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Peptide therapy

Sermorelin (sermorelin acetate): what to know

Medical review pending · Last updated

Regulatory status: Compoundable by licensed 503A pharmacies. Sermorelin was the active ingredient in Geref®, an FDA-approved drug withdrawn from sale for commercial reasons (FDA determined in 2013 it was not withdrawn for safety or effectiveness). Licensed 503A pharmacies may compound it for an individual patient prescription. Compounded sermorelin is not FDA-approved, and its effectiveness for anti-aging or body-composition goals has not been established by FDA.

What is Sermorelin?

Sermorelin is a 29-amino-acid fragment of growth hormone-releasing hormone. Rather than supplying growth hormone directly, it signals the pituitary gland to release growth hormone in its natural pulses.

Who it may be for

Adults whose provider is evaluating low growth hormone-related concerns after history, exam, and labs. It is not appropriate for everyone, including people with active cancer or certain pituitary conditions.

How it is given

Subcutaneous injection, if prescribed.

Safety considerations

Any prescription is at the sole discretion of a licensed provider after evaluation. Metabcore does not make claims that Sermorelin treats, cures, or prevents any disease beyond FDA-approved labeling.

Frequently asked questions

Is sermorelin FDA-approved?

No current sermorelin product is FDA-approved. The original approved product (Geref) was discontinued for business reasons, and compounded sermorelin is not FDA-approved.

Is sermorelin the same as growth hormone?

No. Sermorelin is a GHRH analog that signals your pituitary to release growth hormone; it is not growth hormone itself.

Sources

  1. Federal Register: FDA determination that Geref (sermorelin acetate) was not withdrawn for safety or effectiveness (Mar 4, 2013)
  2. FDA: Bulk drug substances used in compounding (503A and 503B rules)
  3. FDA: Compounding and the FDA, questions and answers

Sources are listed for reference and do not imply endorsement. Regulatory status can change; check the date above.

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