# DSIP DSIP is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is insufficient: a few small, old studies in people disagree. FDA found too little evidence that it helps any use it reviewed. Status checked: 2026-10-25. Last verified: 2026-10-26. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | Emideltide, Delta sleep-inducing peptide, Emideltide (free base), Emideltide acetate, Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu | primary | 2026-10-25 | [source](https://www.fda.gov/media/193344/download) | | Class | neuro-and-cognitive | primary | 2026-10-25 | [source](https://www.fda.gov/media/193344/download) | | Regulatory status | limbo | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) | | Status source read | 2026-10-23 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) | | Evidence grade | insufficient | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name DSIP Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 ## Summary A chain of nine amino acids, first found in rabbit blood. FDA calls it emideltide. It is in no FDA-approved drug. It is sold for sleep, stress and other uses. Source: https://www.fda.gov/media/193344/download ## Short answer DSIP is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is insufficient: a few small, old studies in people disagree. FDA found too little evidence that it helps any use it reviewed. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - FDA warns that DSIP given as a shot may set off the immune system. Peptides can clump together, which can make this worse [^1] [^6]. - In a study of people in drug or alcohol withdrawal, some had headache, nausea or dizziness. A few had a drop in blood pressure [^6] [^18]. - FDA says DSIP acts on the body's opioid system. That could lead to addiction, and no study has tested this risk [^6]. - FDA treats the free base and the salt form of DSIP as different substances. Websites selling DSIP do not say which form they hold [^6]. - FDA warns that shots made outside drug rules can carry germs or toxins straight into the body. That can cause a life-threatening illness [^9]. Source: https://www.fda.gov/media/193344/download ## What nobody knows yet - No study has tested DSIP shots under the skin, the way it is sold. Every study in people gave it into a vein [^6]. - Studies of DSIP for insomnia disagree. Nobody knows whether it helps sleep in a way a person would notice [^6] [^14] [^16]. - Scientists have never found the gene or the receptor for DSIP. What it does in the body is still unclear [^21]. - No animal study of DSIP alone has tested its harms over months or years. A mouse study of a mixed product cannot rule out a cancer risk [^6]. - FDA did not review DSIP for stress, pain, cancer or brain diseases. Websites and clinics sell it for these uses [^6]. Source: https://www.fda.gov/media/193344/download ## What it is DSIP stands for delta sleep-inducing peptide. FDA calls it emideltide [^5] [^6]. It is a chain of nine amino acids [^6]. Amino acids are the building blocks of proteins. Scientists first took it from rabbit blood in 1977 [^21]. Its name comes from delta waves, brain waves that rise in one kind of sleep [^6]. DSIP is part of no FDA-approved drug and has no official US quality standard [^6]. It comes as a free base and as an acetate salt, and FDA treats them as two different substances [^6]. No country FDA searched has registered it as a drug [^6]. In the US, clinics and websites sell it as shots and nose sprays [^6]. They promote it for sleep, stress, pain, cancer, brain diseases, and drug or alcohol withdrawal [^6]. Source: https://www.fda.gov/media/193344/download ## Where it stands legally DSIP is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. FDA reviewed it for opioid withdrawal, long-term insomnia and narcolepsy, a disorder of sudden sleep [^4] [^5]. Websites and clinics sell it for sleep, stress, pain and other uses [^6]. Checked 23 October 2026. Category 2 is FDA's list of substances that raise significant safety concerns. Category 1 is the list of substances under evaluation, which pharmacies may use while FDA reviews them [^2] [^3]. The groups that nominated DSIP withdrew their nominations, so it came off Category 2 [^1] [^6]. FDA then reviewed both forms on its own [^6]. FDA's scientists found that the evidence weighs against adding either form to the list [^6] [^8]. On 24 July 2026, FDA's Pharmacy Compounding Advisory Committee met on DSIP, under the name emideltide [^4] [^5] [^7]. One legal report says the committee voted 6 to 7, with 1 member abstaining, and did not recommend adding it [^12]. A news report says it was the only peptide the committee voted down [^22]. FDA's meeting page does not show the vote [^5]. A vote against DSIP is still only advice, just as a vote for it would be [^12]. FDA decides by writing a rule, after public comment [^12] [^23]. Until FDA acts, a pharmacy that makes DSIP is outside federal law [^3] [^10]. In 2020, FDA warned a compounder that DSIP was not eligible for compounding [^10]. The same year, that compounding pharmacy pleaded guilty to distributing unapproved new drugs, DSIP among them [^11]. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## What the evidence shows The evidence grade is insufficient: a few small studies in people exist, most from the 1980s, and they disagree [^6]. FDA found too little evidence that DSIP helps any of the three uses it reviewed [^6]. Every study in people gave DSIP into a vein. None tested shots under the skin, the way it is sold [^6]. Insomnia: in a 1992 Amsterdam study, 16 adults with long-term insomnia got DSIP or a placebo, a dummy treatment [^14]. The effects were weak, and the authors said DSIP is not likely to be of major benefit [^14]. In a 1987 study, adults with insomnia got DSIP on some nights and a placebo on others [^15]. The authors found the gain in sleep was of little clinical value [^15]. A third 1987 study, in 14 adults, reported much better sleep and daytime alertness [^16]. FDA notes that this study had no true placebo group, so its results are hard to judge [^6]. Narcolepsy: one 1984 report describes a single man with narcolepsy. He had fewer sleep attacks while taking DSIP [^17]. FDA says one case is too little to judge [^6]. Withdrawal: in a 1984 Geneva study, 107 hospital patients in alcohol or opioid withdrawal got DSIP [^6] [^18]. The authors report that symptoms went away or eased in most of them [^18]. The study had no comparison group, and FDA says its results should be read with caution [^6]. Animals: in rats, DSIP made sleep last longer [^19]. In another rat study, blocking the body's own DSIP stopped a rise in slow-wave sleep after the rats lost sleep [^20]. FDA notes sleep effects in rabbits, cats and rats [^6]. A 2006 review says the link between DSIP and sleep was never clearly shown [^21]. Source: https://www.fda.gov/media/193344/download ## Legitimate ways to get it There is no legal way to get DSIP in the US today [^6]. No approved drug contains it. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. DSIP is neither [^3] [^6]. FDA could still add it by writing a rule, but its committee advised against that [^12]. No country FDA searched has registered DSIP as a drug [^6]. Any open trial that gives DSIP would appear in the trials block below, with the date the official registry was last checked. FDA notes that approved drugs already exist for insomnia, narcolepsy and opioid withdrawal [^6]. Source: https://www.fda.gov/media/193344/download ## How people are getting it anyway This section describes what happens and is not a recommendation. People who use DSIP in the US get it in three main ways [^6]. The first is websites that sell it as shots or nose sprays [^6]. FDA treats products like these as unapproved new drugs when the seller's own words show they are meant for people [^9]. The second is pharmacies. From 2018 to 2020, one compounding pharmacy made and sold products with DSIP, and it later pleaded guilty [^6] [^11]. The third is clinics. Neurology clinics, concierge doctors, medical spas and wellness clinics market DSIP shots and nose sprays [^6]. In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no published tests of DSIP powder for impurities, clumps or germ toxins [^6]. None of the websites FDA searched say which form of DSIP they sell [^6]. FDA's file of harm reports held none for DSIP as of March 2024 [^6]. Source: https://www.fda.gov/media/193344/download ## Access routes Source: https://www.fda.gov/media/193344/download ### None Detail: There is no legal route to DSIP in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use. Source: https://www.fda.gov/media/193344/download ## Unofficial channels Source: https://www.fda.gov/media/193344/download ### Research use seller What it is: Sold by online retailers as shots or nose sprays. Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant to treat a disease or change how the body works. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Documented risks: - FDA warns that injected drugs bypass some of the body's defenses and can carry toxins or germs that cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) - FDA found that none of the websites it searched say which form of DSIP they sell. FDA treats each form as a different substance. (source: https://www.fda.gov/media/193344/download) Enforcement: - 2026-08-24: FDA warning letter to an online seller of peptide shots. The letter did not name DSIP. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### Compounding outside the rules What it is: Made by a pharmacy from bulk DSIP powder. FDA found one pharmacy that made and sold DSIP products from 2018 to 2020. Legal position: DSIP has no official quality standard, is in no approved drug and is not on the federal list, so a pharmacy may not compound it under section 503A. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act) Documented risks: - FDA found no safety data for DSIP given as a shot under the skin, the way it was nominated. (source: https://www.fda.gov/media/193344/download) - FDA found no published tests of DSIP powder for impurities, clumps or germ toxins. (source: https://www.fda.gov/media/193344/download) Enforcement: - 2020-04-01: FDA warning letter to a compounding pharmacy: DSIP was among bulk substances that made its products ineligible under section 503A. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020) - 2020-10-29: US Department of Justice: a Kentucky compounding pharmacy and its owner pleaded guilty to distributing unapproved new drugs, DSIP among them. (source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution) Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### Clinic or med spa What it is: Neurology clinics, concierge doctors, medical spas and wellness clinics that market DSIP shots and nose sprays for sleep, stress and other uses. Legal position: A clinic's prescription does not make DSIP lawful to compound. It is still a substance that is not on the federal list. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act) Documented risks: - FDA has no safety information on DSIP for the proposed route, so it cannot say whether it would cause harm. (source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) - FDA warns that DSIP acts on the body's opioid system, which could lead to addiction. (source: https://www.fda.gov/media/193344/download) Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ## Recruiting trials Snapshot date: 2026-10-25. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. None in this snapshot. Source: https://clinicaltrials.gov/api/v2/studies?query.intr=DSIP+OR+emideltide&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.fda.gov/media/193344/download ### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 2. FDA: categories of bulk drug substances nominated under section 503A, list updated 14 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 3. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting Type: regulatory Tier: primary Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html ### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 ### 6. FDA briefing document on emideltide (DSIP) for the July 2026 committee meeting, 11 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/193344/download ### 7. FDA: questions put to the committee at the July 2026 meeting Type: regulatory Tier: primary Source: https://www.fda.gov/media/193711/download ### 8. FDA: presentations to the committee on 24 July 2026, including emideltide Type: regulatory Tier: primary Source: https://www.fda.gov/media/193774/download ### 9. FDA warning letter to an online seller of peptide shots, 24 August 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### 10. FDA warning letter to a compounding pharmacy, 1 April 2020 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020 ### 11. US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 Type: regulatory Tier: primary Source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution ### 12. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean Type: legal-analysis Tier: legal-analysis Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ ### 13. Goodwin: FDA signals a possible change in its stance on compounding some peptides Type: legal-analysis Tier: legal-analysis Source: https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides ### 14. DSIP and sleep in 16 adults with long-term insomnia, double-blind, Amsterdam, 1992 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/1299794/ ### 15. DSIP against placebo on different nights in adults with insomnia, 1987 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/3583493/ ### 16. DSIP over seven nights in 14 adults with severe insomnia, 1987 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/3622582/ ### 17. DSIP in one man with narcolepsy, 1984 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/6548968/ ### 18. DSIP in hospital patients withdrawing from alcohol or opioids, 1984 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/6548969/ ### 19. DSIP and how long rats sleep, 1979 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/530466/ ### 20. Blocking DSIP and slow-wave sleep after sleep loss in rats, Dallas, 1988 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/3368469/ ### 21. Review: DSIP, a still unresolved riddle, 2006 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/16539679/ ### 22. NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026 Type: reference Tier: established-news Source: https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions ### 23. NBC News: FDA panel recommends easing peptide limits despite agency scientists Type: reference Tier: established-news Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 Last verified: 2026-10-26. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=DSIP+OR+emideltide&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 - https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - https://www.fda.gov/media/193344/download - https://www.fda.gov/media/94155/download [^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^2]: FDA: categories of bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download [^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html [^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 [^6]: FDA briefing document on emideltide (DSIP) for the July 2026 committee meeting, 11 May 2026 https://www.fda.gov/media/193344/download [^7]: FDA: questions put to the committee at the July 2026 meeting https://www.fda.gov/media/193711/download [^8]: FDA: presentations to the committee on 24 July 2026, including emideltide https://www.fda.gov/media/193774/download [^9]: FDA warning letter to an online seller of peptide shots, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 [^10]: FDA warning letter to a compounding pharmacy, 1 April 2020 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020 [^11]: US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution [^12]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ [^14]: DSIP and sleep in 16 adults with long-term insomnia, double-blind, Amsterdam, 1992 https://pubmed.ncbi.nlm.nih.gov/1299794/ [^15]: DSIP against placebo on different nights in adults with insomnia, 1987 https://pubmed.ncbi.nlm.nih.gov/3583493/ [^16]: DSIP over seven nights in 14 adults with severe insomnia, 1987 https://pubmed.ncbi.nlm.nih.gov/3622582/ [^17]: DSIP in one man with narcolepsy, 1984 https://pubmed.ncbi.nlm.nih.gov/6548968/ [^18]: DSIP in hospital patients withdrawing from alcohol or opioids, 1984 https://pubmed.ncbi.nlm.nih.gov/6548969/ [^19]: DSIP and how long rats sleep, 1979 https://pubmed.ncbi.nlm.nih.gov/530466/ [^20]: Blocking DSIP and slow-wave sleep after sleep loss in rats, Dallas, 1988 https://pubmed.ncbi.nlm.nih.gov/3368469/ [^21]: Review: DSIP, a still unresolved riddle, 2006 https://pubmed.ncbi.nlm.nih.gov/16539679/ [^22]: NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026 https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions [^23]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879