Peptides & Performance
PEPTIDES EXPLAINED
What they are, how long they've been around, why some got banned, and why what you buy online might not be what you think it is.
WHAT ARE PEPTIDES?
Peptides are short chains of amino acids. Think of amino acids as letters and peptides as words—short sequences that carry a specific message. Proteins are the full sentences and paragraphs.
Technically, a peptide is any chain of 2 to about 50 amino acids. Above that, it's generally called a protein. Your body makes thousands of peptides naturally—insulin is a peptide, oxytocin is a peptide, the endorphins you feel after a workout are peptides.
Therapeutic peptides are lab-made versions of these natural signaling molecules. They work by binding to specific receptors in your body and triggering a targeted response: release more growth hormone, repair gut tissue, increase blood flow, reduce inflammation. The specificity is the appeal—peptides can do one thing precisely, with fewer off-target effects than broad-acting drugs.
Key distinction: Peptides aren't steroids, aren't hormones (though some trigger hormone release), and aren't supplements. They're signaling molecules—they tell your body to do something it already knows how to do.
PEPTIDES AREN'T NEW
The internet makes peptides feel like a bleeding-edge discovery. They're not. Scientists have been studying peptides for over a century.
1921 — Insulin Isolated
Insulin—a 51-amino-acid peptide—was isolated by Banting and Best. It became the first peptide therapy and has been used continuously for over 100 years. This is where peptide medicine starts.
1950s–1970s — Peptide Hormones Discovered
Researchers identified dozens of naturally occurring peptides: oxytocin, vasopressin, growth hormone-releasing hormone (GHRH), and many others. The understanding of peptides as the body's signaling system took shape.
1980s — Growth Hormone Releasing Peptides
Scientists developed synthetic peptides that could stimulate the pituitary gland to release growth hormone. This led to compounds like GHRP-6, GHRP-2, and eventually sermorelin—the first FDA-approved growth hormone releasing peptide (approved in 1997 as Geref).
1990s — BPC-157 & Healing Peptides
Dr. Predrag Sikiric's lab in Zagreb, Croatia began publishing research on BPC-157 (Body Protection Compound), a peptide derived from a protective protein found in gastric juice. Over 100 studies followed—mostly animal models—showing remarkable healing properties for tendons, ligaments, gut, and muscle. It became arguably the most popular peptide in the optimization world.
2000s–2010s — Expansion & Clinical Pipelines
Dozens of peptides entered pharmaceutical development pipelines. CJC-1295, ipamorelin, thymosin beta-4 (TB-500), AOD-9604, and others were studied in clinical trials for everything from growth hormone deficiency to wound healing to fat loss. Many showed promise in Phase I and II trials.
2019 — PT-141 Gets FDA Approval
Bremelanotide (PT-141) was approved by the FDA as Vyleesi for hypoactive sexual desire disorder in premenopausal women. It became one of the few modern peptides to complete the full FDA approval process.
2023–2024 — FDA Crackdown on Compounding
The FDA began removing peptides from compounding eligibility, effectively ending legal access to many popular compounds. BPC-157, thymosin alpha-1, thymosin beta-4, AOD-9604, and others were placed on the "cannot compound" list.
THE MOST TALKED-ABOUT PEPTIDES
Here's what each one does, where it came from, and whether you can still legally get it through a medical provider.
BPC-157
Not Available for CompoundingHealing & Recovery
What it does: Body Protection Compound-157 promotes healing of tendons, ligaments, muscle, gut lining, and potentially nerve tissue. It works by upregulating growth factor expression and promoting angiogenesis (new blood vessel formation) at injury sites.
The research: Over 100 published studies, almost entirely in animal models. Results are remarkably consistent—accelerated healing across multiple tissue types. However, no human clinical trials have been completed.
Why it's not available: The FDA determined that BPC-157 doesn't meet criteria for compounding under Section 503B. It has no history of use in compounding prior to 1998, no USP monograph, and no completed human trials supporting safety. The FDA finalized this decision in 2024.
Sermorelin
AvailableGrowth Hormone Release
What it does: Sermorelin is a growth hormone-releasing hormone (GHRH) analog. It stimulates your pituitary gland to produce and release more of your own growth hormone, particularly during sleep. Benefits include improved sleep quality, body composition, recovery, skin elasticity, and overall vitality.
The research: Sermorelin was FDA-approved in 1997 as Geref Diagnostic for growth hormone deficiency testing, and Geref for treatment of growth hormone deficiency in children. The manufacturer discontinued it voluntarily (business decision, not safety concern), but its extensive clinical history supports continued compounding.
Current status: Sermorelin can be prescribed by a medical provider and produced by a licensed compounding pharmacy. Its prior FDA approval history gives it a stronger regulatory footing than peptides that were never approved.
PT-141 (Bremelanotide)
AvailableSexual Health
What it does: PT-141 works on the melanocortin system in the brain—not blood flow like Viagra/Cialis. It increases sexual desire and arousal at a neurological level. Works for both men and women.
The research: Completed the full FDA approval process. Approved in 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. Well-studied in clinical trials with over 1,200 participants.
Current status: Fully FDA-approved and available through both brand-name prescription (Vyleesi) and compounding pharmacies. One of the few peptides with a complete safety and efficacy dataset.
CJC-1295 & Ipamorelin
Not Available for CompoundingGrowth Hormone Release
What they do: CJC-1295 is a GHRH analog (similar to sermorelin) that stimulates growth hormone release. Ipamorelin is a growth hormone-releasing peptide (GHRP) that works through a different receptor. They were commonly combined ("CJC/Ipamorelin") for a synergistic effect on growth hormone output.
The research: CJC-1295 was studied in Phase II clinical trials showing sustained growth hormone elevation. Ipamorelin was studied in multiple trials, including for post-operative ileus recovery. Both showed efficacy but neither completed the full approval process.
Why they're not available: Neither met FDA criteria for compounding eligibility. CJC-1295 with DAC (Drug Affinity Complex) was specifically flagged. The FDA removed both from compounding availability in 2024.
Thymosin Beta-4 (TB-500)
Not Available for CompoundingHealing & Recovery
What it does: TB-500 promotes wound healing, reduces inflammation, and supports tissue repair. It upregulates actin, a cell-building protein involved in cell migration and tissue repair. Was popular for joint, tendon, and muscle injuries.
The research: Studied in clinical trials for wound healing (particularly chronic skin wounds and corneal injuries). RegeneRx Biopharmaceuticals developed it through early clinical stages. Phase II trials showed promise for wound healing, but the company couldn't secure funding to continue through Phase III.
Why it's not available: Removed from compounding eligibility by the FDA. Like BPC-157, it lacks the regulatory history and completed human trial data the FDA requires for bulk compounding status.
Thymosin Alpha-1
Not Available for CompoundingImmune Support
What it does: Modulates and strengthens the immune system. Enhances T-cell function, natural killer cell activity, and overall immune surveillance. Used for immune deficiency, chronic infections, and as an adjunct in cancer treatment.
The research: This one is particularly notable—thymosin alpha-1 is approved as a pharmaceutical drug (Zadaxin) in over 35 countries for hepatitis B and C treatment, and as an immune booster. It's one of the most well-studied peptides in existence, with decades of clinical data.
Why it's not available in the US: Despite global approval, thymosin alpha-1 was never FDA-approved in the United States. The company (SciClone Pharmaceuticals) focused on international markets. When the FDA reviewed it for compounding eligibility, it didn't meet US-specific criteria. This is a case where FDA decisions don't reflect global medical consensus.
AOD-9604
Not Available for CompoundingFat Loss
What it does: AOD-9604 is a modified fragment of human growth hormone (amino acids 177-191). It was designed to have the fat-burning properties of growth hormone without the growth-promoting or blood sugar effects.
The research: Developed by Monash University in Australia. Phase II clinical trials showed fat loss without the side effects of full HGH. However, Phase IIb results were mixed, and the drug failed to achieve its primary endpoints in larger trials. The company pivoted to studying it for osteoarthritis.
Why it's not available: Never achieved FDA approval or met compounding criteria. Removed from compounding eligibility in 2024.
WHY PROMISING PEPTIDES STALL OUT
Here's a pattern that repeats across the peptide landscape: a compound shows real promise in early trials, then disappears from the clinical pipeline. People assume this means it didn't work. Usually, it means nobody could fund what comes next.
Getting a drug through FDA approval costs $1-2 billion on average and takes 10-15 years. For a pharmaceutical company, that investment only makes sense if they can patent the compound and recoup costs through exclusive sales.
Peptides present a problem: many are naturally occurring or simple enough that strong patent protection is difficult. If you spend $1 billion getting BPC-157 through Phase III trials and FDA approval, a compounding pharmacy can immediately make a generic version. The economics don't work for traditional pharma.
The Result
Dozens of peptides sit in a regulatory limbo: enough published research to suggest they work, but not enough FDA-quality clinical trial data to satisfy US regulatory requirements. They're not "unproven"—they're "underfunded."
The Catch-22
Without FDA approval, these peptides can't be marketed for medical use. Without a financial incentive to pursue FDA approval, no company will fund the trials. Without trials, they can't be approved. The cycle continues.
HOW THE FDA DECIDES WHAT'S ALLOWED
The FDA doesn't technically "ban" peptides. Here's what actually happens:
Compounding pharmacies operate under Section 503A and 503B of the Federal Food, Drug, and Cosmetic Act. These sections allow pharmacies to create custom medications—but only using "bulk drug substances" that meet specific criteria.
The FDA reviews nominated substances and places them into categories:
Can Be Compounded
The substance meets FDA criteria. Licensed compounding pharmacies can use it to fill prescriptions from medical providers. Examples: sermorelin.
Under Review
The substance has been nominated but FDA hasn't made a final determination. Status is uncertain and may change. Some pharmacies may still compound these while the review is pending.
Cannot Be Compounded
The substance doesn't meet FDA criteria. It cannot be legally compounded by 503B outsourcing facilities. This is what happened to BPC-157, TB-500, thymosin alpha-1, CJC-1295, ipamorelin, and others in 2024.
Important: "Not eligible for compounding" doesn't mean the peptide is dangerous or doesn't work. It means the FDA determined it doesn't meet the specific regulatory criteria for bulk compounding under current law. The FDA has stated it will continue to revisit these decisions as new data becomes available.
THE "RESEARCH CHEMICAL" PROBLEM
Search "BPC-157" online and you'll find dozens of websites selling peptides. Most display a disclaimer: "For research purposes only. Not for human consumption." This is how they operate in a legal gray area.
Here's what you need to understand about these products:
No Manufacturing Standards
Licensed compounding pharmacies operate under FDA oversight with strict manufacturing standards (cGMP or comparable). Research chemical companies don't. There's no required testing for purity, potency, sterility, or endotoxins. Quality varies wildly between companies—and between batches from the same company.
You Don't Know What's in the Vial
Third-party testing of "research" peptides has found: wrong peptide entirely, incorrect concentrations (sometimes 50% under or over), bacterial endotoxins, heavy metal contamination, and residual solvents from manufacturing. When you inject something, you need to know exactly what it is. These products don't give you that certainty.
No Dosing Guidance
Research chemical companies can't legally provide dosing instructions for human use. So people piece together protocols from Reddit threads, YouTube videos, and forum posts. This is how you get wrong doses, wrong injection sites, wrong reconstitution methods, and wrong frequency. Peptide dosing matters—too little does nothing, too much causes side effects.
No Medical Oversight
Nobody is monitoring your labs, watching for interactions with other medications, checking for contraindications, or adjusting your protocol based on response. Self-administering injectable compounds without medical oversight is a risk most people underestimate until something goes wrong.
The bottom line: The appeal is understandable—you've read about a peptide that could help, it's not available through your doctor, and someone online is selling it. But "research chemical" peptides are unregulated, untested, and injecting unknown substances into your body is a different category of risk than taking a questionable supplement.
CURRENT STATUS AT A GLANCE
This landscape changes as the FDA continues its review process. Last updated early 2025.
Available Through Medical Providers
Sermorelin
Growth hormone release. Previously FDA-approved.
PT-141 / Bremelanotide
Sexual health. FDA-approved as Vyleesi.
Additional peptides may be available depending on compounding pharmacy and ongoing FDA determinations. Ask your provider about current options.
Removed from Compounding (2024)
BPC-157
Healing & recovery
CJC-1295 (with or without DAC)
Growth hormone release
Ipamorelin
Growth hormone release
Thymosin Beta-4 (TB-500)
Healing & recovery
Thymosin Alpha-1
Immune support
AOD-9604
Fat loss
WHY SOURCING AND OVERSIGHT MATTER
The difference between peptide therapy done right and peptide therapy done wrong comes down to two things: what's in the vial and who's guiding the protocol.
Pharmaceutical-Grade Sourcing
Licensed compounding pharmacies test for identity, purity, potency, sterility, and endotoxins. Every batch. This isn't optional—it's required by law.
Proper Dosing Protocols
Dose, frequency, timing, injection technique, and reconstitution all matter. A medical provider builds your protocol based on your goals, health status, and response.
Monitoring & Adjustment
Lab work before and during therapy. Checking for interactions. Adjusting based on response. This is the difference between "I'm taking a peptide" and "I'm on a managed protocol."
COMMON QUESTIONS
Are peptides the same as steroids?
No. Steroids are synthetic hormones (typically testosterone derivatives) that directly supply the hormone. Peptides are signaling molecules that tell your body to do something—like produce more growth hormone. They work through different mechanisms and have very different risk profiles.
Are peptides safe?
When sourced from a licensed pharmacy and used under medical supervision with proper dosing, peptides like sermorelin and PT-141 have good safety profiles. The risk increases dramatically when using unregulated "research" products without medical oversight. Safety is a function of the compound, the source, and the supervision.
Will the FDA bring back any of the banned peptides?
It's possible. The FDA has said it will revisit decisions as new data becomes available. If a peptide completes adequate clinical trials or if Congress changes compounding laws, some compounds could return to compounding eligibility. But there's no timeline, and it would require significant effort and investment to make it happen.
What about oral peptides or peptide supplements?
Most peptides are broken down by digestive enzymes before they can be absorbed, which is why most are injected. Some companies sell oral peptide "supplements"—these are generally not effective for the same reasons. There are exceptions (BPC-157 was originally studied as an oral compound for gut healing), but most peptide supplements you see marketed online don't deliver what they promise.
How much do peptides cost through a medical provider?
At Moonshot, peptide therapy (sermorelin or PT-141) is $250/month, which includes the peptide from a licensed compounding pharmacy and medical oversight. Costs vary by provider and peptide. Insurance does not typically cover peptide therapy.
References
- 1. Sikiric P, et al. "Stable gastric pentadecapeptide BPC 157: novel therapy in gastrointestinal tract." Curr Pharm Des. 2011.
- 2. Teichman SL, et al. "Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295." J Clin Endocrinol Metab. 2006;91(3):799-805.
- 3. Kingsberg SA, et al. "Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder." Obstet Gynecol. 2019;134(5):899-908.
- 4. Walker RF. "Sermorelin: a better approach to management of adult-onset growth hormone insufficiency?" Clin Interv Aging. 2006;1(4):307-308.
- 5. Creos Ltd. "AOD-9604 Clinical Development Summary." Phase II Clinical Trial Data, 2007.
- 6. RegeneRx Biopharmaceuticals. "Thymosin Beta 4 Clinical Development Program." Phase II Data, 2010.
- 7. Garaci E. "Thymosin alpha1: from bench to bedside." Ann N Y Acad Sci. 2007;1112:225-232.
- 8. FDA. "Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act." Federal Register, 2024.
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