Peptides for Hormone Balance: How Peptides Interact with Hormonal Pathways

Key Takeaways

• Compounds covered: Kisspeptin, sermorelin, ipamorelin/CJC-1295, thymosin alpha-1, GLP-1 receptor agonists (semaglutide/tirzepatide)
• Goal area: Hormonal health — spanning the HPG reproductive axis, the GH/IGF-1 axis, thymic immune-hormonal signaling, and insulin-mediated hormonal effects
• Evidence range: Ranges from Phase 3 RCTs (GLP-1 agonists for metabolic-hormonal effects) to academic clinical research (kisspeptin HPG axis) to review-level evidence (GH secretagogues in aging adults) to mechanistic/safety studies (thymosin alpha-1)
• Regulatory range: FDA-approved for other specific indications (GLP-1 agonists); compounded (kisspeptin, GH secretagogues, thymosin alpha-1); none FDA-approved for "hormone balance" as an indication
• Key biomarkers for hormonal health: LH, FSH, estradiol, testosterone, SHBG, IGF-1, prolactin, TSH, fasting insulin, HbA1c, cortisol
• As of April 2026: No peptide is FDA-approved for "hormone balance." Kisspeptin, GH secretagogues, and thymosin alpha-1 are compounded by prescription; GLP-1 agonists are FDA-approved for type 2 diabetes and weight management.
• Bottom line: "Hormone balance" spans multiple distinct hormonal systems; each peptide discussed targets one specific axis, requiring axis-specific biomarker evaluation before any clinical consideration.

Understanding Hormonal Balance: The Biology

Hormonal health is not a single biological state — it describes the coordinated function of multiple distinct endocrine axes, each regulated by its own feedback loops, stimulating peptides, and inhibitory signals. The term "hormone balance" implies a unified target, but clinical evaluation must specify which axis, which level of that axis, and which direction of imbalance is present.

Three hormonal systems are most frequently discussed in the context of peptide therapy. First, the hypothalamic-pituitary-gonadal (HPG) axis governs reproductive hormone production. Maggi and colleagues, reviewing GnRH and GnRH receptors in Human Reproduction Update in 2016, described the architecture of this axis: kisspeptin neurons signal GnRH release; GnRH drives pituitary LH and FSH secretion; LH and FSH stimulate gonadal steroidogenesis. Disruption at any level produces downstream hormonal changes, but the mechanism — and the appropriate intervention — differs depending on where the disruption originates.

Second, the hypothalamic-pituitary-somatotropic axis governs growth hormone and IGF-1. Di Somma and colleagues, describing somatopause in Minerva Endocrinologica in 2011, documented the progressive decline of GH secretory capacity with age and its metabolic consequences — a hormonal change occurring in parallel with HPG axis changes during midlife but through a completely separate mechanism.

Third, the stress axis (HPA) intersects both reproductive and metabolic systems. Saadedine and colleagues, in a 2025 review in Stress, characterized how cortisol dysregulation interacts with HPA-HPG cross-talk and sex hormone signaling by suppressing kisspeptin and GnRH pulsatility. This explains why chronic stress produces menstrual irregularity and reduced testosterone production: the suppression operates upstream at the kisspeptin level, not at the gonad.

Finally, insulin resistance creates a fourth hormonal disruption. Elevated insulin drives ovarian androgen production in women (PCOS mechanism) and suppresses hepatic SHBG synthesis, increasing free androgen bioavailability. GLP-1 receptor agonists have been studied in this pathway when insulin-hormonal crosstalk is the primary driver of hormonal dysregulation. Understanding which of these systems is involved — and at which level — is the necessary first step before any peptide is considered.

Peptides Studied for Hormone Balance: A Quick Comparison

The following peptides have published evidence relevant to specific hormonal pathways. They are listed by axis, then by evidence strength within each axis.

• Compound: GLP-1 receptor agonists (semaglutide, tirzepatide). Mechanism for hormonal health: Reduce hyperinsulinemia driving ovarian androgen excess; improve insulin sensitivity with downstream effects on SHBG and free hormone levels. Evidence: Phase 3 RCTs for metabolic outcomes; RCT-level PCOS metabolic data; no RCT for "hormone balance" as a primary endpoint. FDA status: FDA-approved for type 2 diabetes and weight management; hormonal effects in PCOS are off-label. SP availability: Available through Superpower's licensed provider network for its FDA-approved indications (weight management, type 2 diabetes); PCOS and hormonal uses would be off-label and are not promoted here. Route: Subcutaneous injection weekly.
• Compound: Sermorelin / ipamorelin / CJC-1295 (GH secretagogues). Mechanism for hormonal health: Stimulate pulsatile GH release via GHRH and ghrelin receptor pathways, supporting IGF-1 levels and GH axis function. Evidence: Phase 2 and review-level evidence in aging and hypogonadal adults; no Phase 3 RCT for general "hormonal health". FDA status: Not FDA-approved for hormonal health. Sermorelin was previously a component of the FDA-approved drug Geref (sermorelin acetate), which was withdrawn from the U.S. market in 2008. No FDA-approved sermorelin drug product currently exists; sermorelin has no USP or NF monograph; and sermorelin is on FDA's Interim List of Bulk Drug Substances Nominated for 503A Inclusion in Category 2 — the category assigned to substances for which FDA has identified significant safety risks and stated its intent to take enforcement action against 503A compounding. No lawful § 503A bulks compounding pathway is clearly established. Ipamorelin and CJC-1295 are not components of any FDA-approved drug, have no USP/NF monograph, and are placed in Category 2 on FDA's Interim List — failing all three statutory criteria under 21 U.S.C. § 353a(b)(1)(A) for lawful 503A bulk compounding. SP availability: Not currently available through Superpower. Ipamorelin and CJC-1295 are not on FDA's 503A Category 1 permitted bulk drug substances list and fail the statutory criteria for lawful 503A bulk compounding under 21 U.S.C. § 353a(b)(1)(A). Route: Subcutaneous injection.
• Compound: Kisspeptin. Mechanism for hormonal health: KISS1R agonist stimulating GnRH pulsatility; relevant when hypothalamic HPG axis suppression is the cause of low LH, FSH, and downstream gonadal hormones. Evidence: Academic clinical research (Dhillo group, Imperial College London) in HPG axis protocols, fertility, and sexual function; no RCT for general "hormone balance". FDA status: Not FDA-approved for any indication; not on the FDA 503A Category 1 permitted bulk drug substances list; US access is generally limited to academic research protocols; not available through Superpower. Route: Subcutaneous injection.
• Compound: Thymosin alpha-1. Mechanism for hormonal health: Thymic peptide hormone supporting T-cell maturation and immune axis regulation; relevant to immune-hormonal interface. Evidence: Safety review across 11,000+ human subjects (Dinetz et al., 2024); mechanistic studies; regulatory status varies by country. FDA status: Not FDA-approved in the US; not on the FDA 503A Category 1 permitted bulk drug substances list; the FDA Pharmacy Compounding Advisory Committee (PCAC) declined to recommend it for Category 1 inclusion. SP availability: Not available through Superpower. Route: Subcutaneous injection.

Peptides Studied for Hormone Balance: Individual Profiles

Each compound targets a different hormonal system. Profiles are grouped by axis and ordered by evidence strength within each axis.

GLP-1 receptor agonists and insulin-mediated hormonal effects

GLP-1 receptor agonists have been studied for the hormonal consequences of hyperinsulinemia. In women with PCOS, elevated insulin stimulates ovarian theca cells to produce excess androgens; simultaneously, it suppresses hepatic SHBG synthesis, raising free androgen bioavailability. Ni and colleagues, in a 2025 review in Frontiers in Endocrinology, documented this adipose-androgen crosstalk mechanism in detail, explaining how insulin-sensitizing interventions reduce androgen excess indirectly. Hudanich and colleagues, in a 2025 scoping review in Cureus, reviewed GLP-1 receptor agonist effects on PCOS metabolic and reproductive outcomes, finding scoping-review-level evidence of improved insulin sensitivity, reductions in elevated androgens in some patients, and in some studies improved cycle regularity. [Phase 3 RCTs for metabolic outcomes; PCOS hormonal effects are off-label applications]

GLP-1 agonists are FDA-approved for type 2 diabetes and weight management. Their hormonal effects in PCOS are a secondary effect of the primary metabolic mechanism, not an approved indication. Available through Superpower's licensed provider network for its FDA-approved indications; PCOS and hormonal uses would be off-label and are not promoted here. See the semaglutide and tirzepatide compound pages for detailed clinical information.

GH secretagogues and the growth hormone axis

Sermorelin, ipamorelin, and CJC-1295 act on the pituitary GHRH receptor (sermorelin, CJC-1295) and ghrelin receptor (ipamorelin) to stimulate pulsatile GH release. This is the physiological pattern of GH secretion — episodic bursts primarily overnight — rather than continuous GH replacement. Sinha and colleagues, reviewing GH secretagogues in Translational Andrology and Urology in 2020, documented Phase 2 / review-level improvements in lean mass and body fat distribution in hypogonadal adults receiving these compounds. Sigalos and colleagues, in a 2017 study in the American Journal of Men's Health, demonstrated that GH secretagogues raise serum IGF-1 — the primary downstream marker of GH axis function — in adults with documented GH decline. [Multiple Phase 2 / review-level evidence; no Phase 3 RCT for "hormonal health" as a primary endpoint]

GH secretagogues are not FDA-approved for hormonal health or somatopause. Sermorelin was previously a component of the FDA-approved drug Geref (sermorelin acetate), which was withdrawn from the U.S. market in 2008. No FDA-approved sermorelin drug product currently exists. Sermorelin has no USP/NF monograph and is placed in Category 2 on FDA's Interim List of Bulk Drug Substances Nominated for 503A Inclusion. No lawful § 503A bulks compounding pathway is clearly established; some compounding pharmacies continue to prepare sermorelin and the regulatory basis for this is contested. Ipamorelin and CJC-1295 are not currently available through Superpower. Neither is on FDA's 503A Category 1 permitted bulk drug substances list; neither is a component of an FDA-approved drug; and neither has a USP/NF monograph — failing all three statutory criteria under 21 U.S.C. § 353a(b)(1)(A) for lawful 503A bulk compounding. IGF-1 monitoring is standard clinical practice for any GH-axis intervention under specialist care. Kościuszko and colleagues, in a 2026 study in International Journal of Molecular Sciences, documented cardiovascular and body composition outcomes during 24-month GH therapy — relevant as a monitoring analog, not as direct evidence for GH secretagogue outcomes. Jakobsdóttir and colleagues, writing in Clinical Endocrinology in 2010, linked IGF-1 to body composition outcomes in community-dwelling older adults, supporting IGF-1 as the relevant tracking marker for GH axis interventions.

Kisspeptin and the reproductive HPG axis

Kisspeptin is the furthest-upstream signaling molecule in the reproductive hormone cascade. Nandankar and colleagues, writing in the American Journal of Physiology in 2021, documented that kisspeptin deficiency in the arcuate nucleus is associated with central hypogonadism — a condition where reproductive hormone production fails because the hypothalamic drive is absent, even though the pituitary and gonads are capable of responding. Patel and colleagues, in a 2024 review in the Annals of the New York Academy of Sciences, reviewed kisspeptin's therapeutic potential in functional hypothalamic amenorrhea — the clinical condition where HPG axis suppression (often stress- or nutrition-related) disrupts menstrual cycling.

Xu and colleagues, in their 2026 Comprehensive Physiology review, described kisspeptin neurons as an integrative node across the HPO, HPT, and HPA axes — explaining why kisspeptin signaling is sensitive to stress (via cortisol-mediated HPA suppression) and to thyroid status, not just to sex steroid feedback. Sharma and colleagues, in a 2020 review in the International Journal of Molecular Sciences, reviewed kisspeptin's role in stimulating both male and female gonadal function via GnRH, establishing its dual-sex applicability. [Academic clinical research; no completed RCT for general hormonal health]

Kisspeptin is not FDA-approved for any indication. It is not on the FDA 503A Category 1 permitted bulk drug substances list. Access in the US is generally limited to academic research protocols. It is not available through Superpower. Its clinical relevance is greatest when central HPG axis suppression is the documented mechanism — not when the issue is primary gonadal failure or age-related hormone decline unrelated to hypothalamic signaling.

Thymosin alpha-1 and immune-hormonal regulation

Thymosin alpha-1 occupies an unusual position in hormonal health discussions: it is primarily an immunological compound that operates through thymic T-cell maturation pathways, but it is classified alongside hormonal compounds because the thymus is an endocrine-type organ whose output (thymic hormones) declines with age in a pattern parallel to thymic involution.

Dinetz and colleagues, in a comprehensive 2024 review in Alternative Therapies in Health and Medicine, synthesized thymosin alpha-1 safety and efficacy evidence across over 11,000 human subjects spanning immunocompromised states, hepatitis B, and infectious disease contexts. Matteucci and colleagues, writing in International Immunopharmacology in 2023, studied thymosin alpha-1's mechanism of action including interaction with galectin-1 and immune-modulating pathways. Huang and colleagues, in a 2020 study in Neuroreport, showed thymosin alpha-1 attenuates inflammatory pain via the Wnt3a/β-catenin pathway, providing mechanistic evidence for its anti-inflammatory properties relevant to hormone-related inflammatory states. [Review-level and mechanistic evidence; immunological indications only; no evidence for sex hormone or GH axis effects]

Thymosin alpha-1 is not FDA-approved in the US for any indication (it holds approvals in other countries for hepatitis B and as an immunomodulator). It is not on the FDA 503A Category 1 permitted bulk drug substances list, and the FDA Pharmacy Compounding Advisory Committee (PCAC) declined to recommend it for Category 1 inclusion. It is not available through Superpower. Its classification as a "hormone balance" compound is a category convention rather than a mechanistic claim; it does not directly affect reproductive or growth hormone levels.

Regulatory Status at a Glance

As of April 2026, the peptides discussed in this article carry different regulatory statuses. None is FDA-approved for "hormone balance" as an indication.

• Semaglutide: FDA-approved as Ozempic (type 2 diabetes) and Wegovy (weight management); hormonal effects in PCOS are off-label.
• Tirzepatide: FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, obstructive sleep apnea); hormonal effects are off-label.
• Sermorelin: Not FDA-approved; was previously a component of Geref (sermorelin acetate), which was withdrawn from the U.S. market in 2008. No FDA-approved sermorelin drug product currently exists; no USP/NF monograph exists; placed in Category 2 on FDA's Interim List of Bulk Drug Substances Nominated for 503A Inclusion. No lawful § 503A bulks compounding pathway is clearly established.
• Ipamorelin: Not FDA-approved; not a component of any FDA-approved drug; not on the FDA 503A Category 1 permitted bulk drug substances list; compounding availability is subject to ongoing FDA bulk drug substance review.
• CJC-1295: Not FDA-approved; not a component of any FDA-approved drug; not on the FDA 503A Category 1 permitted bulk drug substances list; compounding availability is subject to ongoing FDA bulk drug substance review.
• Kisspeptin: Not FDA-approved for any indication; not on the FDA 503A Category 1 permitted bulk drug substances list; US access is generally limited to academic research protocols; not available through Superpower.
• Thymosin alpha-1: Not FDA-approved in the US; approved in other countries for immunological indications; not on the FDA 503A Category 1 permitted bulk drug substances list; the FDA Pharmacy Compounding Advisory Committee (PCAC) declined to recommend it for Category 1 inclusion; not available through Superpower.

Under Section 503A of the FD&C Act, a compounding pharmacy may only compound from a bulk drug substance if the substance is a component of an FDA-approved drug, is the subject of an applicable USP/NF monograph, or appears on the FDA's 503A Category 1 list. Peptides that do not meet one of these conditions are not lawfully available through 503A compounding.

Considerations When Comparing Peptides for Hormone Balance

The term "hormone balance" implies a unified goal, but the compounds above address four distinct biological systems: insulin-hormonal crosstalk (GLP-1 agonists), GH axis (GH secretagogues), HPG axis (kisspeptin), and immune-thymic axis (thymosin alpha-1). A compound relevant to one system provides no benefit to another — and may carry risks in populations where a different system is the primary concern.

Direct comparison between kisspeptin, GH secretagogues, and GLP-1 agonists for "hormonal health" carries significant methodological limitations. They have been studied in different populations, at different doses, and for different endpoints. There is no trial directly comparing these compounds for a shared hormonal health outcome.

Which hormonal axis is measurably dysregulated: Two individuals with seemingly similar hormonal symptoms can have different underlying axis dysregulation — for example, HPG suppression driven by stress vs. androgen excess driven by insulin resistance. Identifying the relevant axis requires clinician-interpreted laboratory evaluation, not pattern matching from symptoms alone.

Mandelli and colleagues, in a 2022 review in Climacteric, characterized osteosarcopenia as a distinct downstream consequence of estrogen loss that compounds with somatopause — illustrating that two different hormonal systems can drive similar clinical presentations (bone and muscle loss) through different mechanisms requiring different interventions.

Primary versus secondary hormonal disruption: Cortisol suppression of kisspeptin (via HPA-HPG crosstalk) produces low LH and low estradiol/testosterone that resembles hypogonadism but is actually driven by stress axis dysregulation. A compound targeting kisspeptin directly would be less effective if elevated cortisol continues to suppress the same neurons. Addressing the upstream driver — stress load, sleep, metabolic health — is part of the clinical conversation.

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 list are distinct. GLP-1 agonists have the most characterized safety data from large Phase 3 trials; the most common adverse effects are gastrointestinal and dose-dependent. GH secretagogues carry risks related to elevated IGF-1 including fluid retention, joint discomfort, and insulin resistance effects; periodic IGF-1 monitoring is standard. Kisspeptin's safety data comes from academic research protocols, not commercial compounding settings. Thymosin alpha-1 has an extensive safety record in immunological contexts, though long-term safety specifically in hormonal health contexts has not been characterized.

Contraindications that apply broadly to hormone-related peptide therapy include:

• Hormone-sensitive malignancy (current or history) — compounds affecting the GH/IGF-1 axis or reproductive hormone axes require oncology-aware provider evaluation
• Active autoimmune conditions — thymosin alpha-1 modulates immune function; provider evaluation of existing autoimmune status is required before use
• Pregnancy or planned pregnancy — GLP-1 agonists require discontinuation before conception; other compounds lack pregnancy safety data
• Multiple Endocrine Neoplasia type 2 or medullary thyroid carcinoma — contraindication for GLP-1 agonists per approved labeling
• Uncontrolled metabolic conditions — baseline metabolic evaluation required before initiating any compound affecting insulin, GH, or reproductive hormone axes

For compound-specific side effect profiles, see the individual compound pages linked above.

What to Test Before Starting Peptides for Hormone Balance

Regardless of which compound a provider discusses, 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.

• LH and FSH: The upstream pituitary gonadotropins that characterize HPG axis function. Testing LH and FSH distinguishes central (hypothalamic/pituitary) from primary (gonadal) causes of low sex hormones — the distinction that determines whether kisspeptin or other HPG-axis-targeted compounds are mechanistically relevant.
• Estradiol: The primary estrogen, reflecting ovarian function in women and aromatization status in men. A baseline estradiol establishes HPG axis output and characterizes any estrogen-driven hormonal changes.
• IGF-1: The primary downstream marker of growth hormone axis activity. A baseline IGF-1 is required before any GH secretagogue protocol and is the primary monitoring marker during therapy. Age-adjusted reference ranges apply.
• SHBG: Modulates the bioavailability of sex hormones. Testing SHBG at baseline contextualizes free hormone fractions and tracks changes with insulin-sensitizing interventions that affect hepatic SHBG production.
• Fasting insulin: Characterizes the degree of insulin resistance driving hormonal-metabolic crosstalk. Testing fasting insulin is particularly relevant when androgen excess, irregular cycles, or PCOS-pattern presentations suggest insulin-mediated hormonal disruption.
• Prolactin: Elevated prolactin suppresses GnRH and HPG axis function independently of other factors. Testing prolactin rules out hyperprolactinemia as a reversible cause of hormonal disruption before any HPG-axis-targeted compound is considered.
• TSH and thyroid panel: Thyroid dysfunction affects multiple hormonal axes including sex hormone metabolism and GH sensitivity. Testing TSH at baseline rules out thyroid pathology mimicking sex hormone or metabolic dysregulation.
• Cortisol: Elevated cortisol suppresses kisspeptin and GnRH pulsatility via HPA-HPG cross-talk. Baseline cortisol characterizes stress axis contribution to any apparent reproductive hormone imbalance.

LH, FSH, estradiol, IGF-1, SHBG, prolactin, and TSH together characterize the primary hormonal axes — reproductive, growth hormone, and thyroid — before any peptide intervention is considered. The hormonal balance and energy biomarker guide provides the clinical context for interpreting these markers. Baseline testing, 3-month follow-up, and 6-month reassessment give any intervention's effects a timeline against which changes can be objectively evaluated.

How to Access These Peptides Safely

Every injectable peptide discussed here requires a prescription. GLP-1 agonists are FDA-approved prescription medications obtained through a licensed prescriber and pharmacy. Sermorelin's 503A compounding context derives from its prior status as a component of an FDA-approved drug (Geref, since withdrawn). Ipamorelin, CJC-1295, thymosin alpha-1, and kisspeptin are not on FDA's 503A Category 1 permitted bulk drug substances list; lawful 503A compounding from these substances requires that they meet one of the statutory criteria under 21 U.S.C. § 353a, and their availability through compounding is the subject of ongoing FDA bulk drug substance review.

A provider evaluation for any hormone-related peptide involves: comprehensive hormone panel at minimum (relevant to the axis being considered); review of health history and current medications; symptom assessment; and clinical determination of which mechanism corresponds to the patient's documented hormonal pattern. Without this evaluation, the compound selection is speculative rather than evidence-informed.

Understanding Your Baseline

Hormonal health spans multiple distinct axes — HPG, GH, thyroid, HPA, and insulin-mediated — and different peptides address different subsets of these systems. No compound addresses "hormone balance" broadly; each targets specific receptors in specific pathways. Knowing which axes are measurably dysregulated in a specific individual is what makes "peptides for hormone balance" a meaningful clinical question rather than a marketing category.

That principle — test first, then decide — is central to Superpower's approach to preventive health. Whether the conversation with a provider leads to a GLP-1 agonist for insulin-mediated androgen excess, a GH secretagogue for documented somatopause, kisspeptin for central HPG suppression, or a non-pharmacological approach, the starting point is the same: objective biomarker data that reflects which hormonal axes are actually out of range and why.

IMPORTANT SAFETY INFORMATION

Semaglutide is FDA-approved as Ozempic for type 2 diabetes and Wegovy for chronic weight management. Use for hormonal balance or PCOS is off-label. Contraindications: personal or family history of medullary thyroid carcinoma or MEN2, known hypersensitivity. Warnings: thyroid C-cell effects (rodent data, clinical significance in humans under evaluation); pancreatitis; hypoglycemia with insulin or secretagogues; acute kidney injury. Common adverse effects: nausea, vomiting, diarrhea, constipation, abdominal pain. Full prescribing information at dailymed.nlm.nih.gov.

Tirzepatide is FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea). Hormonal applications are off-label. Class warnings and contraindications similar to semaglutide (see above). Full prescribing information at dailymed.nlm.nih.gov.

Sermorelin is not FDA-approved for any indication. Sermorelin was previously a component of Geref (sermorelin acetate, withdrawn 2008); no FDA-approved sermorelin drug product currently exists; sermorelin has no USP/NF monograph; and sermorelin is placed in Category 2 on FDA's Interim List of Bulk Drug Substances Nominated for 503A Inclusion. No lawful § 503A bulks compounding pathway is clearly established. Some compounding pharmacies continue to prepare sermorelin; the regulatory basis for this is contested. Safety and efficacy for hormonal health have not been established through adequate and well-controlled clinical trials.

Ipamorelin and CJC-1295 are not FDA-approved for any indication. Neither is a component of an FDA-approved drug; neither has a USP or NF monograph; and both are placed in Category 2 on FDA's Interim List of Bulk Drug Substances Nominated for 503A Inclusion — the category assigned to substances for which FDA has identified significant safety risks and stated its intent to take enforcement action against 503A compounding. Neither compound satisfies any of the three statutory criteria under 21 U.S.C. § 353a(b)(1)(A) for lawful 503A bulk compounding. Safety and efficacy for hormonal health have not been established.

Kisspeptin is not FDA-approved for any indication. It is not on the FDA 503A Category 1 permitted bulk drug substances list. US access is generally limited to academic research protocols. Not prescribed, compounded, or dispensed through Superpower. Safety and efficacy for general hormonal health have not been established through adequate and well-controlled clinical trials.

Thymosin alpha-1 is not FDA-approved for any indication in the United States. It is not on the FDA 503A Category 1 permitted bulk drug substances list, and the FDA Pharmacy Compounding Advisory Committee (PCAC) declined to recommend it for Category 1 inclusion. Dinetz et al. reviewed safety across 11,000+ subjects in immunological contexts. Safety and efficacy for hormonal health applications specifically have not been established. Not prescribed, compounded, or dispensed through Superpower.

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