Understanding Why was Sermorelin taken off the market?

October 12, 2025 •

5 min read

In 2008, Sermorelin, previously known under the brand names Geref and Geref Diagnostic, was voluntarily discontinued by its manufacturer, EMD Serono. The decision to stop commercial production was primarily for business and market-related reasons, not because of safety or effectiveness issues, which is a common misconception surrounding why was Sermorelin taken off the market.

Quick Summary

Sermorelin, a synthetic peptide that stimulates natural growth hormone production, was discontinued by its manufacturer in 2008 due to commercial factors, including manufacturing difficulties and competition from alternative treatments, not safety concerns. Although no longer available as an FDA-approved commercial product, it is still accessible through compounding pharmacies for certain off-label uses.

Key Points

Voluntary Discontinuation: Sermorelin was voluntarily removed from the market by its manufacturer, EMD Serono, in 2008 due to commercial reasons, not safety or efficacy issues.
Not a Safety Issue: The FDA later confirmed that Sermorelin was not withdrawn for reasons of safety or effectiveness, dispelling common myths about its discontinuation.
Market Competition: The emergence of more potent and effective recombinant human growth hormone (rhGH) therapies made Sermorelin less commercially competitive.
Manufacturing Challenges: EMD Serono cited manufacturing difficulties as another factor contributing to the decision to stop production.
Compounded Availability: Though no longer an FDA-approved commercial product, Sermorelin is still available through compounding pharmacies for specific off-label applications with a doctor's prescription.
FDA Confirms Availability Pathway: The FDA has stated that other manufacturers could potentially seek approval for a new Sermorelin product by meeting all legal and regulatory requirements.

The Voluntary Discontinuation: A Business Decision

The most critical aspect of the Sermorelin story is that its withdrawal from the market was a voluntary business decision by the manufacturer, EMD Serono. This was not a forced recall or regulatory action by the U.S. Food and Drug Administration (FDA) due to safety or efficacy problems. The FDA later officially confirmed this, stating the drug was not withdrawn for safety or effectiveness reasons. For patients and healthcare providers, this distinction is crucial, as it contrasts sharply with drugs that are pulled for causing harm or failing clinical trials.

Commercial Viability and Market Dynamics

The voluntary decision stemmed from several commercial pressures that ultimately made continued production unprofitable for the manufacturer. The pharmaceutical landscape had shifted significantly since Sermorelin's initial FDA approval in the 1990s.

Manufacturing Difficulties: The complex process of manufacturing Sermorelin presented ongoing challenges for the company, potentially affecting supply chain reliability and overall cost-effectiveness.
Emergence of Superior Alternatives: Over time, more potent and effective synthetic human growth hormone (HGH) treatments, like recombinant human growth hormone (rhGH), entered the market. These newer therapies offered more predictable results and often required less frequent dosing, making them more attractive to physicians and patients.
High Costs of FDA Maintenance: Maintaining FDA approval for a drug is a costly process, requiring ongoing fees and regulatory oversight. With a narrow and shrinking market share for its pediatric growth hormone deficiency indication, the cost of keeping Sermorelin commercially available no longer justified the potential return on investment.
Limited Approved Use: Sermorelin was approved for a very narrow indication—idiopathic growth hormone deficiency in children. While it was also used off-label, the official market was small, and newer drugs were capturing a larger segment of the overall growth hormone market.

Sermorelin vs. Newer Alternatives

To understand the shift in the market, it is helpful to compare Sermorelin with the recombinant human growth hormone (rhGH) therapies that contributed to its commercial decline. rhGH treatments largely superseded Sermorelin due to perceived advantages in efficacy and ease of use.


Feature	Sermorelin	Recombinant Human Growth Hormone (rhGH)	Tesamorelin (Another GHRH analog)
Mechanism of Action	Stimulates the body's own pituitary gland to produce and release growth hormone.	Directly replaces growth hormone with an exogenous synthetic version.	A stabilized, longer-acting synthetic analog of GHRH.
Efficacy	Often requires higher doses for comparable effectiveness to alternatives, especially in children.	Generally considered more potent and predictable in raising growth hormone levels.	FDA-approved for specific conditions (e.g., HIV-associated lipodystrophy) and may have stronger evidence for certain applications.
Regulatory Status	FDA-approved product discontinued in 2008. Available via compounding pharmacies only.	Widely available as an FDA-approved prescription medication for GHD and other conditions.	FDA-approved for specific indications.
Side Effects	Mimics natural rhythms, potentially leading to fewer side effects associated with high, non-pulsatile HGH levels.	Can cause more significant side effects due to supraphysiological hormone levels.	Side effect profile varies by indication.
Market	Shrunk significantly; now niche market primarily served by compounding pharmacies.	Dominant market share for GHD treatment.	Niche, with its own specific FDA-approved indications.

The Role of Compounding Pharmacies

Although the FDA-approved version of Sermorelin is gone, the drug itself is not illegal. It has found a new life through compounding pharmacies, which can create custom-formulated versions of the drug with a doctor's prescription. This practice raises important regulatory and quality assurance issues:

No FDA Oversight: Compounded drugs, by definition, do not undergo the same rigorous FDA review process as mass-produced, brand-name drugs. The FDA does not verify their safety, effectiveness, or manufacturing quality.
Quality and Purity Risks: Without FDA oversight, there is a greater risk of variations in potency, sterility, and purity. This has occasionally led to voluntary recalls by some compounding pharmacies due to sterility concerns.
Increased Access for Off-Label Use: Compounded Sermorelin is widely used off-label for anti-aging and regenerative medicine purposes, which was not the original FDA-approved use. This has allowed it to continue serving a market need that was not a priority for the commercial manufacturer.

A Complex Regulatory Environment

The FDA's stance on Sermorelin is clear: the drug was not withdrawn for safety or efficacy reasons, and manufacturers are free to re-apply for FDA approval with a new drug application. However, this is a costly and lengthy process that no manufacturer has undertaken since its discontinuation. This leaves the current market for Sermorelin almost entirely in the hands of compounding pharmacies, operating under different regulatory standards.

Conclusion: Sermorelin's Enduring Place in Niche Medicine

The story of why was Sermorelin taken off the market is a fascinating illustration of the intersection of pharmaceutical economics, market evolution, and regulatory pathways. The commercial decisions of its manufacturer, driven by manufacturing issues and superior competition, ultimately ended its run as an FDA-approved medication. However, its continued availability through compounding pharmacies highlights its enduring value for certain clinical applications, albeit within a less regulated framework. For those considering Sermorelin therapy, it is vital to understand this history and consult with a knowledgeable healthcare provider who can explain the differences between the discontinued FDA-approved product and its current compounded alternatives.

For more information on the FDA's decision, you can refer to the official document confirming that Sermorelin was not withdrawn for safety or efficacy reasons.

Note: The content presented is for informational purposes only and is not medical advice. Consult a healthcare professional before starting any new medication or treatment.

Key Factors in Sermorelin's Discontinuation

Voluntary Decision: EMD Serono, the manufacturer, chose to discontinue the drug in 2008 for commercial, not safety, reasons.
Market Competition: The rise of more potent and effective synthetic human growth hormone (HGH) alternatives diminished Sermorelin's market share.
Manufacturing Issues: The manufacturer cited production difficulties that complicated commercial viability.
High Regulatory Costs: The expense of maintaining FDA approval was no longer justified by the drug's limited commercial market.
Reconfirmation of Safety: The FDA later confirmed that the drug was not withdrawn for safety or efficacy reasons.

Sermorelin: Past vs. Present Availability

Historically: Available as a standard, FDA-approved commercial product under brand names Geref and Geref Diagnostic.
Presently: No longer commercially produced, but available through compounding pharmacies with a prescription for off-label uses.

Frequently Asked Questions

No, Sermorelin was not recalled for safety reasons. The manufacturer, EMD Serono, voluntarily discontinued it for commercial reasons in 2008. The FDA later confirmed that the withdrawal was not based on safety or effectiveness issues.

The manufacturer stopped production due to business-related factors. These included manufacturing difficulties, the emergence of more effective and profitable alternatives, and a shrinking market that did not justify the costs of maintaining FDA approval.

Yes, Sermorelin is still available by prescription. However, it is no longer sold as a commercial, FDA-approved product. It must be obtained from a licensed compounding pharmacy, which prepares the medication individually.

The original Sermorelin was an FDA-approved commercial product that underwent strict regulatory review. Compounded Sermorelin is prepared by compounding pharmacies and is not subject to the same level of FDA oversight for safety, purity, and potency as a mass-produced drug.

While many compounding pharmacies are reputable, compounded drugs do not have the same FDA guarantees as commercially produced medications. The FDA does not review compounded products for safety or effectiveness, meaning there can be risks related to sterility, potency, and quality.

Yes, the FDA has indicated that a manufacturer could seek approval for an abbreviated new drug application (ANDA) for Sermorelin. However, the process is expensive, and given the market landscape, no company has done so since its discontinuation.

Newer alternatives for growth hormone therapy include recombinant human growth hormone (rhGH), which directly replaces the hormone, and other GHRH analogs like Tesamorelin, which is FDA-approved for specific conditions.