Is Sermorelin FDA Approved? (What Uses Does it Have Approval For?)

What is Sermorelin?

Sermorelin is a synthetic form of growth hormone-releasing hormone used to diagnose and treat growth hormone deficiency in children, and sometimes off-label to treat hormone growth deficiency in adults. Sermorelin may support healthy growth hormone levels, increase growth hormone levels, improve overall well being and vitality, and may support muscle enhancement. Specifically, it's composed of 29 amino acids that correspond to the amino-terminal segment of human GHRH ^[4].

Sermorelin may work by binding to specific receptors on the pituitary gland, stimulating the natural production and secretion of human Growth Hormone (hGH) ^[5]. 

The medication may be prescribed by a licensed healthcare provider to be typically administered via subcutaneous injection once daily, preferably at night to align with the body's natural hormone production patterns ^[6]. This timing may help optimize the treatment's effectiveness while maintaining physiological hormone patterns.

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Sermorelin FDA Approval Status

The regulatory history of sermorelin presents an interesting timeline of FDA oversight and approval changes. Initially, the FDA granted sermorelin acetate orphan drug designation in 1988 for treating idiopathic or organic growth hormone deficiency in children with growth failure ^[1].

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The medication's FDA approval journey includes several key developments:

• Original FDA approval under the trade name Geref®
• Clinical implementation for growth hormone deficiency
• Manufacturer discontinuation ^[2]
• Removal from FDA-approved status in 2004 ^[8]

Currently, sermorelin acetate is not available as an FDA-approved product ^[2]. Side effects of sermorelin include allergic reactions, injection site reactions, headaches, nausea, dizziness, and muscle loss resulting in fatigue. Other side-effects may include overstimulation of growth hormone and cardiovascular and metabolic concerns.

Consult with a licensed healthcare provider to determine whether or not sermorelin is an option for you. 

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Sermorelin Uses

It is primarily used to stimulate the release of human growth hormone (HGH) from the pituitary gland. Its applications span both medical and non-medical contexts:

Medical Uses

1. Growth Hormone Deficiency in Children:
   • Used to treat children with growth hormone deficiencies, helping to promote growth and development.
2. Adult Growth Hormone Deficiency (AGHD):
   • In adults, it can be used to address conditions associated with low HGH levels, such as fatigue, decreased muscle mass, or poor quality of life.
3. Support for Hypothalamic or Pituitary Dysfunction:
   • Helps in cases where the hypothalamus or pituitary gland is under-functioning but can still respond to stimulation.

Non-Medical and Anti-Aging Uses (Often Off-Label)

1. Potentially Anti-Aging:
   • Popular in anti-aging therapies, sermorelin could improve skin elasticity, reduce wrinkles, and enhance overall vitality.
2. Potential Muscle Growth and Fat Reduction:
   • Often used by individuals seeking to increase lean muscle mass, enhance physical performance, and reduce body fat.
3. Potential Improved Sleep:
   • Sermorelin may enhance sleep quality, which is critical for HGH release and overall health.
4. Potential Enhanced Recovery and Energy:
   • Used for better recovery from workouts, injuries, or surgeries, and to increase energy levels.
5. Potential Immune System Support:
   • Can contribute to improved immune function and resilience against illnesses.

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How is Sermorelin Available? 

Sermorelin must be prescribed by a licensed healthcare provider post consultation and is a prescription-only medication. 

Athletes should exercise particular caution, as sermorelin remains banned by most sports organizations, similar to other performance-enhancing treatments ^[15].

Sermorelin is currently not FDA-approved in any forms. It may be available in a compounded form acquired via a prescription from a licensed healthcare provider post-consult. Compounded medications are not reviewed by the FDA for safety, effectiveness or quality. 

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Sermorelin Availability

Accessing sermorelin may require following specific protocols and meeting certain eligibility criteria. Patients seeking sermorelin must complete a structured evaluation process that may include:

• Medical history assessment
• Blood test evaluation
• Clinician video consultation
• State residency verification ^[18]
• Consultation with a licensed healthcare provider 

Proper storage is important for maintaining medication efficacy. Sermorelin may require refrigeration at temperatures between 36°F to 46°F (2°C to 8°C) a ^[17]. 

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Final Thoughts

Sermorelin is currently not FDA-approved.

If you are still interested in buying sermorelin, you can do so with Try Eden.

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FAQs:

How safe is sermorelin?

Side effects of allergic reactions, injection site reactions, headaches, nausea, dizziness, and muscle loss resulting in fatigue. Please consult with a licensed healthcare provider to determine whether or not sermorelin is an option for your health journey. Side effects of sermorelin may include allergic reactions, injection site reactions, headaches, nausea, dizziness, and muscle loss resulting in fatigue. Other side-effects may include overstimulation of growth hormone and cardiovascular and metabolic concerns.

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Important Safety Considerations:

• Medical screening required before treatment
• Blood work necessary to determine eligibility
• Regular monitoring throughout therapy ^[21]

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Other side effects may include:

• Difficulty swallowing
• Dizziness
• Headache
• Changes in taste

Patients should undergo comprehensive medical evaluation and provide complete health history before beginning treatment ^[21].

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Disclaimer: The FDA does not approve compounded medications for safety, quality, or manufacturing. Prescriptions and a medical evaluation are required for certain products. The information provided on this blog is for general informational purposes only. It is not intended as a substitute for professional advice from a qualified healthcare professional and should not be relied upon as personal health advice. The information contained in this blog is not meant to diagnose, treat, cure, or prevent any disease. Readers are advised to consult with a qualified healthcare professional for any medical concerns, including side effects. Use of this blog's information is at your own risk. The blog owner is not responsible for any adverse effects or consequences resulting from the use of any suggestions or information provided in this blog.

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References 

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1.

U.S. Food and Drug Administration. Sermorelin Acetate: Search Orphan Drug Designations and Approvals. Accessed December 5, 2024. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=24687

2.

Gianturco SL, Pavlech LL, Storm KD, Mattingly AN, Yuen MV, Yoon S. Sermorelin acetate: Summary Report. Accessed December 5, 2024. https://archive.hshsl.umaryland.edu/bitstream/handle/10713/14877/Sermorelin%20acetateFinal202012.pdf?sequence=1

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Health Gains. Is Sermorelin FDA Approved? Accessed December 5, 2024. https://healthgains.com/faqs/is-sermorelin-fda-approved

4.

Drug Bank. Sermorelin. Accessed December 5, 2024. https://go.drugbank.com/drugs/DB00010

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Wellspring Medical. Hormones/Peptides. Published online March 6, 2024. Accessed December 5, 2024. https://wellspringmedicalspa.com/hormones-peptides

6.

Askinazi O PhD. Sermorelin Therapy Benefits, Uses, Side Effects, Risks, More. Published online August 21, 2023. Accessed December 5, 2024. https://www.healthline.com/health/sermorelin

7.

Walker RF. Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? Clinical interventions in aging. 2006;1(4):307-308. https://pmc.ncbi.nlm.nih.gov/articles/PMC2699646/

8.

Drip Hydration Therapy & Medical Wellness. The Science Behind Sermorelin Side Effects: Is Sermorelin Safe? Published online March 1, 2024. Accessed December 5, 2024. https://driphydration.com/blog/sermorelin-side-effects/?srsltid=AfmBOoo1Vnia8TgoXxpuQ6EYNSRvTmnsOOJdxllmRAzfdgrCtdtbork

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ScienceDirect Topics. Sermorelin - an overview. xPharm: The Comprehensive Pharmacology Reference. https://www.sciencedirect.com/topics/medicine-and-dentistry/sermorelin

10.

HydraMed. Sermorelin’s History & Discovery: A Breakthrough in Peptide Therapy. Published online April 5, 2024. Accessed December 5, 2024. https://hydramed.com/blog/history-of-sermorelin-from-discovery-to-therapeutic-use

11.

Health Gains. What is Sermorelin Good for? Accessed December 5, 2024. https://healthgains.com/hormone-therapy/sermorelin/what-is-sermorelin-good-for

12.

Drip Hydration Therapy & Medical Wellness. The Science Behind Sermorelin Side Effects: Is Sermorelin Safe? Published online March 1, 2024. Accessed December 5, 2024. https://driphydration.com/blog/sermorelin-side-effects/?srsltid=AfmBOorb6Slc2lsdZaW60RFMV4CA6QZFABK7oBV3q377tpt1u2BABDO

13.

Health Gains. Is Sermorelin a Controlled Substance? Accessed December 5, 2024. https://healthgains.com/faqs/is-sermorelin-a-controlled-substance

14.

Drip Hydration Therapy & Medical Wellness. Sermorelin For Athletes: Exploring The Benefits And Legalities In Sports. Published online March 7, 2024. Accessed December 5, 2024. https://driphydration.com/blog/sermorelin-athletes/?srsltid=AfmBOoqnAt1-himAEAW2T4nCgp-prosebQYJyZqm7AgdE4WxYQoo9cj7

15.

Drip Hydration Therapy & Medical Wellness. Sermorelin For Athletes: Exploring The Benefits And Legalities In Sports. Published online March 7, 2024. Accessed December 5, 2024. https://driphydration.com/blog/sermorelin-athletes/?srsltid=AfmBOoocajv028MsIyD215koHnfvHgHhkoGSa8j36jAd-2m-HfWX69R

16.

Reed Smith LLP. FDA removes certain peptide bulk drug substances from Category 2 of interim 503A bulks list and sets dates for PCAC review. Published online October 1, 2024. Accessed December 5, 2024. https://www.reedsmith.com/en/perspectives/2024/10/fda-certain-peptide-bulk-drug-substances-category-2-503a-bulks-pcac

17.

HydraMed. Buy Sermorelin Online : Safe & Effective Growth Hormone Therapy. Accessed December 5, 2024. https://hydramed.com/rx/semorelin/injections

18.

Life Force. Sermorelin. Accessed December 5, 2024. https://www.mylifeforce.com/product/sermorelin?srsltid=AfmBOoqUx9SgQ1dMq1ukF0Yug4BN4j9kDUigCu82neu8gily8TYNriS9

19.

Regen Doctors. Sermorelin Peptide Price. Accessed December 5, 2024. https://regendoctors.com/products/sermorelin-peptide-therapy-2000-mcg

20.

Eden. Sermorelin Prescription Online: Safe, Legal Options Explained. Accessed December 5, 2024. https://www.tryeden.com/post/sermorelin-prescriptions-online-understanding-the-process-and-considerations?srsltid=AfmBOorcG9Uxms5qCdxzaR3oP6U4RuxuIZASqtjdd0K49jjNSFO1JmSK                       

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21.

Health Gains. What Are the Side Effects of Sermorelin? Accessed December 5, 2024. https://healthgains.com/hormone-therapy/sermorelin/what-are-the-side-effects-of-sermorelin

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