NPLATE

(Nplate)

Phase 3Small molecule

Amgen

NPLATE is one of 41 small molecule programs targeting Immune Thrombocytopenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Immune ThrombocytopeniaActive, not recruiting

Immune ThrombocytopeniaPhase 3

Active, not recruiting

Competition

Competitive Landscape

135 competitors in Immune Thrombocytopenia

#DrugCompanyPhaseTrials

Nplate

Amgen

Phase 3

8 2

Rysodeg

UCB

Phase 3

3 3

Cellcept

Roche

Phase 3

2 4

Doptelet

AAkarx

Phase 3

6 5

Vyvgart

Argenx

Phase 3

6 6

Fabhalta

Johnson & Johnson

Phase 3

—7

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

3 8

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

3 9

Avlosulfon

AAlmirall, S.A.

Phase 3

1 10

Tamiflu

CConrado Roberto Hoffmann Filho

Phase 3

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

Timeline

Expected Milestones

Q1 2028

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT06497036

Q2 2028

Phase 2Not yet recruiting

Cardiac Surgery

NCT07278661

Clinical

Trials by Indication[1]

Cardiac Surgery1 trial

Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.

Not yet recruiting·NNantes University Hospital·Phase 2·NCT07278661·136 enrolled

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

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

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

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 3[1]
Company: Amgen

NPLATE

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Q2 2028

Trials by Indication[1]

Cardiac Surgery1 trial

Immune Thrombocytopenia1 trial

Double-blind1 trial

Clinical Efficacy and Safety1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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