Sermorelin

Human evidence can mean a controlled clinical study, an observational study, a safety or exposure report, or evidence from a particular finished formulation. Those are different kinds of information.

Limited human evidence. Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population.

Preclinical means research in cells, tissues, or animals rather than in people. It can help researchers form a hypothesis, but it cannot establish a human benefit or a complete human safety profile.

Development relied on the known physiology of GHRH receptor stimulation and preapproval pharmacology. Mechanistic hormone release does not establish a clinical benefit for current unapproved uses.[2]

Preclinical findings do not establish outcomes in people.

Risk information may describe the compound, a finished product, a route, a population, or product-quality concerns. The cited material does not replace a current product label or an individual professional assessment.

This section is about the United States only. Status applies to a product, formulation, route, population, and use—not to a name in the abstract. A status shown here is not a recommendation or a statement about another country.

• Source/status dateJul 22, 2026

  Research only

  Geref approvals were withdrawn effective June 18, 2009 at the sponsor's request. FDA determined they were not withdrawn for safety or effectiveness reasons, but no current FDA-approved sermorelin product was identified.

  Specific product form or route is not separately published in this status record.

  Open source context

The date above is the date attached to the published status record or source context. It is not necessarily the original approval date.

These prompts help organise a conversation with a qualified professional. They do not create a treatment recommendation, dose, or protocol.

• EvidenceWhich human evidence applies to the exact product, form, route, and use being discussed?
• What remains uncertainWhat is known, and what remains uncertain for this specific context?
• RisksWhich important warnings, common effects, and product-quality concerns should be discussed?
• U.S. statusWhat does the U.S. status cover, and what does it not cover?

Related means that the profiles share a topic, pathway, product context, or research question. It does not mean that they are equivalent.

• CJC-1295 with DACBoth engage growth-hormone-releasing pathways but have different identities, histories, and evidence.

PeptideGrid review date: Jul 22, 2026. Sources support the specific sections that cite them. Publication does not imply endorsement, equivalence, or individual suitability.

1. 1

   FDA determination for withdrawn Geref approvals

   U.S. Food and Drug Administration. Determination That Geref (Sermorelin Acetate) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 FR 14095. 2013.

   U.S. Food and Drug Administration · Published Mar 4, 2013 · Accessed Jul 22, 2026 · Regulatory source

   Open source
2. 2

   FDA approval package for Geref sermorelin acetate

   U.S. Food and Drug Administration. Geref (sermorelin acetate for injection) NDA 19-863 approval package.

   U.S. Food and Drug Administration · Accessed Jul 22, 2026 · Regulatory source

   Open source
3. 3

   FDA information about compounded drugs

   U.S. Food and Drug Administration. Consumer and Health Care Professional Information about Compounded Drugs.

   U.S. Food and Drug Administration · Accessed Jul 22, 2026 · Regulatory source

   Open source