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Romiplostim N01
Romiplostim N01 is a Thrombopoietin receptor agonist Small molecule drug developed by Qilu Pharmaceutical Co., Ltd.. It is currently in Phase 3 development for Immune thrombocytopenia.
Romiplostim N01 is a thrombopoietin receptor agonist that stimulates platelet production.
Romiplostim N01 is a thrombopoietin receptor agonist that stimulates platelet production. Used for Immune thrombocytopenia.
At a glance
| Generic name | Romiplostim N01 |
|---|---|
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Drug class | Thrombopoietin receptor agonist |
| Target | Thrombopoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
It works by binding to the thrombopoietin receptor on megakaryocyte cells, leading to increased platelet production and count. This is particularly useful in treating conditions characterized by low platelet counts, such as immune thrombocytopenia.
Approved indications
- Immune thrombocytopenia
Common side effects
- Headache
- Nausea
- Fatigue
- Dizziness
- Cough
Key clinical trials
- 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 N01 for Platelet Recovery After Haploidentical HSCT (PHASE1)
- A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia (PHASE3)
- Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia (NA)
- A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors (NA)
- Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients (NA)
- Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors (PHASE2)
- Romiplostim N01 for Chemotherapy-induced Thrombocytopenia (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Romiplostim N01 CI brief — competitive landscape report
- Romiplostim N01 updates RSS · CI watch RSS
- Qilu Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Romiplostim N01
What is Romiplostim N01?
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What does Romiplostim N01 target?
Related
- Drug class: All Thrombopoietin receptor agonist drugs
- Target: All drugs targeting Thrombopoietin receptor
- Manufacturer: Qilu Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Immune thrombocytopenia
- Compare: Romiplostim N01 vs similar drugs
- Pricing: Romiplostim N01 cost, discount & access