Peptides for Sleep: A Guide to Compounds Studied for Sleep Quality

Key Takeaways

• Compounds covered: DSIP, sermorelin (GHRH analog), epitalon (pineal peptide), BPC-157. Melatonin is a separate dietary-supplement category regulated under DSHEA, not a peptide compound, and is not profiled here.
• Goal area: Sleep quality, slow-wave sleep architecture, circadian rhythm context. This article is educational and is not intended to diagnose or treat any sleep disorder.
• Evidence range: Ranges from controlled human studies of GHRH effects on sleep EEG (distinct from sermorelin sleep trials, which do not exist) to animal-only data with indirect sleep relevance (BPC-157); no compound has Phase 3 human trial data for sleep as a primary endpoint
• Regulatory range: Sermorelin has a 503A pathway via the "component of an FDA-approved drug" route; DSIP, epitalon, and BPC-157 are not on the 503A Category 1 list, have no USP monograph, and are not components of any FDA-approved drug — none is lawfully compoundable under 503A in the US
• Key biomarkers for sleep: Cortisol (circadian function), TSH (thyroid), IGF-1 (GH-axis), hs-CRP (inflammation), vitamin B12 (melatonin synthesis pathway)
• As of April 2026: No peptide discussed in this article is FDA-approved for sleep enhancement. Sermorelin qualifies for 503A compounding via the component-of-approved-drug pathway and is prescribed off-label for GH-axis support, with no FDA-approved sleep indication. DSIP, epitalon, and BPC-157 sit on the FDA Category 2 interim list under active review, are not on Category 1, and are not lawfully compoundable under 503A.
• Bottom line: GHRH analogs have among the best-characterized mechanistic connections to sleep physiology in the literature referenced here; the sleep-specific evidence for all compounds remains preliminary, and no compound is FDA-approved for sleep indications.

Understanding Sleep: The Biology

Sleep is actively regulated by two systems operating in concert: the homeostatic sleep drive, which accumulates sleep pressure (driven partly by adenosine buildup) during wakefulness, and the circadian clock, anchored in the suprachiasmatic nucleus (SCN) and synchronized by light through melatonin signaling from the pineal gland.

Sleep architecture cycles through NREM and REM phases approximately every 90 minutes. NREM stage N3 — slow-wave or deep sleep — is characterized by high-amplitude delta-wave EEG activity and is the phase during which growth hormone is predominantly secreted, metabolic waste clearance (via the glymphatic system) is most active, and tissue repair is prioritized. REM sleep, concentrated in the second half of the night, supports memory consolidation and emotional regulation.

Peptide systems are integral to sleep architecture at multiple levels. A 1997 review by Steiger and colleagues in Sleep placed DSIP within a larger neuropeptide landscape including GHRH, CRH, somatostatin, and prolactin — all of which modulate human sleep architecture through distinct mechanisms. A 2003 review by Obal and Krueger in Frontiers in Bioscience characterized how peptide systems interact with sleep-wake circuitry, noting that neuropeptides regulate not just sleep onset but the internal structure of sleep stages.

The gut-brain axis adds another layer: serotonin, a precursor to melatonin and a modulator of REM sleep, is produced both centrally in raphe nuclei and peripherally in the gut; enteric serotonin does not cross the blood-brain barrier, so gut-brain serotonin signaling in sleep contexts operates through vagal and indirect mechanisms rather than direct CNS delivery. Orexin, ghrelin, and leptin — all peptide hormones or neuropeptides — influence sleep-wake transitions through overlapping hypothalamic circuits. A 2004 study by Dzaja and colleagues in the American Journal of Physiology — Endocrinology and Metabolism reported circadian rhythms of leptin, orexin, and ghrelin and their sleep-related fluctuations, establishing the breadth of peptide involvement in sleep regulation. A 2014 review by García-García and colleagues in Sleep Medicine Reviews reviewed ghrelin's interactions with GH, leptin, and orexins in the sleep-wake cycle.

Peptides Studied for Sleep: A Quick Comparison

The following peptides have published evidence relevant to sleep quality or architecture. They are listed by strength and directness of sleep-specific evidence, from most mechanistically established to most indirect.

• Compound: Sermorelin (GHRH analog)
  Mechanism for sleep: GHRH drives nocturnal GH pulse during slow-wave sleep; cortical GHRH receptors locally modulate delta-wave EEG activity
  Evidence: Controlled human studies of GHRH effects on sleep EEG and GH; no Phase 3 sleep efficacy trial for sermorelin specifically
  FDA status: Not FDA-approved for sleep. Qualifies for 503A compounding as a component of a previously FDA-approved drug (discontinued Geref) under 21 U.S.C. § 353a(b)(1)(A)(i). Compounded sermorelin is not itself FDA-approved for any indication; prescribing for adult GH-axis support is off-label.
  SP availability: Available through Superpower's licensed provider network, subject to clinical eligibility and provider evaluation
  Route: Subcutaneous injection
• Compound: DSIP (delta sleep-inducing peptide)
  Mechanism for sleep: Proposed delta-wave modulation; MAO-A regulation of serotonin; opioid peptide interactions; crosses blood-brain barrier
  Evidence: Small human studies (N typically under 30) from 1981–1992 reporting short-term sleep changes in insomniacs; replication has been inconsistent; no modern RCT
  FDA status: Not FDA-approved for any indication; not on the 503A Category 1 list; no USP monograph; not a component of any FDA-approved drug; currently on the FDA Category 2 interim list under active review. Not lawfully compoundable under Section 503A and not lawfully prescribable as a finished drug in the US
  SP availability: Not available through Superpower or any licensed prescriber
  Route: Intravenous in historical research studies (conducted outside the US under local institutional clinical research frameworks; no active US IND for sleep); no legitimate US clinical pathway exists. Online products sold as DSIP for human use are distributed outside FDA oversight and constitute unapproved new drugs in interstate commerce.
• Compound: Epitalon (pineal tetrapeptide)
  Mechanism for sleep: Proposed restoration of pineal melatonin production through gene expression modulation; melatonin rhythm normalization documented with epithalamin (the extract) in older adults
  Evidence: Small human and primate studies of the epithalamin extract; extrapolation to synthetic epitalon assumes equivalent pharmacology and has not been established; no Phase 3 sleep RCT
  FDA status: Not FDA-approved for any indication; not on the 503A Category 1 list; no USP monograph; not a component of any FDA-approved drug; currently on the FDA Category 2 interim list under active review. Not lawfully compoundable under Section 503A in the US
  SP availability: Not available through Superpower
  Route: Subcutaneous injection in research protocols
• Compound: BPC-157
  Mechanism for sleep: Indirect and speculative — gut serotonin and dopamine modulation via brain-gut axis in animal models; serotonin is a melatonin precursor and REM regulator
  Evidence: Animal models only for serotonin effects; no sleep outcome trials in humans
  FDA status: Not FDA-approved for any indication; not on the 503A Category 1 list; no USP monograph; not a component of any FDA-approved drug; currently on the FDA Category 2 interim list with a PCAC proposal pending. Not lawfully compoundable under Section 503A
  SP availability: Not available through Superpower
  Route: Subcutaneous injection or oral in research protocols

Compounds described here as not lawfully prescribable in the US are compounds that (i) have not received FDA approval as new drugs under 21 U.S.C. § 355, (ii) are not on the FDA 503A Category 1 list of bulk drug substances permitted for compounding, (iii) do not have an applicable USP monograph, and (iv) are not components of any FDA-approved drug — meaning there is no statutory pathway for a US pharmacy to compound or a US prescriber to prescribe them as finished drug products. Their inclusion here is for educational context only.

Peptides Studied for Sleep: Individual Profiles

Each compound below interacts with sleep biology through different mechanisms. A provider evaluating sleep-related peptide options would consider which mechanism addresses the specific disruption pattern — onset difficulty, poor slow-wave depth, circadian misalignment, or disrupted REM — rather than selecting from a ranked list.

Sermorelin and GHRH analogs

Sermorelin is a synthetic analog of growth hormone-releasing hormone (GHRH), consisting of the first 29 amino acids of endogenous GHRH — sufficient for full biological activity at the GHRH receptor. Its primary clinical use in compounding is GH-axis support in adults with low IGF-1.

Its sleep relevance derives from two distinct mechanisms. First, GHRH drives the nocturnal GH pulse: a 1992 study by Steiger and colleagues in Neuroendocrinology reported effects of GHRH and somatostatin on sleep EEG and nocturnal hormone secretion, establishing the primary citation for the GHRH-sleep connection. A 1996 review by Van Cauter and colleagues in The Journal of Pediatrics reviewed the physiology of GH secretion during sleep, establishing that the majority of daily GH release occurs during the first slow-wave episode.

Second, GHRH acts locally in the cortex to regulate slow-wave activity: a 2010 study by Szentirmai and colleagues published in The Journal of Neuroscience showed that disrupting cortical GHRH receptor signaling attenuates EEG delta waves, supporting the inverse inference that endogenous cortical GHRH signaling promotes slow-wave activity. A 2003 study by Weikel and colleagues in the American Journal of Physiology — Endocrinology and Metabolism demonstrated that ghrelin promotes slow-wave sleep in humans, reinforcing that GH-axis peptide signaling has direct sleep-architecture effects. A 1998 study by Obál and colleagues in the American Journal of Physiology reported evidence against a role for the growth hormone-releasing peptide (GHRP) axis — distinct from GHRH — in human slow-wave sleep regulation, a negative-result finding that underscores the specificity of the GHRH-slow-wave-sleep connection. [Phase II / controlled human studies for GHRH; no Phase 3 sleep RCT for sermorelin]

Sermorelin acetate was historically FDA-approved as a diagnostic agent for evaluating pediatric growth hormone deficiency (the reference-listed drug, Geref, has been discontinued from commercial distribution). It qualifies for 503A compounding as a component of a previously-approved drug under 21 U.S.C. § 353a(b)(1)(A)(i). Compounded sermorelin prescribed for adult GH-axis support is an off-label use; there is no FDA-approved indication for sermorelin in adult GH-axis support or in sleep enhancement, and compounded sermorelin is not the same as any FDA-approved drug product. Sermorelin is accessible through licensed prescribers for GH-axis evaluation, subject to clinical eligibility. A provider evaluating sermorelin for GH-axis support would assess baseline IGF-1 and clinical GH status — not specifically sleep architecture, which is a secondary consideration in those discussions.

DSIP (delta sleep-inducing peptide)

DSIP is a nonapeptide (9 amino acids) first isolated from rabbit brain in 1974 and subsequently characterized as having sleep-inducing properties in multiple species.

The primary human sleep evidence: a 1987 controlled study by Schneider-Helmert and colleagues in the International Journal of Clinical Pharmacology Research reported short-term sleep changes in chronic insomniacs and a 1981 study by the same group in Experientia reported sleep duration and quality changes without daytime sedation. These studies are small and dated. A 2006 review by Pollard and colleagues in the Journal of Neurochemistry concluded DSIP remains "a still unresolved riddle" due to inconsistent replication. [Early human studies, small N; replication inconsistent]

DSIP has not been approved by the FDA for any medical use. It is not on the FDA 503A Category 1 list, has no USP monograph, and is not a component of any FDA-approved drug — so it is not lawfully compoundable under Section 503A and not lawfully prescribable as a finished drug product in the US. DSIP currently sits on the FDA Category 2 interim bulk-substance list. Online products sold as DSIP for human use are distributed outside FDA oversight and constitute unapproved new drugs in interstate commerce; "Research Use Only" labeling by sellers does not cure this where the intended use of human consumption is evident (21 CFR 201.128). Inclusion here is for educational context only.

Epitalon (pineal tetrapeptide)

Epitalon is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) derived from epithalamin, a natural pineal polypeptide extract studied by Vladimir Khavinson and colleagues in Russia over several decades. Its proposed mechanism for sleep involves restoring pineal gene expression, which supports melatonin production in aging subjects whose pineal function has declined.

A 2007 study by Korkushko and colleagues in Advances in Gerontology reported that pineal gland peptides normalize the daily melatonin rhythm in older adults and monkeys. A 2004 study by Khavinson and colleagues in the Bulletin of Experimental Biology and Medicine showed epithalamin corrects circadian melatonin rhythm in older adults. It is important to note that the evidence cited here is predominantly for epithalamin (the pineal polypeptide extract), not for synthetic epitalon (Ala-Glu-Asp-Gly); extrapolation from epithalamin to synthetic epitalon assumes equivalent pharmacology, which has not been established. These findings are relevant to age-related sleep changes specifically, not to sleep problems in younger populations with intact pineal function. A 2025 overview by Araj and colleagues in the International Journal of Molecular Sciences provides a recent summary of epitalon research. [Small human and primate studies, primarily of the epithalamin extract; no Phase 3 sleep RCT for epitalon]

Epitalon is not FDA-approved for any indication. As of April 2026, epitalon is not on the FDA 503A Category 1 list of bulk drug substances permitted for compounding, does not have a USP monograph, and is not a component of any FDA-approved drug — so it is not lawfully compoundable under Section 503A in the US. It currently sits on the Category 2 interim list under active review. Some compounding pharmacies have historically dispensed epitalon in reliance on interpretations FDA has not formally endorsed. Epitalon is not available through Superpower.

BPC-157

BPC-157 is a synthetic 15-amino-acid peptide derived from a protein sequence in human gastric juice, primarily studied for gut healing, vascular effects, and CNS activity in animal models. Its proposed sleep relevance is indirect.

The proposed pathway involves the gut-brain axis: a 2016 review by Sikiric and colleagues in Current Neuropharmacology covered BPC-157's brain-gut axis effects including modulation of serotonin and dopamine. A 2023 review by Sikiric and colleagues in Biomedicines described BPC-157's role in recovering brain-gut and gut-brain axis function. A 2005 study by Sikiric and colleagues in the European Journal of Pharmacology reported BPC-157 effective against serotonin syndrome in rats, and a companion 2004 study in Life Sciences measured region-specific serotonin synthesis changes. A 2024 review by Sikiric and colleagues in Pharmaceuticals reviewed BPC-157's pleiotropic activity and neurotransmitter interactions. A 2025 review by Jozwiak and colleagues in Pharmaceuticals provides a recent comprehensive overview of BPC-157's multifunctionality. [Animal studies only for serotonin/sleep relevance; no human sleep trials]

BPC-157 is not FDA-approved for any indication. As of April 22, 2026, BPC-157 is not on the FDA 503A Category 1 list, has no USP monograph, and is not a component of any FDA-approved drug — so it does not qualify for lawful 503A compounding. It currently sits on the FDA Category 2 interim list with a PCAC proposal under review; Category 2 is an interim administrative status, and any removal from Category 2 would not by itself make BPC-157 compoundable under 503A. A substance removed from Category 2 returns to the default state of "not on any 503A qualifying list," which is still not compoundable. Readers should verify status with a licensed compounding pharmacist or FDA's published Category 1 list for any material regulatory decision. BPC-157 is not available through Superpower. Its sleep-relevance claim is speculative extrapolation from animal gut-brain serotonin biology, not validated in sleep outcome trials.

Regulatory Status at a Glance

As of April 2026, the peptides discussed in this article carry different regulatory statuses. These distinctions matter when discussing any of them with a healthcare provider.

• Sermorelin: Not FDA-approved for sleep enhancement. Qualifies for 503A compounding as a component of a previously FDA-approved drug (discontinued Geref) under 21 U.S.C. § 353a(b)(1)(A)(i). Compounded sermorelin prescribed for adult GH-axis support is off-label and not itself FDA-approved for that indication.
• DSIP: Not FDA-approved for any indication. Not on the FDA 503A Category 1 list, no USP monograph, not a component of any FDA-approved drug — not lawfully compoundable under Section 503A and not lawfully prescribable as a finished drug in the US. Currently on the Category 2 interim list.
• Epitalon: Not FDA-approved for any indication. Not on the 503A Category 1 list, no USP monograph, not a component of any FDA-approved drug — not lawfully compoundable under Section 503A. Currently on the Category 2 interim list under active review.
• BPC-157: Not FDA-approved for any indication. Not on the 503A Category 1 list, no USP monograph, not a component of any FDA-approved drug — not lawfully compoundable under Section 503A. Currently on the Category 2 interim list with a PCAC proposal pending; Category 2 removal would not by itself make BPC-157 compoundable under 503A.

Compounds in this article that are described as not lawfully prescribable in the US fail all four statutory pathways under 21 U.S.C. § 355 and § 353a(b)(1)(A): not FDA-approved, not on the FDA 503A Category 1 list, no applicable USP monograph, and not a component of any FDA-approved drug. They are presented here for educational context only. Online products sold as these compounds for human use are distributed outside FDA oversight and constitute unapproved new drugs in interstate commerce; "Research Use Only" labeling does not cure this where the intended use of human consumption is evident (21 CFR 201.128).

Considerations When Comparing Peptides for Sleep

Direct comparison between these compounds is not appropriate — they target different mechanisms, were studied in different populations, and none have been compared head-to-head in a controlled human trial.

What is driving the sleep disruption: The most consequential variable is the specific mechanism underlying poor sleep. Cortisol dysregulation, thyroid dysfunction, low GH-axis activity with reduced slow-wave depth, circadian melatonin disruption in aging, or gut-brain serotonin imbalance each represent different biology and would theoretically implicate different compounds. Pursuing any peptide before identifying the mechanism is an inversion of the appropriate clinical sequence.

Evidence level and mechanism quality: Endogenous GHRH has among the best-characterized mechanistic connections to slow-wave sleep architecture in the literature referenced here, supported by controlled human studies of GHRH effects on sleep EEG. Sermorelin, as a GHRH analog, shares the receptor pharmacology but has not been studied in controlled sleep trials. Pineal peptides have small human studies of the epithalamin extract in circadian melatonin contexts. DSIP has the most sleep-specific historical research but no modern trials. BPC-157 has no sleep trials at all.

Regulatory access: Sermorelin is accessible through licensed prescribers for GH-axis evaluation under a 503A pathway, subject to clinical eligibility. DSIP, epitalon, and BPC-157 are not lawfully compoundable under Section 503A in the US and are not lawfully prescribable as finished drug products. These access differences are material to any clinical conversation.

Age and GH-axis status: GHRH analogs are most relevant when IGF-1 levels are below the reference range for age, indicating reduced GH-axis activity. Pineal peptides are most studied in aging populations with documented melatonin rhythm decline. Younger individuals with normal GH axis and intact pineal function may not be the appropriate target population for either compound.

This is not an exhaustive list of clinical considerations. A licensed provider will evaluate health history, current sleep patterns, lab values, and current medications before recommending any compound.

Safety Considerations

Side effects vary by compound class and individual response. No blanket safety claim applies to sleep peptides as a category.

Injectable peptides carry universal risks: injection-site reactions, sterility concerns with improper technique, and contamination risks for sourced products. Sermorelin's safety profile in compounded form mirrors its profile as an approved diagnostic — GH-related effects at supra-physiologic doses include fluid retention, joint discomfort, and transient glucose effects. Epitalon's small human studies have not reported significant adverse effects, but long-term safety data from large controlled trials does not exist. DSIP and BPC-157 lack clinical safety data for sleep applications. A 2026 review by Mendias and colleagues in Sports Medicine reviewed safety and efficacy data for approved and unapproved peptide therapies, noting that unapproved compounds have limited rigorous human safety data.

Contraindications that apply broadly to sleep peptide therapy include:

• Pregnancy and breastfeeding: none of the compounds in this article have established reproductive safety data
• Active or history of hormone-sensitive malignancy: GH-axis peptides carry theoretical concern regarding GH/IGF-1 proliferative signaling
• Known hypersensitivity to any compound in this class
• Sourcing from unregulated vendors: products sold outside licensed pharmacy channels carry contamination, dosing, and misidentification risks

For compound-specific side effect profiles, consult a licensed provider and verify current prescribing information through a qualified pharmacist.

What to Test Before Starting Peptides for Sleep

Baseline biomarker testing establishes the biology underlying sleep disruption. Multiple systemic conditions manifest as poor sleep — and most are identifiable through standard bloodwork. Without a baseline, any intervention lacks a reference point for assessing change, and the underlying cause may go unaddressed.

• Cortisol: Dysregulated cortisol is a primary driver of sleep onset difficulty, middle-of-night waking, and non-restorative sleep. The sleep quality and circadian rhythm biomarker guide identifies cortisol as a key marker for this reason. Ideally assessed with morning and evening measurements to characterize the diurnal pattern.
• TSH: Thyroid dysfunction is among the most common underdiagnosed causes of sleep disruption. Both hypothyroidism and hyperthyroidism alter sleep architecture. Baseline TSH is a standard first-line screen.
• IGF-1: The primary downstream marker of growth hormone activity. A baseline IGF-1 level characterizes GH-axis function and is a key pre-treatment marker for any GHRH analog consideration. Low IGF-1 for age is one indicator of reduced GH-axis activity.
• hs-CRP: Systemic inflammation activates the HPA axis and disrupts sleep architecture. Baseline hs-CRP quantifies inflammatory burden and identifies a modifiable contributor to poor sleep that should be addressed regardless of which compound is considered.
• Vitamin B12: B12 is involved in the synthesis pathway for melatonin and in the regulation of the circadian wake-sleep cycle. Vitamin B12 deficiency is a correctable cause of sleep disruption that is easily missed without systematic testing.
• Comprehensive metabolic panel: Liver and kidney function baselines are relevant safety context for any injectable compound. Glucose dysregulation — reflected in fasting glucose — also impairs sleep architecture independently.
• CBC: Iron-deficiency anemia and hemoglobin levels affect sleep quality and are associated with restless legs syndrome. Ferritin should accompany CBC for anyone with suspected iron deficiency.

Cortisol, TSH, and IGF-1 together characterize the three hormonal systems most directly linked to sleep architecture: the stress-axis, thyroid function, and GH-axis activity. These markers should precede any discussion of peptide sleep support and may themselves identify the cause of sleep disruption without requiring any compound intervention.

How to Access These Peptides Safely

Compounded sermorelin is available through licensed healthcare providers who can evaluate eligibility, order baseline labs, and prescribe through licensed compounding pharmacies under Section 503A via the component-of-approved-drug pathway, for off-label GH-axis support. A provider evaluation for sleep-related peptide considerations typically involves assessment of the underlying sleep complaint, relevant lab values (IGF-1, cortisol, TSH), health history, and a discussion of current medications and their potential interactions. Epitalon availability through Superpower is not offered; epitalon is not lawfully compoundable under Section 503A in the US.

DSIP, epitalon, and BPC-157 are not on the 503A Category 1 list, have no USP monograph, and are not components of any FDA-approved drug; none is lawfully compoundable under Section 503A in the US as of April 2026. Online sellers distributing DSIP, epitalon, or BPC-157 for human use are distributing unapproved new drugs in interstate commerce in violation of 21 U.S.C. § 355(a). "Research Use Only" labeling by sellers does not cure this where the intended use of human consumption is evident (21 CFR 201.128 intended use doctrine). These products have not been evaluated by FDA for identity, purity, strength, safety, or efficacy.

Self-directed use of injectable peptides without provider involvement creates risk on multiple dimensions: dosing uncertainty, contamination from unregulated sources, inability to monitor GH-axis or metabolic changes, and no framework for evaluating whether sleep outcomes are actually changing. The appropriate entry point for any peptide sleep conversation is a clinical evaluation with a licensed provider who can order relevant baseline labs and determine whether any compound is appropriate for the specific clinical picture.

Understanding Your Baseline

The peptide sleep landscape illustrates a consistent principle: mechanistic rationale and clinical validation are different things. GHRH's role in slow-wave sleep is well established — the physiology is real. Translating that physiology into a reliable sleep intervention for a specific individual requires knowing that individual's GH-axis status, cortisol pattern, thyroid function, and inflammatory burden first. Without those data points, a peptide selection is an educated guess rather than a targeted intervention.

That principle — test first, then decide — is central to Superpower's data-first approach to health. Whether the conversation with a provider leads to a GHRH analog, a pineal peptide, a correction of cortisol dysregulation, or a B12 repletion, the starting point is the same: understanding what your biomarkers actually show before selecting any compound.

IMPORTANT SAFETY INFORMATION

Sermorelin is not FDA-approved for sleep enhancement. Sermorelin acetate was historically FDA-approved as a diagnostic agent for pediatric GH deficiency (reference-listed drug discontinued). It qualifies for 503A compounding as a component of a previously FDA-approved drug under 21 U.S.C. § 353a(b)(1)(A)(i); compounded sermorelin prescribed for adult GH-axis support is off-label and not itself an FDA-approved drug product. Side effects associated with GH-axis stimulation include injection-site reactions, fluid retention, joint discomfort, and transient effects on glucose metabolism. Contraindications include active neoplasm, hypersensitivity, pregnancy and breastfeeding (safety not established). Superpower facilitates access to compounded sermorelin through licensed providers and pharmacy partners for off-label adult GH-axis support; any such use is at the treating provider's clinical judgment and is not an FDA-approved indication.

DSIP is not approved by the FDA for any medical use. It is not on the FDA 503A Category 1 list, has no USP monograph, and is not a component of any FDA-approved drug — meaning it is not lawfully compoundable under Section 503A and not lawfully prescribable as a finished drug product in the US. DSIP currently sits on the FDA Category 2 interim bulk-substance list. Its safety, efficacy, appropriate dosing, and long-term effects in humans have not been established. DSIP is not prescribed, compounded, or dispensed through Superpower. Online products sold as DSIP for human use are distributed outside FDA oversight and constitute unapproved new drugs in commerce; "Research Use Only" labeling does not cure this where intended use for human consumption is evident (21 CFR 201.128).

Epitalon is not FDA-approved for any indication. It is not on the FDA 503A Category 1 list, has no USP monograph, and is not a component of any FDA-approved drug — meaning it is not lawfully compoundable under Section 503A in the US. It currently sits on the Category 2 interim list under active review. Human clinical data is limited to small studies, primarily of the epithalamin extract; long-term safety at any dose has not been established through adequate and well-controlled trials. Contraindications include pregnancy, breastfeeding, and active hormone-sensitive malignancy. Epitalon is not prescribed, compounded, or dispensed through Superpower.

BPC-157 is not approved by the FDA for any medical use. As of April 2026, BPC-157 is not on the FDA 503A Category 1 list, has no USP monograph, and is not a component of any FDA-approved drug — meaning it is not lawfully compoundable under Section 503A. It currently sits on the Category 2 interim list with a PCAC proposal pending; Category 2 removal, if it occurs, would not by itself make BPC-157 compoundable under 503A. Its safety, efficacy, appropriate dosing, and long-term effects in humans have not been established. BPC-157 is not currently prescribed, compounded, or dispensed through Superpower. This information is provided for educational purposes only.

Full FDA-approved prescribing information at dailymed.nlm.nih.gov.

Disclaimer: This article discusses multiple peptide compounds with different regulatory statuses. Some are available through compounding; others are not approved for human use. Superpower Health facilitates access to some but not all compounds discussed. This educational content is editorially independent.