Pegvisomant

Overview

Pegvisomant is a highly selective growth hormone (GH) receptor antagonist. It is used to treat acromegaly. Unlike dopamine or somatostatin analogs (which inhibit growth hormone secretion), this drug actually blocks the hepatic (GH-mediated) production of insulin like growth factor (IGF-1), which is the main mediator of growth hormone activity.

Indication

Pegvisomant is a growth hormone receptor antagonist used for the treatment of acromegaly.

Associated Conditions

Acromegaly

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance	2022/07/22	NCT05470504	Phase 2	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Korean Regulatory Post Marketing Surveillance for Somavert	2021/11/23	NCT05131100	N/A	Recruiting	Pfizer
Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess	2019/03/20	NCT03882034	Phase 3	Active, not recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bone MicroArchitecture in Acromegaly	2017/07/21	NCT03225040	N/A	Completed	Columbia University
Strict IGF-1 Control in Acromegaly	2016/11/02	NCT02952885	Phase 3	Completed	Unity Health Toronto
Pasireotide LAR and Pegvisomant Study in Acromegaly	2016/01/29	NCT02668172	Phase 4	UNKNOWN	Erasmus Medical Center
Substrate Metabolism, Growth Hormone Signaling, and Insulin Sensitivity During Fasting	2015/07/16	NCT02500095	Not Applicable	Completed	University of Aarhus
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes	2013/12/30	NCT02023918	Phase 2	Completed	University of California, San Francisco
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	2013/07/09	NCT01893866	Phase 1	Completed	Pfizer
Pegvisomant With Glucagon Test to Assess for Adult Growth Hormone Deficiency	2013/03/05	NCT01804413	Not Applicable	UNKNOWN	Oregon Health and Science University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Somavert	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	11/12/2002

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SOMAVERT pegvisomant (rbe) 10mg powder for injection vial and diluent in pre-filled syringe	286628	Pfizer Australia Pty Ltd	Medicine	A	5/31/2017
SOMAVERT pegvisomant (rbe) 15mg powder for injection vial and diluent in pre-filled syringe	286629	Pfizer Australia Pty Ltd	Medicine	A	5/31/2017
SOMAVERT pegvisomant (rbe) 20mg powder for injection vial and diluent in pre-filled syringe	286630	Pfizer Australia Pty Ltd	Medicine	A	5/31/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SOMAVERT	Pfizer Canada Ulc	02272202	Powder For Solution , Kit - Subcutaneous	15 MG / VIAL	1/24/2006
SOMAVERT	Pfizer Canada Ulc	02448831	Kit , Powder For Solution - Subcutaneous	25 MG / VIAL	3/10/2016
SOMAVERT	Pfizer Canada Ulc	02272210	Kit , Powder For Solution - Subcutaneous	20 MG / VIAL	1/24/2006
SOMAVERT	Pfizer Canada Ulc	02272199	Kit , Powder For Solution - Subcutaneous	10 MG / VIAL	1/24/2006
SOMAVERT	Pfizer Canada Ulc	02448858	Powder For Solution , Kit - Subcutaneous	30 MG / VIAL	3/10/2016

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SOMAVERT 25 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	102240010	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
SOMAVERT 20 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	02240003	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
SOMAVERT 30 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	102240012	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
SOMAVERT 15 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	02240002	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
SOMAVERT 10 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	02240001	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
SOMAVERT 20 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Pfizer Europe Ma Eeig	02240004	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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