Is Sermorelin Safe? What the FDA Really Says About This Peptide

{{primary-cta}}

‍

How Sermorelin Works in the Body

Sermorelin works as a synthetic version of growth hormone-releasing hormone (GHRH). Scientists created it using the first 29 amino acids of natural human GHRH. Many clinicians consider it a potential option alongside direct hormone replacement therapies. But it still carries risks and may not be safe for everyone.

‍

GHRH Mimicry and Pituitary Stimulation

Your anterior pituitary gland contains special cells called somatotrophs. Sermorelin attaches to specific GHRH receptors on these cells and copies your body's natural GHRH action. This attachment triggers a chain of cellular events that cause these cells to produce and release human growth hormone (HGH) into your blood.

Sermorelin signals the pituitary gland through a stimulatory G protein (Gs), which acts like an “on switch” in pituitary cells, telling them to release more growth hormone. While other growth hormone secretagogues work through the ghrelin receptor pathway, sermorelin directly affects the hypothalamic-pituitary-somatotropic axis.

Your pituitary reserve gets a boost because sermorelin does more than just trigger immediate human growth hormone (HGH) release. It also helps create HGH messenger RNA through gene transcription. This helps support the growth hormone neuroendocrine axis, which typically declines first as we age.

‍

Pulsatile HGH Release vs Constant Exposure

Sermorelin differs from direct HGH supplementation in how it releases hormones. Your body maintains its natural rhythm of growth hormone release rather than constantly maintaining high levels. This rhythmic release happens mostly during sleep and when your body needs it.

Research shows that sermorelin treatment can double the average 12-hour HGH release without changing how high or often the peaks occur. It extends the duration of rhythmic HGH release while keeping blood levels within normal ranges.

This pulsing pattern matters because it lets natural feedback systems, especially somatostatin (growth hormone-inhibiting hormone), control HGH production. So, the intact feedback loop helps reduce (but doesn’t eliminate) the risk of excessively high HGH levels. Sermorelin use should always be under the direction of a licensed physician.

‍

Comparison with Recombinant HGH Therapy

Sermorelin and recombinant HGH both raise growth hormone levels, but they work quite differently:

• Stimulation vs. Replacement: Sermorelin encourages your body’s natural HGH production, while recombinant HGH adds synthetic hormones directly to your blood.
• Regulatory Control: Your body’s natural feedback systems work with sermorelin to help prevent excess hormone production. Direct HGH supplementation bypasses these controls and may create higher-than-normal hormone levels.
• Long-term Pituitary Function: Sermorelin may help support pituitary function over time, whereas direct HGH can suppress your body’s growth hormone production through its negative feedback system.
• Safety Profile: Sermorelin therapy may have different side effects than recombinant HGH, partially because it maintains the body’s natural hormone pulses and feedback systems. However, both approaches can cause side effects, and neither is risk-free. Direct HGH carries different risks since levels can go beyond normal ranges.

Sermorelin works with your body’s systems rather than overriding them. This may help explain why clinicians consider it an alternative to direct HGH therapy despite its current FDA approval status.

‍

{{primary-cta}}

‍

FDA Approval History and Discontinuation

Sermorelin acetate’s drug history with the FDA—from obtaining orphan drug status to leaving the market—helps explain how regulators have viewed its safety.

Original FDA Approval for Pediatric Growth Hormone Deficiency

The FDA's relationship with sermorelin started in 1988. The agency designated it as an orphan drug "to treat idiopathic or organic growth hormone deficiency in children with growth failure.” The FDA then approved sermorelin through two separate applications:

• In December 1990, the FDA approved sermorelin injection (0.05 mg base/amp) under NDA 19-863. Doctors used it to check the pituitary gland's ability to make growth hormone.
• The FDA took a bigger step on September 26, 1997. They approved sermorelin acetate injection (0.5 mg base/vial and 1.0 mg base/vial) under NDA 20-443. The brand name Geref® treated children with idiopathic growth hormone deficiency (GHD) who had growth failure.

This approval confirmed sermorelin's mechanism of action and demonstrated that it was a legitimate medical treatment. The FDA approved it specifically for children with healthy pituitary glands who needed additional stimulation to produce enough growth hormone.

‍

Voluntary Withdrawal by Manufacturer in 2008

EMD Serono decided to stop manufacturing Geref® even though it was approved. The company sent a letter to the FDA on December 2, 2008. They announced they would stop manufacturing GEREF® (sermorelin Acetate) injection and requested the withdrawal of NDA 20-443. The FDA then moved the product to its "Discontinued Drug Product List" in the Orange Book.

Money, not safety, drove this decision. Recombinant human growth hormone (rhGH) became the standard treatment for children with GHD, and sermorelin’s market shrank as a result. Any potential benefits in adults didn’t change the fact that its FDA approval was only for pediatric use.

Children with serious growth problems needed more potent doses of growth hormone. Direct rhGH injections worked better than stimulating their pituitary gland. EMD Serono ultimately decided that manufacturing sermorelin no longer made business sense.

‍

Not Banned for Safety Reasons

The difference between drugs withdrawn for safety reasons and those discontinued for business reasons really matters. On May 19, 2009, the FDA announced that both sermorelin NDAs would be withdrawn effective June 18, 2009. However, the notice didn’t cite safety or effectiveness concerns as the reason for withdrawal.

The FDA echoed this sentiment in 2013, stating that the “FDA has determined under § 314.161 that GEREF (sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn for reasons of safety or effectiveness."

‍

Is Sermorelin Legal Today?

People may wonder if sermorelin is legal, given that the manufacturers discontinued the commercial version. Let’s get into its current regulatory position and availability.

Current Status of FDA Approval

Sermorelin no longer has FDA approval for any use. EMD Serono voluntarily discontinued production in 2008, and the FDA now lists it as a “discontinued drug product.” This doesn’t mean sermorelin is banned or automatically unsafe. The FDA specifically stated that Geref (sermorelin acetate) was not withdrawn for safety or effectiveness reasons, which is why it can still be prescribed and compounded by compounding pharmacies rather than sold as an FDA-approved drug.

Compounded Use in Licensed Pharmacies

Licensed compounding pharmacies now provide sermorelin in customized medications per individual prescriptions. The FDA doesn’t review compounded medications for safety, effectiveness, or quality. Patients should work with reputable compounding facilities that follow strict quality control standards. Compounded sermorelin products are not FDA-approved.

‍

Is Sermorelin FDA-approved for Adults?

The FDA never approved sermorelin for use in adults. The original approval focused on the diagnosis and treatment of pediatric growth hormone deficiency. Sermorelin never received formal FDA approval to treat adult growth hormone deficiency or for anti-aging purposes. Doctors now prescribe it off-label for adult hormone therapy based on their clinical judgment despite the lack of adult-specific approval.

‍

Legal Off-Label Use in Hormone Clinics

Doctors can legally prescribe medications off-label for uses beyond their FDA-approved indications. Sermorelin is different from rhGH, which has strict federal restrictions on approved conditions. Sermorelin isn’t a controlled substance, which means licensed physicians can prescribe it legally when clinically appropriate and consistent with federal and state law. Athletes should also know that many sports organizations ban sermorelin as a performance-enhancing substance.

In summary, sermorelin has a unique legal position. While it’s no longer FDA-approved, you can still get it legally through proper medical channels with a valid prescription. That said, legal availability doesn’t guarantee it’s suitable or safe for every patient.

‍

{{primary-cta}}

‍

Safety Profile and Known Side Effects

Like all hormone-related therapies, sermorelin can cause side effects and may not be appropriate for everyone. 

Injection Site Reactions and Systemic Effects

Most people who use sermorelin feel minor discomfort where they inject it. Pain, redness, or swelling are common reactions at the injection site. These local effects often go away quickly without medical help. Some patients might feel mild itching, though this rarely happens.

The body can also show wider reactions. Headaches, dizziness, facial flushing, and sleepiness are common. Patients have reported nausea, trouble swallowing, and changes in taste. These side effects usually fade as your body gets used to the treatment. But you should still tell your clinician about any symptoms you notice.

Overstimulation Risks and Hormonal Imbalance

Your body might become less responsive to sermorelin if you use it too long without appropriate breaks. This can make the peptide less effective over time. Using too much could lead to fluid retention, joint pain, or mood swings.

Sermorelin affects your hormone system, so watching your heart health becomes crucial. People with heart conditions need extra care since the therapy can affect blood pressure and heart function. Long-term use might also change how your body processes glucose.

Drug Interactions: Levothyroxine, Prednisone, and Insulin

Sermorelin can interact with several different medications. The main ones are:

• Thyroid medications (levothyroxine): These might affect how well sermorelin works or change thyroid function.
• Glucocorticoids (prednisone): These can block sermorelin's effects.
• Insulin: This might hide symptoms like tiredness or swelling.

Aspirin and atropine are other medications that can interact with sermorelin. If you have diabetes or thyroid issues, tell your doctor about all your medications before starting treatment.

‍

Why Compounding Pharmacy Standards Matter

The standards of the pharmacy preparing sermorelin determine its quality, purity, and sterility. Reputable compounding pharmacies must follow strict state and federal regulations to ensure product safety and accurate formulation. These responsible compounders get pharmaceutical-grade active pharmaceutical ingredients (APIs) from manufacturers that meet FDA criteria. Additionally, the pharmacy must have proper licensing through your state board of pharmacy.

Legitimate pharmacies provide appropriate certification information and work with qualified healthcare practitioners while maintaining strict quality standards.

‍

Conclusion

Sermorelin is a different way to support growth hormone that works with your body's natural systems. The FDA withdrew its approval in 2008, but this was a business decision rather than a safety issue. The peptide remains available through licensed compounding pharmacies if you have a valid prescription. Because compounded sermorelin is not FDA-approved and has not been reviewed for safety, effectiveness, or quality, careful sourcing and medical oversight are essential.

This peptide is different from direct HGH supplements in several ways. Your body’s normal feedback controls stay in place, while your pituitary gland releases growth hormone in natural on-and-off pulses. This physiologic pattern may influence the type and timing of side effects compared to recombinant HGH, but neither option is guaranteed to have fewer or milder risks for every person.

Side effects are often mild for many patients but can be serious occasionally with sermorelin. You might notice injection site reactions, headaches, or brief dizziness. These symptoms may fade as your body adapts to treatment. But, persistent or severe symptoms should be reviewed with your clinician. 

Sermorelin sits in a unique legal space with no FDA approval yet it’s still available through proper medical channels. Your peptide therapy should start and continue with qualified medical guidance to help balance potential benefits and risks for your specific health situation.

‍