NPLATE

(Nplate)

Phase 2Small molecule

Amgen

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chirurgical InterventionRecruiting

Chirurgical InterventionPhase 2

Recruiting

Timeline

Expected Milestones

Q1 2028

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT06497036

Q4 2028

Phase 2Recruiting

Chirurgical Intervention

NCT07278661

Clinical

Trials by Indication[1]

Immune Thrombocytopenia1 trial

Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

Active, not recruiting·GGeropharm·Phase 3·NCT06497036·160 enrolled

Clinical Efficacy and Safety1 trial

Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Completed·AAO GENERIUM·Phase 3·NCT05220878·160 enrolled

Double-blind1 trial

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Unknown status·GGeropharm·Phase 1·NCT05652595·56 enrolled

Chirurgical Intervention1 trial

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.

Recruiting·NNantes University Hospital·Phase 2·NCT07278661·142 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 22, 2008

NPLATE

BLA BLA125268

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Nplate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nplate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nplate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125268). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Amgen

NPLATE

Status by Indication[3][1]

Expected Milestones

Q1 2028

Q4 2028

Trials by Indication[1]

Immune Thrombocytopenia1 trial

Clinical Efficacy and Safety1 trial

Double-blind1 trial

Chirurgical Intervention1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News