Wednesday, July 8, 2026

Drug profile · INN

peginesatide acetate

peginesatide acetate (OMONTYS) is a erythropoietin receptor agonist. Associated with Takeda. Route of administration: intravenous, subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — peginesatide acetate
US status
approved
Class
Route
INTRAVENOUS, SUBCUTANEOUS
Patents
0
Programs
2
Data quality
0.89

Quick answer

peginesatide acetate (OMONTYS) is a erythropoietin receptor agonist. Associated with Takeda. Route of administration: intravenous, subcutaneous. Current US regulatory status: approved.

Key facts

INN peginesatide acetate
Brand OMONTYS
Mechanism Erythropoietin receptor agonist
Target Erythropoietin receptor
Route INTRAVENOUS, SUBCUTANEOUS
Formulation SOLUTION
Originator Takeda

Mechanism of action

Erythropoietin receptor agonist

Primary target: Erythropoietin receptor

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. peginesatide Phase 3 · Takeda · Chronic Renal Failure
  2. peginesatide Phase 2 · Takeda · Anemia

Related & competitor drugs

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  3. darbepoetin alfa Blood and blood forming organs (B03)
  4. epoetin alfa Blood and blood forming organs (B03)
  5. epoetin alfa-epbx Erythropoietin receptor agonist
  6. methoxy polyethylene glycol-epoetin beta Blood and blood forming organs (B03)

Frequently asked questions

What is peginesatide acetate?

peginesatide acetate (OMONTYS) is a erythropoietin receptor agonist. Associated with Takeda. Route of administration: intravenous, subcutaneous. Current US regulatory status: approved.

What is the brand name for peginesatide acetate?

OMONTYS is a marketed brand name for peginesatide acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of peginesatide acetate?

peginesatide acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.