Drug

Pegvisomant

Approved · EMA

Emerging researchLate-stage development

Also known as Pegvisomant (PEG), Somavert.

RxNorm278739UNIIN824AOU5XV

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase II Study of Growth Hormone Inhibition Using Pegvisomant In Severe Insulin Resistance

Clinical trial2026-05-12Results expected Q1 2028 · ClinicalTrials.gov

An Open-Label Phase 3 Study of the Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess

Clinical trial2025-09-30Completed · ClinicalTrials.gov

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety Profiles of the Co-administration of Lanreotide Autogel 120 mg (Administered Via Deep Subcutaneous Injections Every 28 Days) and Pegvisomant 40 to 120 mg Per Week (Administered Via Subcutaneous Route Once or Twice a Week) in Acromegalic Patients Failing to Respond to Lanreotide Autogel 120 mg Alone

Clinical trial2022-09-27Results posted · ClinicalTrials.gov

Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy

Clinical trial2022-05-20Terminated · ClinicalTrials.gov

Strict IGF-1 Control in Acromegaly (I-Con Study)

Clinical trial2020-05-07Completed · ClinicalTrials.gov

The Effect of Dipeptidyl Peptidase IV Inhibition on Growth Hormone-Mediated Vasodilation

Clinical trial2018-05-29Results posted · ClinicalTrials.gov

Tissue Biomarker for Pegvisomant Action

Clinical trial2017-08-22Results posted · ClinicalTrials.gov

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes

Clinical trial2017-04-24Results posted · ClinicalTrials.gov

An Open-label, Two-step, Multicenter European 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 Not Adequately Controlled by Conventional Regimen

Clinical trial2017-03-03Results posted · ClinicalTrials.gov

Efficacy and Safety of Pasireotide Long Acting Release (LAR) in Combination With Weekly Pegvisomant in Previously Controlled Acromegaly Patients on Combination Treatment of Long-Acting Somatostatin Analogues and Weekly Pegvisomant

Clinical trial2017-03-01Primary completion · ClinicalTrials.gov

Coadministration of lanreotide Autogel and pegvisomant normalizes IGF1 levels and is well tolerated in patients with acromegaly partially controlled by somatostatin analogs alone.

Research2010-12-10European journal of endocrinology

Approval: Somavert (EMA)

Regulatory2002-11-12EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Pegvisomant

Aliases & brands

Pegvisomant (PEG)Somavert

RxNorm CUI

278739

UNII

N824AOU5XV

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2002-11-12

Latest approval

2002-11-12

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2002-11-12Approval

Approval: Somavert (EMA)

Indication: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin… Show full indication

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated. Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF -I concentrations or was not tolerated.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.