NPLATE (romiplostim)
NPLATE is indicated for the treatment of Thrombocytopenia; Immune Thrombocytopenia; Acute Radiation Syndrome.
How NPLATE Works
Nplate acts as a thrombopoietin (TPO) receptor agonist that increases the production of platelets. The drug achieves this therapeutic effect by binding to and activating the TPO receptor through a mechanism analogous to endogenous TPO. By stimulating this specific receptor, the medication promotes the biological processes responsible for platelet generation. This targeted activation helps address low platelet levels in patients with indicated conditions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2008-08-22
- Patent Cliff
- 2028
- Revenue
- $385M (Q4-2025)
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
NPLATE Approval History
What NPLATE Treats
3 indicationsNPLATE is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombocytopenia
- Immune Thrombocytopenia
- Acute Radiation Syndrome
NPLATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in NPLATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NPLATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to NPLATE
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07400341 PROMPT | SOOCHOW-WXJ-2025-1294 | Ph 2 | recruiting | Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA |
| NCT04673266 | 20-492 | Ph 2 | completed | Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma |
| NCT03937154 | 20170770 | Ph 3 | active not recruiting | Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer |
| NCT07278661 CT-PLATE | RC24_0458 2024-517710-15-00 | Ph 2 | recruiting | Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. |
| NCT06345495 | 2023-0899 NCI-2024-02814 | Ph 2 | recruiting | High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly |
| NCT03362177 RECITE results posted | 20140346 2017-002992-25 | Ph 3 | completed | Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer |
| NCT07001254 | 202308492 | Ph 2 | not yet recruiting | UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia |
| NCT04671901 results posted | 20-467 | Ph 2 | terminated | A Study of Romiplostim to Prevent Low Platelet Counts in Children and Young Adults Receiving Chemotherapy for Solid Tumors |
| NCT02052882 results posted | 13-132 | Ph 2 | completed | Study of Romiplostim for Chemotherapy Induced Thrombocytopenia |
| NCT06535685 | LRA-2024-002 | Ph 4 | not yet recruiting | A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA |
| NCT06516484 | LRA-2024-001 | Ph 4 | not yet recruiting | Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study |
| NCT02773290 | 531-002 | Ph 2, Ph 3 | completed | Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia |
| NCT06497036 | GP40141-P4-03-02 | Ph 3 | active not recruiting | Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia |
| NCT02868099 | 531-CN002 | Ph 3 | completed | Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) |
| NCT02868060 | 531-CN001 | Ph 1, Ph 2 | completed | Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP) |
| NCT05220878 | RMP-ITP-III № 407 eff. date 29 July 2021 | Ph 3 | completed | Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP |
| NCT04478123 results posted | 20-180 | Ph 2 | completed | Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer |
| NCT05323617 | 20210112 | Ph 2 | withdrawn | Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy |
| NCT04933942 RIGOLETTO | EORTC-1926-BTG | Ph 2 | withdrawn | Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma |
| NCT00614523 results posted | 20060198 | Ph 2 | completed | Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) |
| NCT00907478 results posted | 20080009 | Ph 4 | completed | Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP) |
| NCT01143038 results posted | 20080435 2010-019987-35 | Ph 2 | completed | Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim |
| NCT01516619 ProRom | ProRom | Ph 2 | completed | Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia |
| NCT02279173 results posted | 20101221 2011-005019-96 | Ph 3 | completed | Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP) |
| NCT03957694 | 531-003 | Ph 2, Ph 3 | completed | Study of AMG531(Romiplostim) in Patients With Aplastic Anemia |
| NCT04095936 | 531-004 | Ph 2, Ph 3 | completed | Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia |
| NCT02046291 | 2012LS089 MT2012-17R | Ph 1 | completed | Safety of Romiplostim (Nplate®) Following UCBT |
| NCT03622931 TRACEII | T-RACE II | Ph 2 | terminated | Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines |
| NCT02760251 iROM | 20149180 | Ph 4 | completed | Immunomodulation With Romiplostim in Young Adults With ITP |
| NCT01071954 results posted | 20090340 2009-016203-32 | Ph 3 | completed | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura |
| NCT00902018 results posted | 0809009980 | Ph 2 | completed | Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP) |
| NCT01980030 AGRAH003 | P110204 | Ph 1, Ph 2 | completed | Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell |
| NCT01676961 results posted | 10-02429 P30CA016087 | Ph 2 | terminated | Romiplostim in Increasing Low Platelet Counts in Patients With Multiple Myeloma Receiving Chemotherapy |
| NCT02227576 PLATUM | 2011_29 2012-001751-38 | Ph 2 | terminated | Prevention of Thrombocytopenia in Glioblastoma Patients |
| NCT03343847 | 20140347 2017-002995-16 | Ph 3 | withdrawn | Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma. |
| NCT01153919 | NC-HEM-07-5 NCI-2010-00358 | Ph 2 | terminated | Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia |
| NCT01444417 results posted | 20080279 2010-018426-39 | Ph 3 | completed | Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NPLATE FDA Label Details
Indications & Usage
FDA Label (PDF)NPLATE is indicated for the treatment of Thrombocytopenia; Immune Thrombocytopenia; Acute Radiation Syndrome.
Pro Intelligence Preview
Deep insights for NPLATE
Revenue Insights
- • Q4-2025: $385M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • Generic/biosimilar risk
Trial Analysis
- • 37 total trials
- • Stage: Stable
Competitive Landscape
- • 18 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment