Drug

Pegvisomant

As of the edition of 20 October 2026, Pegvisomant is a protein: marketed, first approved in 2002 (EU); acts on GHR; US protection ended in 2015.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2005
Kind
Protein
Brand name
Somavert
First approved
12 November 2002 (EU)
Approvals on record
17 in 4 regions
Holder of the most recent approval
Pfizer; 3 holders in all
Registered trials
26, 1 stopped early
Disease areas
Hormones; Bones, joints and muscles; Nervous system; Nutrition and metabolism; Cancer; Digestive system

US protection

US protection ended in 2015.

US protection ended in 2015, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Pfizer. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Target

GeneProteinUniProt
GHRGrowth hormone receptorP10912

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated9800
Phase 11001
Phase 22110
Phase 35500
Phase 49700
All trials26

Who has held its approvals

CompanyRoleYears
PfizerApplicant and Lead sponsor of trials2002 to now