Drug

Peginesatide

As of the edition of 20 October 2026, Peginesatide is a protein: withdrawn from the market in 2019; acts on EPOR; no US protection is listed.

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

The drug

Status
Withdrawn from market, 2019
Kind
Protein
Brand name
Omontys Preservative Free
First approved
27 March 2012 (US)
Approvals on record
8 in 1 region
Holder of the most recent approval
Takeda
Withdrawn from market
1 January 2019 (in some regions)
Registered trials
19, 5 stopped early
Disease areas
Blood and lymph; Pregnancy and women's health; Urinary and reproductive; Cancer

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route A because of this drug.

Companies on route A for this drug

In the product

1 company is on route A because of Peginesatide.

Target

GeneProteinUniProt
EPORErythropoietin receptorP19235

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 12101
Phase 211803
Phase 35500
Phase 41001
All trials19

Who has held its approvals

CompanyRoleYears
AffymaxOriginator and Lead sponsor of trials2004 to now
TakedaAcquired holder and Lead sponsor of trials2006 to now