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Somavert

(Pegvisomant)

Phase 3Small molecule

PPharmacia and Upjohn

Pegvisomant is used to treat acromegaly, a condition where the body produces too much growth hormone, causing abnormal growth of hands, feet, and facial features. It works by blocking the effects of growth hormone in the body.[1] Somavert is currently being investigated across 7 indications[3], with its most advanced program in Phase 3.[1]

Somavert is one of 120 small molecule programs targeting Insulin resistance. It is currently in Phase 3.

7

Indications

25

Total Trials

1

Active Trials

119

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Insulin ResistanceActive, not recruiting

Polyostotic Fibrous DysplasiaActive, not recruiting

Mccune-Albright SyndromeActive, not recruiting

AcromegalyUnknown

Growth Hormone DeficiencyActive, not recruiting

Pituitary Gland DiseaseActive, not recruiting

GrowthActive, not recruiting

Insulin ResistancePhase 2

Active, not recruiting

Polyostotic Fibrous DysplasiaPhase 3

Active, not recruiting

Mccune-Albright SyndromePhase 3

Active, not recruiting

AcromegalyPreclinical

Unknown

Growth Hormone DeficiencyPreclinical

Active, not recruiting

Pituitary Gland DiseasePhase 3

Active, not recruiting

GrowthPhase 3

Active, not recruiting

Competition

Competitive Landscape

364 competitors in Growth

#DrugCompanyPhaseTrials

Somavert

PPharmacia and Upjohn

Genotropin

Lovenox

Aricept

Lenvima

Zolymbus

Herceptin

OOrganon and Co

Somavaratan

EGRIFTA WR

TTheratechnologies

Glucophage

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 2Recruiting

Insulin Resistance

NCT05470504

Clinical

Trials by Indication[1]

Acromegaly7 trials

Acromegaly Combination Treatment Study

Terminated·—·N/A·NCT01538966·76 enrolled

A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Completed· Pfizer logo

Pfizer·Phase 4·NCT00068042·100 enrolled

Changes of Left Ventricular Mass and Cardiac Function in Patients With Active Acromegaly During Treatment With the Growth Hormone Receptor Antagonist Pegvisomant

Unknown status·UUniversity of Wuerzburg·Phase 4·NCT00552851·4 enrolled

Show 4 more trials

Strict IGF-1 Control in Acromegaly

Completed·UUnity Health Toronto·Phase 3·NCT02952885·10 enrolled

Acute Application of Pegvisomant and Octreotide in Acromegaly

Completed·LLudwig-Maximilians - University of Munich·Phase 4·NCT00595140·10 enrolled

Bone MicroArchitecture in Acromegaly

Completed·—··NCT03225040·77 enrolled

Pasireotide LAR and Pegvisomant Study in Acromegaly

Unknown status·EErasmus Medical Center·Phase 4·NCT02668172·60 enrolled

Growth5 trials

The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons

Unknown status·HHerlev Hospital·N/A·NCT00969644·12 enrolled

Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes

Completed·UUniversity of California, San Francisco·Phase 2·NCT02023918·6 enrolled

Effect of DPP4 Inhibition on Growth Hormone Secretion

Completed·VVanderbilt University·Phase 4·NCT01701973·44 enrolled

Show 2 more trials

Growth Hormone Signaling in Vivo in Humans

Completed·UUniversity of Aarhus·N/A·NCT00512473·8 enrolled

Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT03882034·12 enrolled

Insulin Sensitivity1 trial

Substrate Metabolism, Growth Hormone Signaling, and Insulin Sensitivity During Fasting

Completed·UUniversity of Aarhus·N/A·NCT02500095·10 enrolled

Quality of Life1 trial

Change in Quality of Life After Addition of Weekly 40 mg Pegvisomant/Placebo in Controlled Acromegalic Patients

Completed·EErasmus Medical Center·Phase 4·NCT00642720·20 enrolled

McCune-Albright syndrome1 trial

A Study of the Effects of Pegvisomant on Growth Hormone Excess in McCune-Albright Syndrome

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 3·NCT00017927·10 enrolled

9 more indications

Biomarker1 trial

Tissue Biomarker for Pegvisomant Action

Completed·—·N/A·NCT01261000·8 enrolled

Efficacy and Safety1 trial

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

Completed· Novartis logo

Novartis·Phase 4·NCT01278342·70 enrolled

Statin1 trial

Pegvisomant And Sandostatin LAR Combination Study

Completed· Pfizer logo

Pfizer·Phase 4·NCT00068029·75 enrolled

Combination Therapy1 trial

Lanreotide Autogel and Pegvisomant Combination Therapy in Acromegalic Patients

Completed· Ipsen logo

Ipsen·Phase 3·NCT00383708·125 enrolled

Growth Hormone Deficiency1 trial

Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency

Unknown status·OOregon Health and Science University·N/A·NCT01804413·10 enrolled

Advanced Solid Tumors1 trial

Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1·NCT00976508·24 enrolled

Insulin resistance1 trial

Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance

Recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT05470504·25 enrolled

Treatment1 trial

Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

Completed·UUniversity of Aarhus·N/A·NCT00652379·18 enrolled

Unspecified2 trials

Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01181973·14 enrolled

Long Term Study With B2036-PEG

Completed· Pfizer logo

Pfizer·Phase 3·NCT00143416·16 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 25, 2003

SOMAVERT

BLA BLA021106

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Pegvisomant. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Pegvisomant compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Pegvisomant. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA021106). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pharmacia and Upjohn company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Growth Hormone Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: PPharmacia and Upjohn

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