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Nplate (ROMIPLOSTIM)
Nplate works by binding to the thrombopoietin receptor to stimulate platelet production.
Nplate (Romiplostim) is a thrombopoietin receptor agonist developed by Amgen, targeting the thrombopoietin receptor to stimulate platelet production. It is a small molecule modality approved by the FDA in 2008 for the treatment of aplastic anemia and chronic idiopathic thrombocytopenic purpura. Nplate is a patented medication, and its commercial status is maintained by Amgen. Key safety considerations include the risk of hypersensitivity reactions and the potential for increased platelet counts. In plain terms, Nplate works by binding to the thrombopoietin receptor, mimicking the natural hormone thrombopoietin to stimulate platelet production in the bone marrow.
At a glance
| Generic name | ROMIPLOSTIM |
|---|---|
| Sponsor | Amgen |
| Drug class | Thrombopoietin Receptor Agonist [EPC] |
| Target | Thrombopoietin receptor |
| Modality | Recombinant protein |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2008 |
| Annual revenue | 1524 |
Mechanism of action
Nplate increases platelet production through binding and activation of the TPO receptor, mechanism analogous to endogenous TPO.
Approved indications
- Aplastic anemia
- Chronic idiopathic thrombocytopenic purpura
Common side effects
- Headache
- Dizziness
- Arthralgia
- Myalgia
- Pain in Extremity
- Abdominal pain
- Insomnia
- Shoulder Pain
- Paresthesia
- Dyspepsia
- Upper respiratory tract infection
- Oropharyngeal pain
Key clinical trials
- Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) (PHASE3)
- Single Arm Romiplostim to Prevent CIT (EARLY_PHASE1)
- High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly (PHASE2)
- A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP) (PHASE2)
- Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer (PHASE3)
- Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy (PHASE2)
- Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA (PHASE2)
- Romiplostim N01 for Platelet Recovery After Haploidentical HSCT (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nplate CI brief — competitive landscape report
- Nplate updates RSS · CI watch RSS
- Amgen portfolio CI