely available and simultaneously could not find a compounding pharmacy openly marketing it — and stated it is 'unclear whether these products are compounded or if pharmacies are currently compounding products containing emideltide-related BDS.' AVAILABILITY IS NOT LEGALITY. That a med spa will sell it establishes nothing about lawful status; emideltide is absent from the 503A bulks list either way. FDA did find that emideltide-related substances 'have been used in compounding since at least 2018' and 'have been studied for use in humans since at least 1981' — so the historical-use question is genuinely mixed, and this record should not flatten it. FDA's conclusion was that the literature is nonetheless too limited to inform that use.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“An online search did not identify any compounding pharmacies marketing emideltide-related compounded preparations.”
Checked against the source on .The nominators' stated reason for compounding emideltide was that there is 'no FDA-approved product available' — a justification FDA rejected in the same document, finding that approved drugs exist for all three conditions evaluated.
The nomination package reproduced in the briefing document answers the question 'What is the reason for use of a compounded drug product rather than an FDA-approved product?' with: 'no FDA-approved product available'. FDA's own conclusion contradicts it directly, and the existence of approved alternatives is load-bearing in FDA's reasoning rather than incidental. Note that FDA's sentence has a compound subject — the approved drugs are one of two limbs, not the sole grounds: 'The lack of data discussed above, and the existence of FDA-approved drugs to treat chronic insomnia, narcolepsy, and opioid withdrawal, particularly considering these are serious and/or life-threatening conditions, weighs against emideltide-related BDSs being added to the 503A Bulks List.' For opioid withdrawal specifically FDA is blunter still: 'There are FDA approved therapies with established efficacy for opioid withdrawal.' The nominator's premise was false, and the falsity of it counted against the nomination.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“At the time of this evaluation, there are FDA-approved drugs for treating serious conditions like insomnia, narcolepsy, and opioid withdrawal in adults.”
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Documented safety signals
A FAERS search for adverse events for emideltide through 3 March 2024 retrieved ZERO reports, and FDA identified no relevant case reports in the medical literature.
Zero FAERS reports is an ABSENCE OF DATA, NOT A FINDING OF SAFETY, and the difference is the whole point. FAERS is a passive, voluntary system; substances bought as research chemicals and self-administered outside clinical care generate few reports by construction, because there is usually no clinician in the loop to file one. FDA drew no safety conclusion from the zero and still proposed not adding the substance, citing 'insufficient safety information'. Anyone citing the zero as a clean safety record has inverted it.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The Office of Surveillance and Epidemiology conducted a search of the FAERS database for reports of adverse events (AEs) for emideltide through March 3, 2024. The search retrieved zero reports.”
Checked against the source on .In a 1984 study of IV emideltide in 107 subjects with alcohol or opiate withdrawal syndrome, three subjects experienced serious adverse effects: two had hypotension at the beginning of the first injection, and one had repetitive episodes of general discomfort with perspiration and nausea lasting 15 minutes. One of those three subjects, who received a second injection, experienced 'progressive hypotension'. Nine subjects had minor transient side effects including perspiration, headaches, nausea and vertigo.
The only serious adverse events in the human record come from the withdrawal population, not the insomnia population — and FDA carried them into its summary conclusion, noting 'cases of hypotension that was "progressive" following second emideltide injection administered IV'. There was no additional information for the subject with progressive hypotension.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .IV emideltide in small numbers of subjects with chronic insomnia was reported well tolerated and not associated with significant adverse events.
Recorded because the record should not be shaded in either direction. Scope limits: 'small numbers of subjects', intravenous, short-term (1 to 15 days across the whole literature), and no data on long-term administration. FDA nonetheless concluded that safety 'is insufficiently characterized'.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .The substances are not well characterised physically and chemically; endotoxin testing for the injectable route is lacking, and FDA identified no information addressing potential aggregation and immunogenicity risks.
No bioburden or endotoxin test is mentioned in the certificate of analysis provided by the nominator. Endotoxin testing is a critical quality attribute for a bulk drug substance intended for injection. This is a manufacturing-quality gap that is independent of whether the molecule works: an effectiveness verdict, favourable or not, would not close it. FDA lists it first among its three stated grounds — 'lack of data related to physiochemical characterization' — ahead of both the effectiveness and the safety grounds.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .FDA flagged that emideltide's stimulation of the opioid system 'could lead to development of addiction', and identified no nonclinical studies addressing that potential.
Almost entirely absent from consumer material, which frames emideltide as a benign sleep peptide. The mechanism cuts both ways in FDA's own telling: the briefing document notes emideltide 'does not appear to interact directly with opioid receptors' but 'can stimulate calcium-dependent release of endorphins', and that this opioid-system stimulation 'could potentially be beneficial to suppress signs and symptoms of alcohol and opioid withdrawal syndromes'. The same mechanism proposed as the therapeutic rationale is the one FDA names as an addiction concern. Read the finding precisely: FDA identified a THEORETICAL risk and an ABSENCE OF STUDIES, not a documented case of dependence. That is not reassurance — an unstudied risk is unquantified, not absent.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“However, stimulation of the opioid system by emideltide-related BDSs could lead to development of addiction, and, at the time of this evaluation, FDA did not identify nonclinical studies to inform the potential addictive potential of emideltide-related BDSs.”
Checked against the source on .No nonclinical toxicity studies exist: the nominator submitted none and FDA identified none, including no developmental or reproductive toxicity studies.
The foundation the human IV data does not sit on. Ordinary drug development runs animal toxicology BEFORE human exposure; here the 1980s human trials exist and the toxicology underneath them does not. FDA separately records that it 'did not identify nonclinical developmental and reproductive studies' of either substance. On carcinogenicity, FDA rejected the one favourable nominator-submitted result as uninterpretable: findings that Deltaran (a product containing emideltide free base AND glycine) reduced chromosome aberrations and spontaneous malignant tumour incidence in female SHR mice 'could not be interpreted as evidence that emideltide-related BDSs have no potential to trigger genotoxicity or carcinogenicity in part because glycine has been reported to have antimutagenic and anticarcinogenic properties'. The confound is that the co-formulated ingredient could account for the effect — so the study cannot clear the peptide.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“At the time of this evaluation, the nominator did not submit, and FDA did not identify nonclinical toxicity studies to inform safety considerations for potential clinical uses of emideltide (free base) or emideltide acetate.”
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Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is DSIP legal in 2026?
Emideltide (DSIP) appears nowhere on FDA's 503A bulks list — not in Category 1, 2 or 3 — on the list updated 14 May 2026, and a substance absent from that list may not lawfully be used in 503A compounding for any indication. Absence from the list is not a safety finding and not a green light; it means emideltide has no lawful route into a 503A compounded preparation, and says nothing either way about the molecule.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Did DSIP become legal again when the nominations were withdrawn?
No. The two nominations to add emideltide (DSIP) to FDA's 503A bulks list were withdrawn, but FDA's briefing document for the July 2026 Pharmacy Compounding Advisory Committee meeting states that FDA 'is evaluating the substances at its discretion' and that it considered the withdrawn nominators' own submitted information as part of that evaluation. The withdrawal removed the sponsor, not the scrutiny: emideltide remains absent from the 503A bulks list, so it still may not lawfully be used in 503A compounding. Withdrawal moved its status sideways, not toward legality.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nominations were withdrawn, and FDA is evaluating the substances at its discretion.”
Checked against the source on .- Did FDA approve DSIP?
No. Emideltide (DSIP) has no FDA approval, and FDA's July 2026 briefing document states that 'Emideltide (free base) and emideltide acetate are not registered drugs in any country searched via GlobalEdge.' No form of emideltide is recognised in the European, Japanese or International Pharmacopoeia, there is no applicable USP or NF drug substance monograph for either form, and neither is a component of an FDA-approved drug.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Emideltide (free base) and emideltide acetate are not registered drugs in any country searched via GlobalEdge.”
Checked against the source on .- Is there any human evidence that DSIP works for sleep?
There is real human data on emideltide (DSIP), and FDA judged it insufficient. FDA's July 2026 briefing document states it identified studies that administered emideltide intravenously to 209 subjects, and concluded: 'Based on available clinical data, there is insufficient evidence concerning effectiveness to support the use of emideltide (free base) or emideltide acetate via the IV ROA for the treatment of chronic insomnia, narcolepsy, and opioid withdrawal. Clinical studies for chronic insomnia appear to be inconclusive and at best preliminary.' FDA noted the studies that showed a positive response 'had poor study methodologies'. Every one of those trials was intravenous; for the subcutaneous route DSIP was nominated for, FDA identified no clinical studies at all.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Based on available clinical data, there is insufficient evidence concerning effectiveness to support the use of emideltide (free base) or emideltide acetate via the IV ROA for the treatment of chronic insomnia, narcolepsy, and opioid withdrawal. Clinical studies for chronic insomnia appear to be inconclusive and at best preliminary.”
Checked against the source on .- Can I get DSIP from a compounding pharmacy?
There is no lawful route: emideltide (DSIP) is absent from FDA's 503A bulks list, so it may not lawfully be used in 503A compounding for any use. FDA's July 2026 briefing document reports that 'An online search did not identify any compounding pharmacies marketing emideltide-related compounded preparations' — while also recording that emideltide injection and intranasal products are available in the US through integrative neurology clinics, medical concierge services, medical spas, wellness clinics and online retailers. That a clinic will sell it establishes nothing about its lawful status.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“An online search did not identify any compounding pharmacies marketing emideltide-related compounded preparations.”
Checked against the source on .- Is DSIP safe?
Emideltide (DSIP) safety is, in FDA's own words, 'insufficiently characterized'. A FAERS search for adverse events through 3 March 2024 retrieved zero reports — an absence of data, not a finding of safety, since FAERS is passive and voluntary. FDA identified no nonclinical toxicity studies of either emideltide form, no developmental or reproductive toxicity studies, and no clinical safety data for the subcutaneous route. In a 1984 study of intravenous emideltide in 107 subjects with alcohol or opiate withdrawal, three subjects experienced serious adverse effects: two had hypotension at the beginning of the first injection, and a third had repetitive episodes of general discomfort with perspiration and nausea lasting 15 minutes. One of those three, after a second injection, experienced what FDA quoted as 'progressive hypotension'. FDA also flagged that emideltide's stimulation of the opioid system 'could lead to development of addiction' and that no nonclinical studies address it.
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Considering that the context of use may be for chronic intermittent use, safety for emideltide-related products is insufficiently characterized.”
Checked against the source on .- What did FDA propose at the July 2026 PCAC meeting about DSIP?
FDA staff proposed NOT adding it. The FDA briefing document for the Pharmacy Compounding Advisory Committee meeting on 23-24 July 2026 states: 'Accordingly, we propose not adding emideltide (free base) or emideltide acetate to the 503A Bulks List.' The stated grounds are three — 'lack of data related to physiochemical characterization, lack of evidence of effectiveness and insufficient safety information'. A staff proposal is not a final determination: the same document states FDA 'will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.'
Emideltide (DSIP)-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding emideltide (free base) or emideltide acetate to the 503A Bulks List.”
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