Hormones & metabolism GH receptor antagonist
Pegvisomant
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Pegvisomant (sold as Somavert) is a modified, pegylated version of growth hormone that works as a growth hormone receptor blocker, used to treat acromegaly when other therapies fall short. Rather than suppressing the pituitary, it stops growth hormone from acting at its receptor, which normalizes insulin-like growth factor 1 in the large majority of patients. It has been FDA-approved in the U.S. since 2003 and is given as a daily subcutaneous injection.
At a glance
- What it is
- A pegylated growth hormone receptor antagonist
- Approved for
- Acromegaly inadequately controlled by other treatments
- Key fact
- In a controlled trial, daily dosing normalized IGF-1 in roughly 90% of patients at the higher dose
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Pegvisomant (Somavert) is an FDA-approved growth hormone receptor blocker for acromegaly. Learn how it lowers IGF-1, how it is given, and the research.
What is pegvisomant?
Pegvisomant, sold under the brand Somavert, is a genetically engineered analog of human growth hormone that has been chemically altered and attached to polyethylene glycol (PEG). Unlike the somatostatin analogs that lower growth hormone output from the pituitary, pegvisomant acts at the target: it blocks growth hormone from signaling at its receptor. It was developed from a mutated growth hormone molecule known as B2036 and approved in the United States in 2003.
How does pegvisomant work?
Pegvisomant binds the growth hormone receptor but, because of its engineered substitutions, prevents the receptor from changing shape in the way needed to transmit a signal. Growth hormone normally works by bringing two receptor subunits together; pegvisomant occupies the receptor and blocks that functional pairing, so the downstream production of insulin-like growth factor 1 (IGF-1) in the liver falls. Because the disease activity in acromegaly tracks with IGF-1, lowering it improves symptoms.
A distinctive feature is that pegvisomant works peripherally at the receptor and does not reduce the pituitary tumor's growth hormone output, so measured growth hormone levels actually rise even as IGF-1 normalizes. The PEG attachment extends its half-life to allow once-daily dosing. In a controlled trial, pegvisomant normalized IGF-1 in about 90 percent of patients at the 20 mg daily dose, with symptom improvement.
Is it FDA-approved?
Editor’s note
Status: Yes. Pegvisomant was approved by the FDA in 2003 for acromegaly. It is given as a daily subcutaneous injection, usually starting with a loading dose and then a daily maintenance dose titrated to IGF-1 levels.
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Pegvisomant was approved by the FDA in 2003 for acromegaly. It is given as a daily subcutaneous injection, usually starting with a loading dose and then a daily maintenance dose titrated to IGF-1 levels.
What is pegvisomant prescribed for?
Pegvisomant is prescribed for acromegaly in people who have not responded adequately to surgery, radiation, or other medical therapy, or for whom those options are not appropriate. Because it lowers IGF-1 without shrinking the tumor, patients are monitored with periodic pituitary imaging.
What are the side effects?
According to the prescribing information, common side effects include:
- Injection-site reactions, including fatty lumps (lipohypertrophy)
- Infections, such as cold symptoms
- Pain
- Nausea and diarrhea
- Flu-like symptoms
- Abnormal liver tests
More serious considerations include:
- Elevated liver enzymes and, rarely, liver injury, so liver tests are monitored
- Low blood sugar in people with diabetes, whose medications may need adjustment
- The need to monitor tumor size over time
Sources: FDA prescribing information for Somavert; the controlled pegvisomant trial (Trainer et al., New England Journal of Medicine, 2000, DOI: 10.1056/NEJM200004203421604), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
Compare every peptide’s status in the peptide regulatory status database
More for Hormones & metabolism
View all hormones & metabolism peptides →- FDA-approved Hormones & metabolism
Albiglutide
Albiglutide is a once-weekly GLP-1 receptor agonist made by fusing GLP-1 analog chains to human albumin, approved for type 2 diabetes in 2014 as Tanzeum. It had a somewhat weaker effect on gastric emptying and appetite than some other GLP-1 drugs but showed a cardiovascular benefit in the HARMONY OUTCOMES trial. Despite that, GSK withdrew it from the market in 2018 for commercial reasons, so it remains FDA-approved but is no longer available.
- Not FDA-approved Hormones & metabolism
Compounded-Tesamorelin
Tesamorelin is an FDA-approved growth-hormone-releasing peptide, sold as Egrifta, for excess abdominal fat in HIV-associated lipodystrophy. In a randomized trial of 404 people with HIV (Falutz 2010), visceral fat fell 10.9% on tesamorelin versus 0.6% on placebo over 6 months. Its off-label use for body composition and anti-aging in people without HIV is not an approved indication and lacks dedicated trials. It is banned in sport.
- FDA-approved Hormones & metabolism
Corticotropin
ACTH
Corticotropin (adrenocorticotropic hormone, or ACTH; sold as Acthar Gel and Purified Cortrophin Gel) is a hormone preparation that stimulates the adrenal glands to make their own steroids and also acts directly on immune cells. It is one of the oldest biologic medicines, used today for conditions ranging from infantile spasms to multiple sclerosis relapses. It has been FDA-approved in the U.S. since 1952 and is given as a long-acting injection.
- FDA-approved Hormones & metabolism
Cosyntropin
Cosyntropin (sold as Cortrosyn) is a synthetic fragment of adrenocorticotropic hormone used as a diagnostic agent to test whether the adrenal glands are working. A dose is given and the resulting rise in cortisol shows how well the adrenals respond. It has long been FDA-approved in the U.S. and is given as a single injection during the test.
- FDA-approved Hormones & metabolism
Dulaglutide
Dulaglutide is a once-weekly GLP-1 receptor agonist built by fusing two GLP-1 analog chains to an antibody fragment, which extends its action to about five days. It was approved for type 2 diabetes in 2014 and gained a cardiovascular indication in 2020 after the REWIND trial showed a roughly 12% reduction in major cardiovascular events. It remains on the market as Trulicity.
- In clinical trials Hormones & metabolism
Efpeglenatide
Efpeglenatide is an investigational long-acting GLP-1 receptor agonist, originally developed by Hanmi Pharmaceutical, given as a once-weekly injection for type 2 diabetes and cardiovascular risk. In a large Phase 3 outcomes trial it reduced major cardiovascular events in people with type 2 diabetes. As of 2026, it has not reached approval in major markets.