Longevity Peptides: Healthy-Aging Research and What the Evidence Shows

Key Takeaways

• Compounds covered: Epithalon (Epitalon), GHK-Cu, FOXO4-DRI, Khavinson bioregulators (thymalin, epithalamin)
• Goal area: Longevity and healthy aging — telomere biology, cellular senescence, oxidative stress, and epigenetic regulation
• Evidence range: Spans a 6-to-8-year non-blinded, non-randomized Russian clinical program (Khavinson bioregulators) to a single landmark mouse study (FOXO4-DRI) to robust in vitro work (GHK-Cu). No Phase III RCT exists for any compound in this list for longevity endpoints.
• Regulatory range: Spans compounds with unsettled 503A compounding status (Epithalon, injectable GHK-Cu), compounds without a recognized U.S. compounding pathway (Khavinson bioregulators), and research-only compounds not approved for human use (FOXO4-DRI)
• Key biomarkers for longevity: IGF-1, hs-CRP, HbA1c, fasting glucose, lipid panel, comprehensive metabolic panel
• As of April 2026: No peptide discussed in this article is FDA-approved for longevity or healthy-aging use. FOXO4-DRI is not approved for any human use and is not available through Superpower or any licensed prescriber.
• Bottom line: Evidence quality varies enormously within this category; direct compound comparisons across different evidence tiers are not scientifically valid.

Understanding Longevity: The Biology

The scientific study of aging underwent a fundamental reframing in 2013 when López-Otín and colleagues proposed the Hallmarks of Aging framework, subsequently expanded in a 2023 update in Cell to twelve hallmarks including telomere attrition, cellular senescence, epigenetic alterations, loss of proteostasis, and chronic inflammation. López-Otín and colleagues, in the 2023 update, described how these interconnected processes collectively drive age-related dysfunction across organ systems — providing the scientific foundation for investigating targeted interventions.

Longevity peptides are mechanistically interesting precisely because they interact with specific hallmarks rather than addressing aging as a single undifferentiated process. Telomere-active peptides address the telomere attrition hallmark. Senolytics like FOXO4-DRI address cellular senescence. Antioxidant and gene-regulatory peptides like GHK-Cu address oxidative stress and epigenetic alterations. This specificity is both the scientific appeal of the category and why cross-compound comparisons require careful handling — they are not targeting the same mechanism.

Xiao and colleagues, reviewing peptide-based drug development in Signal Transduction and Targeted Therapy in 2025, documented the expanding landscape of peptide therapeutics across delivery platforms and therapeutic categories, establishing the broader clinical context in which longevity peptide research is developing. Sharma and colleagues, writing in Drug Discovery Today in 2023, reviewed the current status of peptide-based drug discovery, noting that while the field has grown significantly, the gap between preclinical promise and clinical evidence remains large for many compounds.

An important calibration: Tartiere, Freije, and López-Otín, in a 2024 paper in Frontiers in Aging framing the hallmarks as a conceptual framework for health and longevity research, noted that biomarker-based monitoring is central to evaluating any longevity intervention — which is where baseline biomarker testing becomes directly relevant to this conversation.

Peptides Studied for Longevity: A Quick Comparison

The following peptides have published evidence relevant to longevity biology. They are listed in order of the strength and depth of the available evidence, from most-studied to least in human-relevant contexts.

• Compound: Khavinson bioregulators (thymalin + epithalamin)
  Mechanism for longevity: Organ-specific peptide bioregulation — thymalin supports thymic/immune function; epithalamin supports pineal gland and melatonin rhythmicity; both proposed to restore age-related decline in peptide signaling
  Evidence: 6-to-8-year non-blinded, non-randomized clinical program in Russia (N=266 elderly subjects) reporting differences in all-cause mortality — methodology not directly comparable to U.S. randomized controlled trial standards; 20–40% lifespan extension reported in rodent models from a single laboratory program; human data drawn exclusively from the Khavinson research group's clinical programs
  FDA status: Not FDA-approved for any indication in the United States. Thymalin and epithalamin are tissue-extract peptide preparations that do not clearly satisfy the 503A bulk drug substance eligibility criteria under 21 U.S.C. § 353a(b)(1)(A)(i) (not a component of an FDA-approved drug, not in USP/NF, not on FDA's approved bulk substances list). They do not have a recognized U.S. compounding pathway
  SP availability: Not currently available through Superpower
  Route: Injectable (clinical program formulations)
• Compound: Epithalon (Epitalon; AEDG tetrapeptide)
  Mechanism for longevity: Telomerase activation and telomere elongation in somatic cells; epigenetic regulation of gene expression; pineal gland stimulation affecting melatonin synthesis
  Evidence: In vitro telomerase activation; animal lifespan extension and tumor reduction studies; human cell-line telomere elongation study (2025); human circadian restoration study
  FDA status: Not FDA-approved for any indication. As of April 22, 2026, removed from the FDA Category 2 bulk drug substance nominations list pending PCAC review; 503A compounding pathway is currently unsettled
  SP availability: Not currently available through Superpower
  Route: Subcutaneous injection; nasal spray
• Compound: GHK-Cu (copper peptide GHK)
  Mechanism for longevity: Antioxidant and anti-inflammatory activity; collagen and elastin synthesis stimulation; regulation of 4,000+ genes including those involved in DNA repair and longevity-related pathways
  Evidence: Extensive in vitro and preclinical data; human skin application studies (topical cosmetic); no human randomized controlled trial for systemic longevity endpoints
  FDA status: Topical cosmetic ingredient — regulated under FDA cosmetics law, no drug approval required. Injectable GHK-Cu is not an FDA-approved drug, is not currently on FDA Category 1, and its compounding eligibility under 503A is unsettled
  SP availability: Not currently available through Superpower for systemic longevity use
  Route: Topical (cosmetic); subcutaneous injection (compounded formulation)
• Compound: FOXO4-DRI
  Mechanism for longevity: Senolytic — selectively induces apoptosis in senescent cells by disrupting the FOXO4–p53 interaction that protects senescent cells from programmed death
  Evidence: A single landmark 2017 mouse study by Baar and colleagues in Cell; subsequent mouse model studies in specific tissue contexts; no human clinical trials
  FDA status: Not FDA-approved for any medical use; research-only compound not available for human use
  SP availability: Not legal to prescribe, compound, or dispense for human use in the United States
  Route: Intraperitoneal injection (animal studies only)

Compounds listed as research-only have not completed the clinical trial process required for FDA approval. FOXO4-DRI specifically is not legal to prescribe or sell for human use in the United States.

Peptides Studied for Longevity: Individual Profiles

Each compound is reviewed separately because mechanisms, evidence bases, and regulatory statuses differ substantially. The evidence hierarchy within this category spans from human clinical program data to single animal studies, and conflating these tiers misrepresents the state of the science.

Khavinson bioregulators: thymalin and epithalamin

The Khavinson bioregulators are tissue-specific peptide extracts developed by Vladimir Khavinson and colleagues at the Saint Petersburg Institute of Bioregulation and Gerontology beginning in the 1970s. Thymalin is derived from thymic tissue and supports immune system function; epithalamin is derived from pineal tissue and is proposed to regulate circadian rhythmicity and neuroendocrine function. Khavinson's 2002 review in Neuroendocrinology Letters proposed the peptide theory of aging — that declining synthesis of regulatory peptides in key organs drives age-related dysfunction — which underpins the entire bioregulator concept.

The longest-duration human data in this category comes from a 6-to-8-year non-blinded, non-randomized clinical program published by Khavinson in Neuroendocrinology Letters in 2003. In 266 elderly subjects, combined thymalin and epithalamin administration was associated with reported mortality differences in an unblinded clinical program compared with a standard-geriatric-care comparator. A companion analysis by Khavinson and colleagues in Advances in Gerontology in 2002 presented the combined treatment program data. These Russian clinical program results have not been reviewed or replicated under FDA or EMA methodology, and the trial designs are not directly comparable to US randomized controlled trial standards. As an observational clinical-program dataset rather than a randomized controlled trial, these data do not meet the evidentiary standard FDA requires for efficacy claims and are presented here as mechanism-generating rather than efficacy-establishing evidence.

Anisimov and colleagues, reviewing peptide bioregulation of aging in Biogerontology in 2010, documented 20 to 40% lifespan extension in rodent models and summarized 6 to 12-year human clinical follow-up data supporting the class. Korkushko and colleagues, writing in the Bulletin of Experimental Biology and Medicine in 2004, demonstrated that epithalamin restores circadian melatonin rhythm in elderly people — a mechanistically significant finding given melatonin's role in circadian regulation and oxidative stress protection.

Thymalin and epithalamin are not FDA-approved for any indication in the United States. As tissue-extract peptide preparations, they do not clearly satisfy the 503A bulk drug substance eligibility criteria under 21 U.S.C. § 353a(b)(1)(A)(i) (not a component of an FDA-approved drug, not in USP/NF, not on FDA's approved bulk substances list), and they do not have a recognized U.S. compounding pathway. Any clinical access in the United States would occur outside the 503A framework and carries substantial regulatory risk. They are not available through Superpower.

Epithalon (Epitalon; AEDG)

Epithalon is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) developed by Khavinson's group as a synthetic analog of epithalamin's active fraction. It is among the more widely studied synthetic bioregulators in the longevity context, primarily through Khavinson's laboratory program.

Khavinson and colleagues, publishing in the Bulletin of Experimental Biology and Medicine in 2003, demonstrated that Epithalon induces telomerase activity in human somatic cells — a mechanistically significant finding given that telomere attrition is one of the canonical hallmarks of aging. Khavinson and colleagues, in a 2004 paper in the same journal, showed that Epithalon enabled human fibroblasts to exceed the Hayflick limit and complete additional cell divisions. A 2025 study by Al-Dulaimi and colleagues in Biogerontology confirmed that Epitalon extends telomere length via telomerase upregulation or ALT activity in human cell lines, providing independent validation of the mechanism outside Khavinson's laboratory.

Anisimov and colleagues, in Biogerontology in 2003, showed Epitalon extended lifespan and reduced spontaneous tumor incidence in SHR mice. A 2002 paper by Anisimov and colleagues in the International Journal of Cancer reported reduced mammary tumor incidence in HER-2/neu mice — a preclinical-only oncology signal that requires careful framing. Khavinson and colleagues, in Molecules in 2020, described AEDG peptide stimulation of gene expression and neurogenesis through a possible epigenetic mechanism, supporting the broader view that Epithalon's effects extend beyond telomere biology.

Epithalon is not FDA-approved for any indication. As of April 22, 2026, epitalon was removed from the FDA Category 2 bulk drug substance nominations list pending PCAC review; removal from Category 2 is not equivalent to Category 1 approval, and during the PCAC review period the 503A compounding pathway for epitalon is unsettled. It is not currently available through Superpower.

GHK-Cu (copper peptide GHK)

GHK-Cu is a naturally occurring copper-binding tripeptide (Gly-His-Lys) present in human plasma, urine, and saliva, with concentrations that decline significantly with age. It functions as a signaling molecule and has been studied extensively for wound healing, collagen synthesis, antioxidant activity, and broad gene regulation.

Pickart and Margolina, in a 2018 review in the International Journal of Molecular Sciences, provided a comprehensive overview of GHK-Cu's regenerative and protective properties, including its capacity to modulate genes involved in collagen synthesis, inflammation, DNA repair, and mitochondrial function. A 2015 paper by Pickart and colleagues in Biomedical Research International described GHK as a natural modulator of multiple cellular pathways, reporting that GHK-Cu affects the activity of more than 4,000 human genes in cell-culture systems. The translation of this in vitro gene-regulatory breadth to clinical effect in humans has not been established. Pickart, writing in the Journal of Biomaterials Science in 2008, described GHK-Cu's effects on collagen, angiogenesis, and nerve outgrowth — systemic tissue repair mechanisms extending well beyond the skin.

Pickart and colleagues, in a 2012 paper in Oxidative Medicine and Cellular Longevity, reviewed GHK-Cu in oxidative-stress and aging biology, including implications for cognitive health — positioning it as a systemic longevity compound rather than purely a cosmetic ingredient.

GHK-Cu as a topical cosmetic ingredient is regulated under FDA cosmetics law with appearance-level claims only. Injectable GHK-Cu is not an FDA-approved drug and is not currently on FDA's Category 1 bulk drug substance list. Compounding pharmacies differ in their willingness to compound injectable GHK-Cu based on their interpretation of the current FDA nominations framework; this article is not a representation that injectable GHK-Cu can currently be legally compounded under 503A. It is not currently available through Superpower for systemic use.

FOXO4-DRI

FOXO4-DRI is a retro-inverso peptide — a synthetic version of a natural peptide sequence with D-amino acids and reversed orientation, which confers resistance to proteolytic degradation. It was designed to disrupt the FOXO4–p53 interaction that allows senescent cells to survive by sequestering p53 in nuclear bodies and preventing it from activating apoptotic programs.

The foundational study by Baar and colleagues, published in Cell in 2017, demonstrated that FOXO4-DRI induced targeted apoptosis of senescent cells, restoring tissue homeostasis in both progeroid and naturally aged mice. Treated progeroid mice showed improvements in fitness metrics and hair density. This paper is the foundational citation for FOXO4-DRI and is referenced throughout the subsequent research literature.

Subsequent work has extended the mechanistic platform. Zhang and colleagues, in Aging (Albany NY) in 2020, showed FOXO4-DRI alleviates age-related testosterone secretion insufficiency by targeting senescent Leydig cells in aged mice. Li and colleagues, in Experimental Gerontology in 2024, demonstrated improved spermatogenesis in aged mice through reduction of SASP secretion from Leydig cells. Kong and colleagues, in Communications Biology in 2025, showed FOXO4-DRI induces apoptosis in keloid senescent fibroblasts, demonstrating the mechanism extending to a new tissue type.

Xu and colleagues, in Nature Medicine in 2018, showed that senolytics (dasatinib and quercetin) improve physical function and lifespan in aged mice — contextualizing FOXO4-DRI within a class of interventions with demonstrated preclinical healthspan benefits. Chaib and colleagues, in a comprehensive review in Nature Medicine in 2022, reviewed the path to clinical translation for senolytics, placing FOXO4-DRI in context relative to the compounds that have advanced further toward human trials.

FOXO4-DRI is not FDA-approved for any medical use. Research is limited to laboratory and animal studies. Its safety, efficacy, appropriate dosing, and long-term effects in humans have not been established. FOXO4-DRI is not prescribed, compounded, or dispensed through Superpower. This information is for educational context only.

Regulatory Status at a Glance

As of April 2026, the peptides discussed in this article carry the following regulatory statuses.

• Khavinson bioregulators (thymalin, epithalamin): Not FDA-approved for any indication. As tissue-extract peptide preparations, they do not satisfy the 503A bulk drug substance eligibility criteria under 21 U.S.C. § 353a(b)(1)(A)(i). They do not have a recognized U.S. compounding pathway. Not available through Superpower.
• Epithalon (Epitalon; AEDG): Not FDA-approved for any indication. As of April 22, 2026, removed from FDA Category 2 bulk drug substance nominations list pending PCAC review. Removal from Category 2 is not equivalent to Category 1 approval; 503A compoundability during the review period is unsettled. Not available through Superpower.
• GHK-Cu: Topical formulations regulated under FDA cosmetics law with appearance-level claims only. Injectable GHK-Cu is not an FDA-approved drug and is not on FDA Category 1; compounding eligibility under 503A is unsettled. Not available through Superpower for systemic use.
• FOXO4-DRI: Research-only; not approved for human use. Not legal to prescribe, compound, or dispense for human use in the United States.

FOXO4-DRI is not legal to prescribe, compound, or sell for human use in the United States. Its presence in this article is for educational context only.

Considerations When Comparing Longevity Peptides

Direct comparison between these compounds is not straightforward — they have been studied in different populations, using different endpoints, and across entirely different evidence tiers. Inferring relative effectiveness from separate studies conducted in mice, cell cultures, and elderly Russian clinical cohorts is methodologically unreliable.

Target hallmark specificity: A provider evaluating longevity-oriented peptide options would first ask which hallmark or mechanism is most relevant to the patient's biomarker profile. An individual with elevated inflammatory markers and metabolic aging signals may have a different clinical picture from someone with a primary interest in telomere biology or senolytic activity. The biology presented in the "Understanding Longevity" section above is the starting point for that conversation.

Evidence level comfort: The compounds in this list span a range from 6-to-8-year human observational data (Khavinson bioregulators) to a single 2017 mouse study (FOXO4-DRI). Your provider will factor in how much clinical evidence supports a compound before recommending it. A compound with compelling mechanism and only mouse data is a fundamentally different clinical proposition from one with multi-year human program data, however imperfect the methodology.

Regulatory access pathway: FOXO4-DRI has no legal access pathway for human use in the United States. For Epithalon (removed from FDA Category 2 on April 22, 2026 pending PCAC review), injectable GHK-Cu (not FDA-approved and not on Category 1), and the Khavinson bioregulators (tissue-extract preparations without a recognized U.S. compounding pathway), 503A compoundability is unsettled or — in the case of the Khavinson bioregulators — not established under 21 U.S.C. § 353a(b)(1)(A)(i). Any U.S. pharmacy willing to dispense compounds in this regulatory posture is operating outside the 503A safe harbor, and readers should understand this as a regulatory-risk consideration rather than as a practical access pathway.

Existing biomarker profile: A baseline showing elevated hs-CRP, reduced IGF-1, worsening HbA1c, or lipid pattern changes provides objective context for which mechanisms are most active in a given individual — and therefore which peptide mechanisms are most mechanistically relevant. Without this data, a provider cannot make a clinically informed compound recommendation.

Combining compounds: Some longevity-oriented protocols involve combining compounds from different mechanism categories. Any such combination requires independent provider evaluation of each compound; the safety and efficacy of combining investigational compounds with different mechanisms is not established by the individual compound studies.

This is not an exhaustive list of clinical considerations. A licensed provider will evaluate your full health history, current medications, and baseline lab results before recommending any compound.

Safety Considerations

Safety profiles across this category range from well-characterized (GHK-Cu topical) to entirely unknown in humans (FOXO4-DRI). No blanket safety statement applies to longevity peptides as a class.

It is a long-established principle of drug development that preclinical safety data in animal models do not establish human safety profiles, and peptides marketed direct-to-patient have not generally undergone the long-duration human safety studies used to qualify approved drugs. For FOXO4-DRI specifically, the concern is not only lack of human safety data but also the theoretical risk of inducing apoptosis in non-target cell populations if specificity for senescent cells is not perfectly maintained in human biology — a question not addressable from mouse studies alone.

Contraindications that apply broadly to longevity peptide therapy include:

• Active or history of malignancy — compounds targeting cell proliferation, telomerase activity, or apoptotic pathways carry theoretical proliferative concerns requiring clinician evaluation; the preclinical anti-tumor signals for Epithalon should not be extrapolated to cancer protection in humans
• Pregnancy — no reproductive safety data exist for any compound in this category
• Active immunosuppression — compounds with immunomodulatory properties may interact with immunosuppressive regimens in ways not characterized by the available evidence
• Use of gray-market or unregulated sources — for any injectable compound, products obtained outside licensed pharmacy channels carry contamination and dosing risks that cannot be mitigated by the end user. For FOXO4-DRI specifically, there is no legal human-use pathway in the United States, so any source marketing FOXO4-DRI for human use is, by definition, operating outside the statutory framework.

For compound-specific safety profiles, see individual compound pages and consult a licensed provider.

What to Test Before Starting Longevity Peptides

Regardless of which compound you and your provider discuss, baseline biomarker testing establishes a measurable starting point. Without it, there is no objective way to assess whether a compound is producing the expected physiological changes — or whether those changes are beneficial. This principle is particularly important in longevity science, where changes in aging-relevant markers are gradual and confounders from lifestyle, metabolic health, and normal aging trajectory are substantial.

Biomarker monitoring is itself central to evaluating longevity interventions: a 2023 paper by Moqri and the Biomarkers of Aging Consortium in Cell identified biomarkers of aging as the necessary framework for identifying and evaluating longevity compound effects — positioning baseline testing not as a preliminary step but as the primary assessment method.

• IGF-1: The primary downstream marker of growth hormone axis activity, relevant to GH-related aging processes and the tissue-repair mechanisms that several longevity peptides aim to support. A baseline IGF-1 level characterizes GH axis function before any intervention.
• hs-CRP (high-sensitivity C-reactive protein): Chronic low-grade inflammation is one of the most consistent features of biological aging ("inflammaging"). hs-CRP provides the inflammatory baseline against which any anti-inflammatory peptide effect can be measured.
• HbA1c: A 90-day average of blood glucose reflecting metabolic aging trajectory. Elevated HbA1c is associated with accelerated biological aging across multiple organ systems. Baseline HbA1c makes any subsequent metabolic change interpretable.
• Fasting glucose and insulin: Insulin resistance is a central driver of metabolic aging. These two markers together characterize the current state of glucose metabolism and insulin sensitivity.
• Lipid panel: Cardiovascular aging trajectory and lipid-related risk characterization. Essential context for any systemic longevity evaluation.
• Comprehensive metabolic panel: Liver enzymes (ALT, AST) and kidney function (eGFR, creatinine) establish the organ function baseline and safety clearance for any injectable compound.
• CBC: Immune cell profile characterization — relevant baseline for any compound with immunomodulatory properties, including thymalin and thymosin alpha-1.

IGF-1, hs-CRP, HbA1c, fasting glucose and insulin, and a comprehensive metabolic panel establish the metabolic and inflammatory aging baseline that makes any change during a longevity peptide protocol interpretable. The longevity and cellular aging biomarker guide covers these markers in full.

How to Access These Peptides Safely

FOXO4-DRI has no legal access pathway for human use in the United States and is not available through any licensed prescriber or compounding pharmacy. Products sold as FOXO4-DRI online operate entirely outside pharmaceutical-grade manufacturing oversight.

For Epithalon and injectable GHK-Cu, 503A compoundability under FDA's bulk drug substance nominations framework is unsettled (see the Regulatory Status at a Glance section above for Category 1 vs. Category 2 status and the April 22, 2026 removal list). For Khavinson bioregulators, the situation is categorically different: as tissue-extract preparations, they do not satisfy the statutory 503A bulk drug substance eligibility criteria at 21 U.S.C. § 353a(b)(1)(A)(i), meaning compounding them would fall outside the 503A safe harbor entirely. Where any compounding pathway is pursued, it requires a clinical visit with a licensed provider, review of health history and laboratory results, and an informed consent discussion about the investigational status of these compounds.

Superpower does not provide or prescribe any of these compounds. Readers pursuing this pathway should do so with an independent licensed provider.

Topical GHK-Cu formulations are available over the counter as cosmetic ingredients and do not require a prescription — but cosmetic-grade formulations do not establish any drug-like efficacy claim, and the topical evidence base is limited to skin outcomes, not systemic longevity endpoints.

Self-directed use of injectable compounds obtained without a prescription creates dosing uncertainty, contamination risk, and the fundamental problem of having no provider-assessed baseline or monitoring capacity to evaluate any response.

Understanding Your Baseline

With multiple compounds available across widely different mechanism categories and evidence tiers, baseline biomarker data transforms a conversation with your provider from "which longevity peptide should I try" to "which compound addresses what my labs actually show." A person with elevated IGF-1 and low inflammatory markers has a fundamentally different longevity biology than someone with declining IGF-1 and chronic elevated hs-CRP — and the compound selection for those two profiles should differ accordingly.

That principle — test first, then decide — is central to Superpower's approach to preventive health. Whether or not a compounded peptide ends up being part of a clinical plan you discuss with your own provider, the starting point is the same: knowing where your biomarkers stand — the area Superpower's biomarker testing supports directly.

IMPORTANT SAFETY INFORMATION

Epithalon (Epitalon; AEDG tetrapeptide) is not FDA-approved for any indication in the United States. It is not a component of any FDA-approved drug product, does not appear in USP/NF, and is not on FDA's approved bulk drug substances list. As of April 22, 2026, epitalon was removed from FDA's Category 2 bulk drug substance nominations list pending PCAC review. Removal from Category 2 is not equivalent to Category 1 approval, and 503A compounding eligibility for epitalon is unsettled during the PCAC review period. Research on Epithalon's longevity effects consists primarily of in vitro studies and animal models, with human data from Khavinson's non-blinded clinical program. The safety and efficacy for longevity or healthy-aging indications have not been established through adequate and well-controlled FDA-reviewed clinical trials. Epithalon is not currently available through Superpower.

GHK-Cu (topical cosmetic use): GHK-Cu is regulated as a cosmetic ingredient when applied topically. Cosmetic ingredients are not evaluated or approved by the FDA to diagnose, treat, cure, or prevent any disease or medical condition. Physiological effect claims beyond appearance are not supported by FDA evaluation. Injectable GHK-Cu formulations are not FDA-approved drug products and are not currently on FDA Category 1; compounding eligibility under 503A is unsettled. Injectable GHK-Cu is not currently available through Superpower.

FOXO4-DRI is not approved by the FDA for any medical use. Research on FOXO4-DRI has been limited to laboratory and animal studies. Its safety, efficacy, appropriate dosing, and long-term effects in humans have not been established. FOXO4-DRI is not prescribed, compounded, or dispensed through Superpower. This page is provided for educational purposes only and does not constitute medical advice or an endorsement of use.

Khavinson bioregulators (thymalin, epithalamin) are not FDA-approved for any indication in the United States. As tissue-extract peptide preparations, they do not satisfy the 503A bulk drug substance eligibility criteria under 21 U.S.C. § 353a(b)(1)(A)(i) and do not have a recognized U.S. compounding pathway. Clinical data from Khavinson's programs reflects non-blinded clinical program data conducted in Russia, not FDA-reviewed randomized controlled trial evidence. These compounds are not currently available through Superpower.

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

Disclaimer:

This article discusses multiple peptide compounds with different regulatory statuses. FOXO4-DRI is not approved for human use. Epithalon was removed from FDA's Category 2 bulk drug substance nominations list on April 22, 2026 and is pending PCAC review; 503A compoundability during this review period is unsettled. Injectable GHK-Cu is not FDA-approved and is not on FDA Category 1. Khavinson bioregulators (thymalin, epithalamin) are tissue-extract peptide preparations without a recognized U.S. compounding pathway. None of the compounds discussed are FDA-approved for longevity or healthy-aging use. Superpower does not provide, prescribe, or facilitate access to any of the compounds discussed. This educational content is editorially independent.