Are Peptides FDA-approved?
category: Health Optimization
Peptides have surged in popularity among men looking to optimize their health, lose weight, and boost physical performance. Between 2016 and 2022, the FDA-approved 26 peptides as drugs—skyrocketing their usage among the general public. But when our patients ask “are peptides FDA-approved,” the answer isn’t cut and dry.
Some FDA-approved peptides you may recognize include GLP-1 agonists like Ozempic, Wegovy, Zepbound, and Mounjaro, which are primarily used for diabetes and weight loss. Other examples include Tesamorelin (Egrifta) for managing fat buildup in HIV patients and PT-141 (Vyleesi) for libido and sexual performance.
However, many naturally occurring peptides haven’t been trademarked or patented but are still widely regarded as safe and effective. Today, we’re sharing everything you need to know about FDA approval for peptides, what’s safe to use, and how peptides can help you hit your health goals. Let’s dive in!
What are Peptides?
Peptides are short chains of amino acids that play a crucial role in keeping us healthy by serving as the building blocks of proteins. Some prescription peptides are identical to those naturally produced in the body.
On the other hand, there are some that aren’t naturally occurring but are designed to target specific pathways to optimize bodily functions. Depending on the peptide, they can support muscle growth, enhance tissue repair, promote fat loss, and even improve sleep quality.
Think of peptides as natural boosters for your body.
Some peptides can increase growth hormone production, which helps you build muscle and burn fat, while others might help you heal faster after an injury. Whether you’re looking to recover quicker, get leaner, or even sleep better—there’s a peptide that can help.
At Victory Men’s Health, we personalize our peptide recommendations to support each individual’s unique needs, whether it’s building muscle, improving recovery, or targeting visceral fat.
Do You Need a Prescription for Peptides?
It depends on the peptide. Some don’t require a prescription and are easy to get over the counter. Take creatine, for example. You find this peptide at most supplement stores, and it’s widely used for athletic performance.
For growth hormone-releasing peptides (GHRPs), on the other hand, you’ll need a prescription. Peptides which influence human growth hormone production (GHRHs) require a prescription. These include tesamorelin and sermorelin, which can have strong effects on your body and should be monitored by a healthcare provider.
At Victory Men’s Health, we only prescribe these types of peptides after we’ve done a consultation and comprehensive blood test to make sure they’re a good fit.
Are Any Peptides FDA-approved?
Yes! Several peptides are FDA-approved, which means they’ve gone through serious testing to prove they’re both safe and effective. When a peptide is FDA-approved, it’s passed clinical trials and has been thoroughly reviewed to ensure it works as intended without major risks.
Some of the FDA-approved peptides you’ve probably heard of include:
- Semaglutide (commonly seen under brand names Ozempic and Wegovy), which is approved for treating type 2 diabetes and weight loss.
- Tirzepatide (commonly seen under the brand name Mounjaro), another diabetes drug that’s becoming well-known for its weight loss benefits.
- Tesamorelin, which is approved to treat abnormal fat buildup in HIV patients but has other uses in wellness.
- PT-141 (Vyleesi), which is approved for libido and sexual health.
These peptides have passed the FDA’s strict review process and are considered safe for specific uses. However, some FDA-approved peptides are used off-label for broader health benefits.
What’s the FDA Approval Process for Peptides?
The FDA approval process is no joke. It’s designed to make sure any new drug is safe and effective before it’s made available to the public. Here’s a quick rundown of how it works for peptides.
- Discovery and Development: Researchers study molecular compounds to identify candidates for development. Once they’ve identified one, they begin experimenting to gather more information about it.
- Preclinical Research: Before human testing, the peptide is studied in labs and on animals to check for any major safety concerns.
- Clinical Trials: If the early testing goes well, the peptide moves on to human clinical trials. These trials are done in phases to see how safe and effective the peptide is for real people.
- FDA Review: After clinical trials, all the data gets sent to the FDA for a full review. The FDA makes the final call on whether the peptide should be approved for use.
- Post-Market Monitoring: Even after approval, the FDA keeps an eye on the peptide to catch any long-term side effects.
What are the Benefits of Peptides?
Peptides offer a wide range of health benefits that can enhance your overall health and well-being. Some of the most common benefits include:
- Improved sleep quality
- Enhanced fat loss and metabolism
- Increased lean muscle mass and better recovery
- Improved cognitive function and energy levels
- Reduced inflammation and faster tissue healing
We’ve seen these benefits firsthand in our patients, particularly in areas like gaining lean muscle, losing stubborn fat, and improving overall sleep and energy levels. By only prescribing compounded peptides (vs. FDA-approved peptides) in our clinics, we’re better able to tailor the treatment plan to the patient.
Peptides have helped transform many of our patients’ health, including patients who weren’t seeing the results they wanted with lifestyle changes alone.
Can You Use Non-FDA-approved Peptides?
Yes! Non-FDA-approved peptides are widely used and often effective. Although these peptides haven’t undergone the FDA approval process, they’re often compounded by FDA-regulated pharmacies that meet strict standards.
Compounded peptides offer flexibility in dosing and customization, which can be beneficial if a trademarked medication is on backorder, the patient has allergies to a component, or a non-standard dose is needed.
At Victory Men’s Health, we use compounded peptides from reputable pharmacies to provide safe, effective solutions. We ensure quality and safety through third-party testing and strict sterile procedures. So, even though these peptides aren’t FDA-approved, they’re crafted with high standards of care.
FDA-approved Peptides vs. Compounded Peptides: What’s the Difference?
FDA-approved peptides are manufactured under strict regulations with standardized potency, purity, and consistency. Compounded peptides, on the other hand, are prepared by compounding pharmacies based on a healthcare provider’s prescription. This option allows for a more personalized approach.
When sourced from a reputable pharmacy, compounded peptides offer a safe, effective, and tailored solution for your health goals.
Both FDA-approved and compounded peptides can deliver excellent results, and we ensure that all the peptides we prescribe meet high standards of quality. The key is finding the right fit for your unique needs, and we’re here to guide you every step of the way.
Where Can I Find Peptides for Health and Wellness?
At Victory Men’s Health, we offer a range of peptides that have helped our patients improve their health and achieve their goals. From Tesamorelin to Semaglutide and Tirzepatide, we can help you find the peptide that suits your needs.
The process starts with a consultation and comprehensive blood test at one of our clinics in Illinois or Missouri. We’ll work with you to determine which peptides are the best fit for your lifestyle, budget, and goals.
Begin Your Journey to Better Health and Vitality
Peptide therapy can be a powerful tool for optimizing health, but it’s important to make informed choices when adjusting your medications or supplement routine. At Victory Men’s Health, we’re dedicated to helping you navigate your options.
Together, we can find a solution that allows you to feel stronger and live better. Ready to take the next step? Contact us today to book a consultation and find out if peptides are the right solution for your health goals.
