At a glance
FDA approval FDA-approved 1 application
Randomized controlled trials 38 of 662 publications on PubMed
Registered clinical trials 41 2 active
Adverse event reports 4,115 2,304 classified as serious
- Pegvisomant is an FDA-approved drug, marketed as Somavert (first approval: March 25, 2003).
- PubMed lists 662 publications mentioning it, including 38 randomized controlled trials and 14 animal-only studies.
- ClinicalTrials.gov lists 41 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 4,115 reports mentioning it; 2,304 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
| BLA021106 | SOMAVERT | Approved, marketed | March 25, 2003 | PHARMACIA |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 662
- Human (MeSH) 555
- Animal only 14
- Clinical trials 75
- Randomized controlled trials 38
- Systematic reviews & meta-analyses 18
- Case reports 68
- Retracted 0
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 41
- Active
- 2
- With posted results
- 10
| Study | Status | Phase | Start |
| Effects of Pasireotide Lar Therapy on Bone Metabolism NCT07179926 Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | — | September 8, 2025 |
| Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance NCT05470504 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Recruiting | Phase 2 | January 23, 2023 |
| The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly NCT06597383 IRCCS San Raffaele | Unknown status | — | November 24, 2023 |
| Korean Regulatory Post Marketing Surveillance for Somavert NCT05131100 Pfizer | Completed | — | July 13, 2022 |
| Growth Hormone as a Model for Reversible Activation of Adipose Tissue Fibrosis NCT04998500 University of Aarhus | Unknown status | N/A | August 1, 2021 |
| PegvisOMant and the Immune SystEm (PROMISE) NCT05069324 University of Roma La Sapienza | Completed | — | July 29, 2020 |
| Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess NCT03882034 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | Phase 3 | October 21, 2019 |
| Strict IGF-1 Control in Acromegaly NCT02952885 Unity Health Toronto | Completed | Phase 3 | July 27, 2017 |
| Bone MicroArchitecture in Acromegaly NCT03225040 Columbia University | Completed | — | August 3, 2016 |
| Lipolytic Effects of GH in Human Subjects in Vivo NCT02782221 University of Aarhus | Completed | N/A | May 30, 2016 |
Show 31 more studies
| Study | Status | Phase | Start |
| Pasireotide LAR and Pegvisomant Study in Acromegaly NCT02668172 Erasmus Medical Center | Unknown status | Phase 4 | Aug 2015 |
| Substrate Metabolism, Growth Hormone Signaling, and Insulin Sensitivity During Fasting NCT02500095 University of Aarhus | Completed | N/A | Jul 2015 |
| Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism? NCT02152124 University Hospital, Ghent | Completed | — | June 1, 2014 |
| Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes NCT02023918 University of California, San Francisco Results posted | Completed | Phase 2 | Jan 2014 |
| A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects NCT01893866 Pfizer | Completed | Phase 1 | Aug 2013 |
| Effect of DPP4 Inhibition on Growth Hormone Secretion NCT01701973 Vanderbilt University Results posted | Completed | Phase 4 | Jan 2013 |
| Acromegaly Treatment Quality of Life Study NCT01732406 Massachusetts General Hospital Results posted | Completed | — | Jan 2013 |
| Acromegaly Combination Treatment Study NCT01538966 Cedars-Sinai Medical Center Results posted | Terminated | N/A | March 29, 2012 |
| Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency NCT01804413 Oregon Health and Science University | Unknown status | N/A | Mar 2011 |
| Tissue Biomarker for Pegvisomant Action NCT01261000 Cedars-Sinai Medical Center Results posted | Completed | N/A | Nov 2010 |
| Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects NCT01181973 Pfizer | Completed | Phase 1 | Oct 2010 |
| Figitumumab Combined With Pegvisomant For Advanced Solid Tumors NCT00976508 Pfizer Results posted | Terminated | Phase 1 | Nov 2009 |
| The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons NCT00969644 Herlev Hospital | Unknown status | N/A | Sep 2009 |
| Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients NCT00652379 University of Aarhus | Completed | N/A | Jun 2008 |
| Acute Application of Pegvisomant and Octreotide in Acromegaly NCT00595140 Ludwig-Maximilians - University of Munich | Completed | Phase 4 | Jan 2008 |
| Long Term Use of Somavert (Pegvisomant) For A Regulatory Post Marketing Commitment Plan NCT00658879 Pfizer Results posted | Completed | — | August 7, 2007 |
| Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients NCT00642720 Erasmus Medical Center | Completed | Phase 4 | Oct 2006 |
| Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients NCT00383708 Ipsen Results posted | Completed | Phase 3 | Oct 2006 |
| Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients NCT01278342 Novartis Pharmaceuticals Results posted | Completed | Phase 4 | Sep 2006 |
| Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content NCT00476879 University of Aarhus | Completed | N/A | Aug 2006 |
| Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant NCT00552851 University of Wuerzburg | Unknown status | Phase 4 | Jun 2006 |
| Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly NCT00376064 Novartis Pharmaceuticals | Completed | Phase 4 | Mar 2006 |
| Cardiac Function and Morphology Evaluated by Magnetic Resonance Imaging in Growth Hormone Deficiency and Acromegaly NCT00970463 Herlev Hospital | Completed | — | Jan 2006 |
| Growth Hormone Signaling in Vivo in Humans NCT00512473 University of Aarhus | Completed | N/A | Sep 2005 |
| Effect of Pegvisomant on GH/IGF-I Relationship in GHD NCT00468624 The Christie NHS Foundation Trust | Terminated | N/A | Dec 2004 |
| Canadian Pegvisomant Compassionate Study In Acromegalic Patients NCT00151437 Pfizer | Completed | Phase 4 | Nov 2004 |
| Long Term Study With B2036-PEG NCT00143416 Pfizer | Completed | Phase 3 | Apr 2004 |
| Non Interventional Study For Patients Treated With Somavert® NCT00858143 Pfizer Results posted | Completed | — | Jan 2004 |
| Pegvisomant And Sandostatin LAR Combination Study NCT00068029 Pfizer | Completed | Phase 4 | Oct 2003 |
| A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly NCT00068042 Pfizer | Completed | Phase 4 | Apr 2003 |
| A Study of the Effects of Pegvisomant on Growth Hormone Excess in McCune-Albright Syndrome NCT00017927 National Institute of Dental and Craniofacial Research (NIDCR) | Completed | Phase 3 | Jun 2001 |
All 41 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 4,115
- Serious
- 2,304
- With death outcome
- 320
Most reported reactions
- Off label use 489
- Drug ineffective 436
- Headache 404
- Fatigue 387
- Insulin-like growth factor increased 379
- Arthralgia 300
- Product dose omission issue 268
- Injection site pain 262
- Diarrhoea 256
- Nausea 232
- Pain 213
- Blood pressure increased 205
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- SOMAVERT HUMAN PRESCRIPTION DRUG Pharmacia & Upjohn Company LLC December 18, 2025
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.