Omontys

(Peginesatide)

ApprovedPeptide

Omontys is a peptide that works as a Erythropoietin Receptor Agonist; Erythropoietin Receptor Agonist.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

Omontys is one of 108 small molecule programs targeting Anemia (phenotype). It is currently in Approved.

Indications

Total Trials

Active Trials

107

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Anemia (phenotype)Active, not recruiting

AnemiaActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Anemia (phenotype)Approved

Active, not recruiting

AnemiaPhase 3

Active, not recruiting

Chronic Kidney DiseasePhase 2

Active, not recruiting

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Omontys

Takeda

Approved

6 2

Aranesp

Amgen

Preclinical

40 3

Uloric

Takeda

Preclinical

3 4

Sovaldi

Gilead

Preclinical

1 5

Glucotrol

Pfizer

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Miochol

BBausch Health Americas, Inc.

Preclinical

2 10

Epoetin Beta

Roche

Preclinical

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

Clinical

Trials by Indication[1]

Anemia9 trials

Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD (EU)

Terminated·AAffymax·Phase 2·NCT00453973·114 enrolled

Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis

Completed·AAffymax·Phase 2·NCT00434330·91 enrolled

Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.

Completed· Takeda logo

Takeda·Phase 2·NCT00752791·59 enrolled

Show 6 more trials

Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

Completed·AAffymax·Phase 2·NCT00680043·114 enrolled

Peginesatide for Anemia in Chronic Hemodialysis Patients

Completed·AAffymax·Phase 2·NCT00228449·165 enrolled

Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD

Terminated·AAffymax·Phase 2·NCT00372489·81 enrolled

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

Completed·AAffymax·Phase 3·NCT00598442·493 enrolled

Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.

Completed· Takeda logo

Takeda·Phase 2·NCT00752609·102 enrolled

Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

Completed·AAffymax·Phase 3·NCT00598273·490 enrolled

Chronic Kidney Disease6 trials

Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease

Completed· Takeda logo

Takeda·Phase 2·NCT00314795·22 enrolled

Safety, PD & PK of Multiple Doses of Peginesatide for Anemia in Chronic Kidney Disease Patients

Completed·AAffymax·Phase 2·NCT00228436·139 enrolled

Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis

Completed· Takeda logo

Takeda·Phase 3·NCT01478971·184 enrolled

Show 3 more trials

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

Completed·AAffymax·Phase 3·NCT00597753·803 enrolled

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

Completed·AAffymax·Phase 3·NCT00597584·823 enrolled

Safety of Single Doses of Peginesatide in Patients With Chronic Kidney Disease

Terminated·AAffymax·Phase 2·NCT00109291·17 enrolled

Chemotherapy2 trials

A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

Terminated· Takeda logo

Takeda·Phase 1·NCT00629876·2 enrolled

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Completed·AAffymax·Phase 2·NCT00272662·60 enrolled

Intravenous1 trial

Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

Completed·AAffymax·Phase 1·NCT00097747·28 enrolled

Hemodialysis1 trial

Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis

Terminated· Amgen logo

Amgen·Phase 4·NCT01737879·41 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 27, 2012

OMONTYS

NDA NDA202799

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Peginesatide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Peginesatide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Peginesatide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202799). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Omontys. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Erythropoietin Receptor Agonist; Erythropoietin Receptor Agonist[2]
Modality: Peptide[2]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[5]

Patent #Expires

7550433Jun 2, 2026

7919461Jun 2, 2026

Omontys

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Anemia9 trials

Chronic Kidney Disease6 trials

Chemotherapy2 trials

Intravenous1 trial

Hemodialysis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News