By Dr. Ashley Shrader, DNP, IFMCP
Something is shifting in the peptide space — and if you’ve been paying attention to health & wellness conversations online, you’ve probably noticed. There’s a lot of noise right now: excitement, hype, and some legitimate concern. I want to give you a grounded, honest perspective on where things stand, what I actually prescribe and why, and what the risks are when people try to navigate this on their own.
Let’s start with the regulatory piece, because it’s relevant to why this conversation is happening now.
What’s Changing with Peptide Access
For the past several years, many peptides have been restricted under FDA compounding rules. Specifically, a number of commonly discussed peptides were placed into what’s called “Category 2” — meaning they couldn’t be legally compounded by licensed pharmacies and prescribed by physicians, even though they were being widely used in clinical settings outside the U.S.
That’s created a strange situation: these compounds have real clinical research behind them, but the regulatory pathway for accessing them safely — through a licensed provider, from a verified pharmacy — has been limited. The result? A lot of people have been sourcing them through unregulated channels. More on that in a moment.
What’s being discussed now is a potential shift that would move certain peptides into “Category 1,” which would allow licensed compounding pharmacies to prepare them under a physician’s prescription while they remain under regulatory review. This doesn’t mean they’d be FDA-approved drugs — but it would mean more patients could access them through legitimate medical channels, with appropriate oversight.
I think that’s a good thing. Not because peptides are without risk — they’re not — but because access without oversight is far riskier than access with it.
The Research Peptide Problem
Here’s something I want to address directly, because I know many of you have looked into this or know someone who has: a significant number of people are currently sourcing peptides from what are called “research chemical” suppliers — websites that sell peptides labeled “not for human use” or “for research use only” to get around regulations.
I understand why. The interest is real. The results people report online are compelling. And when the legitimate medical pathway is blocked, people find another way.
But I want you to understand what you’re actually taking on when you go that route.
Research peptides are not manufactured to pharmaceutical standards. There is no third-party testing requirement, no sterility guarantee, no verification of what’s actually in the vial. Studies have found that a significant percentage of peptides purchased from unregulated online sources are mislabeled, contaminated (including toxic levels of heavy metals), or contain incorrect concentrations. 1 You may be injecting something that is not what it says it is — and you have no way to know.
Beyond the quality issue, there’s the clinical issue. Peptides are not one-size-fits-all. Dosing matters. Timing matters. Your baseline hormones, your metabolic status, your goals — all of it matters. Without a clinical workup, you’re guessing. And some of these compounds, used incorrectly, can suppress your own hormone production, accelerate tissue growth in ways you don’t want, or interact with other therapies you’re on.
This isn’t fear-mongering. It’s just the reality of working with compounds that are biologically active and dose-dependent.
FDA Status: What’s Approved, What’s Off-Label, and What’s Not
One thing that often gets lost in the peptide conversation is that these compounds exist on a spectrum — from fully FDA-approved medications to compounds with strong human data used off-label, to compounds with promising preclinical research but limited human trials. Knowing where something falls on that spectrum matters.
Here is a summary of the peptides that have human clinical data (note, it is short!):
| Peptide | FDA Status | Primary Use in Practice |
| Semaglutide (Ozempic / Wegovy) | FDA-approved | Metabolic health, body composition |
| Tirzepatide (Mounjaro / Zepbound) | FDA-approved | Metabolic health, body composition |
| Sermorelin | FDA-approved (pediatric GH deficiency); off-label in adults | GH support, recovery, sleep, body composition |
| PT-141 / Bremelanotide (Vyleesi) | FDA-approved (premenopausal women); off-label in perimenopause | Sexual desire, libido, body composition post GLP-1 |
| Ipamorelin / CJC-1295 | Not FDA-approved; human clinical data available; not currently available in compounded form | GH pulse stimulation, body composition, recovery |
I include this table not to overwhelm you, but because I think you deserve to know exactly what you’re taking and under what framework. Off-label use of FDA-approved medications is common and well-established in medicine — but it should be disclosed and discussed, not assumed.
How I Actually Use Peptides in Practice
I prescribe peptides. But I do it conservatively, within a full clinical picture, and only when the evidence supports it for a specific patient’s goals.
Here’s what that looks like in practice.
GLP-1 Agonists
You’ve heard of these — semaglutide and tirzepatide are in this class. They’ve become widely known for weight loss, but in my practice I use them as part of a broader metabolic strategy. For patients with insulin resistance, body composition challenges that aren’t responding to lifestyle changes, or significant inflammatory burden, GLP-1s can be a meaningful tool. They work best when paired with a nutrition strategy that preserves lean mass, adequate protein intake, and resistance training. I don’t prescribe them without that framework in place.
Sermorelin
Sermorelin is a growth hormone-releasing hormone (GHRH) analogue. Rather than replacing growth hormone directly, it stimulates your pituitary gland to produce more of its own. This is an important distinction. I prefer this approach over exogenous growth hormone for most patients because it works with your body’s own feedback loops rather than bypassing them.
I use sermorelin primarily for patients with documented low IGF-1, poor sleep quality, slow recovery from training, or age-related body composition changes. It’s not appropriate for everyone — it requires baseline labs, and it’s not something I prescribe without a clear clinical rationale.
PT-141 (Bremelanotide)
PT-141 is a melanocortin receptor agonist that works centrally — meaning it acts on the brain rather than on blood vessels — to support sexual function and libido. It’s FDA-approved under the brand name Vyleesi for hypoactive sexual desire disorder in premenopausal women, and I use it off-label in perimenopausal patients where hormonal optimization alone hasn’t fully addressed this. 2 It’s one of the few options available for hypoactive sexual desire, which is a real and underaddressed issue. I use it selectively, always in the context of a full hormone panel.
There’s also emerging data suggesting bremelanotide may play a role beyond libido. 3 In a Phase 2 trial published in March 2025, low-dose bremelanotide co-administered with tirzepatide not only enhanced weight loss synergistically — it also appeared to halt the rapid weight regain that typically follows GLP-1 discontinuation. Body composition data from that trial is still being analyzed, but the mechanism makes sense: MC4R agonism influences energy homeostasis at the hypothalamic level, which is a different pathway than GLP-1 acts on. This is early-stage data but it’s one of the more interesting signals in the obesity and metabolic medicine space right now.
Ipamorelin / CJC-1295
Ipamorelin is a growth hormone secretagogue — it stimulates the pituitary to release GH in a pulsatile, physiologic way. CJC-1295 is a GHRH analogue that extends the duration of that effect. Together, they’re one of the more well-studied peptide combinations for body composition, recovery, and sleep quality, with human clinical data supporting their use. 4, 5
I want to be transparent: ipamorelin and CJC-1295 are not currently available through licensed compounding pharmacies in the U.S. under current regulations. I’m including them here because the regulatory landscape is actively shifting, and they may become accessible through legitimate medical channels. When and if that changes, this is a combination I’d consider for the right patients — particularly athletes and active individuals focused on recovery and body composition.
My Clinical Philosophy on Peptides
I want to be straightforward with you: peptides are not magic. They are tools. And like any tool, their value depends entirely on whether you’re using the right one, at the right dose, for the right reason, in the right person.
My approach is:
Test first. I don’t prescribe peptides without understanding your baseline — hormones, inflammatory markers, metabolic function, body composition. The peptide should address something specific that we can measure.
Start low. I use conservative dosing, especially at the start. The goal is to see how your body responds before making adjustments.
Layer, don’t lead. Peptides work best when the foundations are already in place — sleep, nutrition, movement. They’re adjuncts, not replacements for those things.
Monitor. We track how you’re responding — through labs, symptoms, and your subjective experience. If something isn’t working or isn’t appropriate, we stop.
Source matters. Everything I prescribe comes from NABP-accredited compounding pharmacies that meet U.S. Pharmacopeia standards. This is non-negotiable.
Is This Right for You?
Peptides are not appropriate for everyone, and they’re not the first thing I reach for. But for the right patient — someone who has a clear clinical picture and specific goals that align with what these compounds can do — they can be a meaningful part of a precision medicine plan.
If you’re curious whether peptides might be relevant to your care, the best place to start is a Wellness Evaluation. That’s where we look at your full picture — labs, history, goals — and figure out what’s actually driving your symptoms and what tools make sense for you.
A Note on What’s Coming
I’m watching the regulatory landscape closely. If access to additional peptides expands through legitimate medical channels, I’ll evaluate each one the same way I evaluate everything: Is there evidence? Is it safe? Is it appropriate for the patients I work with? If the answer is yes, I’ll offer it. If it’s not, I won’t.
I’ll keep you updated as this space evolves.
Dr. Ashley Shrader is a doctorate-prepared nurse practitioner and IFMCP-certified functional medicine provider. She is the founder of Rise Functional Medicine, a telehealth practice specializing in hormones, gut health, and brain optimization.
References
- Janvier, S., Cheyns, K., Canfyn, M., Goscinny, S., De Spiegeleer, B., Vanhee, C., & Deconinck, E. (2018). Impurity profiling of the most frequently encountered falsified polypeptide drugs on the Belgian market. Talanta, 188, 795–807. https://doi.org/10.1016/j.talanta.2018.06.023
- Kingsberg, S. A., Clayton, A. H., Portman, D., Williams, L. A., Krop, J., Jordan, R., Lucas, J., & Simon, J. A. (2019). Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and gynecology, 134(5), 899–908. https://doi.org/10.1097/AOG.0000000000003500
- https://www.prnewswire.com/news-releases/palatin-announces-mc4r-agonist-bremelanotide-co-administered-with-glp-1gip-tirzepatide-meets-primary-endpoint-in-phase-2-obesity-study-302414708.html
- Gobburu, J. V., Agersø, H., Jusko, W. J., & Ynddal, L. (1999). Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharmaceutical research, 16(9), 1412–1416. https://doi.org/10.1023/a:1018955126402
- Sackmann-Sala, L., Ding, J., Frohman, L. A., & Kopchick, J. J. (2009). Activation of the GH/IGF-1 axis by CJC-1295, a long-acting GHRH analog, results in serum protein profile changes in normal adult subjects. Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society, 19(6), 471–477. https://doi.org/10.1016/j.ghir.2009.03.001
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