Home / Peptide approval status explained: approved, discontinued, compounded, investigational
Prepared by: Research Desk. Sources are linked for verification.
Every Peptide Infinity entry opens with a status badge. This reference page defines each badge, explains the U.S. regulatory concept behind it, and gives a worked example. Statuses are dated because they change.
Contents
The five status labels
Badge
Meaning
Where we verify it
Approved
At least one product containing the peptide is FDA-approved for a specific use and is currently marketed
Drugs@FDA
Approved – discontinued
An approved product existed but is no longer marketed
Drugs@FDA marketing status
Compounding: under review / restricted
No approved product. Its eligibility for pharmacy compounding is being evaluated, or FDA has raised concerns
FDA compounding pages and advisory committee records
Investigational
Being studied in registered clinical trials; not approved for any use
ClinicalTrials.gov
Unapproved / no recognized status
Not approved, not in active registered development, and sold mainly as “research chemicals”
Absence from all of the above
Approved
“Approved” in an entry always refers to a specific product and use. It does not mean the molecule is approved for anything at all.
Worked example: tesamorelin. Drugs@FDA lists Egrifta (tesamorelin acetate). It is marketed by Theratechnologies under application 022505 and has prescription marketing status. Drugs@FDA notes that this former NDA “was deemed to be a BLA on March 23, 2020” [1]. Its approved use is to reduce excess abdominal fat in adults with HIV and lipodystrophy. A 2024 paper describes it as the only FDA-approved option for abdominal fat accumulation in people with HIV [2]. Using it for anything else, such as general fat loss or “anti-aging”, is off-label.
(Egrifta is a trademark of its owner. We name it only to identify the approved product.)
Approved – discontinued
A product can be approved and later withdrawn from the market. Drugs@FDA records whether FDA has determined that the withdrawal was, or was not, for safety or effectiveness reasons. That determination matters for generics and compounding.
Worked example: sermorelin. Drugs@FDA lists Geref (sermorelin acetate) under NDA 019863 (EMD Serono) as discontinued. It carries the annotation “Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons” [3]. Sermorelin was historically used both as a diagnostic test for growth hormone deficiency and in some children with idiopathic growth hormone deficiency [4].
So the correct badge for sermorelin is Approved – discontinued. There’s no currently marketed FDA-approved sermorelin product. Compounding by pharmacies is a separate legal pathway.
Compounding: under review or restricted
Compounded drugs are prepared by licensed pharmacies or outsourcing facilities. They are not FDA-approved. Under section 503A, compounders may generally use only bulk substances that meet set criteria, for example being the subject of a USP monograph or a component of an approved drug, or appearing on FDA’s 503A bulks list [5]. FDA evaluates nominated substances, sometimes with advice from the Pharmacy Compounding Advisory Committee (PCAC) [6].
Worked example: ipamorelin. Ipamorelin is a selective growth hormone secretagogue and ghrelin-receptor agonist. Its published research includes rodent studies, for example in a rodent model of postoperative ileus [7]. It has no FDA-approved product. Its eligibility for compounding falls under FDA’s bulk-substance framework [5]. Each entry links to the specific FDA record we used and the date we checked it.
Investigational
“Investigational” means the peptide is in registered clinical development. Examples are retatrutide and survodutide in obesity. These products are legally available only through clinical trials or FDA’s expanded access pathway. Investigational entries link to their ClinicalTrials.gov records.
Unapproved / no recognized status
Many peptides discussed online have neither an approved product nor active registered trials. Most are sold as “research use only” chemicals. The badge doesn’t mean “illegal to possess”. That depends on jurisdiction, and we don’t give legal advice. It does mean no regulator has reviewed the product’s quality, safety or effectiveness.
Why we date every status
Peptide regulation is moving quickly. In July 2026 alone, FDA’s compounding advisory committee met to discuss seven peptide-related bulk substances [6]. Each entry shows a “status checked” date, and we re-verify entries when we learn of a regulatory change.
Outside the U.S.
Badges reflect U.S. FDA status unless an entry says otherwise. Health Canada, the EMA and other regulators may differ.
Status framework last updated: 18 October 2026.
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Not medical advice. This page reports published research and regulatory records for information only.