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P1101
P1101 is a recombinant human thrombopoietin (TPO) analog that stimulates platelet production by binding to the thrombopoietin receptor.
P1101 is a recombinant human thrombopoietin (TPO) analog that stimulates platelet production by binding to the thrombopoietin receptor. Used for Immune thrombocytopenia (ITP), Chemotherapy-induced thrombocytopenia.
At a glance
| Generic name | P1101 |
|---|---|
| Also known as | Ropeginterferon alfa-2b, ropeginterferon alfa-2b, PEG-Proline-Interferon alpha-2b |
| Sponsor | PharmaEssentia Japan K.K. |
| Drug class | Thrombopoietin receptor agonist |
| Target | TPO receptor (c-Mpl) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
P1101 mimics the action of endogenous thrombopoietin, a cytokine that regulates megakaryopoiesis and platelet production. By activating TPO receptors on hematopoietic stem cells and megakaryocyte progenitors, it increases platelet counts in patients with thrombocytopenia. This mechanism is particularly useful in treating immune thrombocytopenia and chemotherapy-induced thrombocytopenia.
Approved indications
- Immune thrombocytopenia (ITP)
- Chemotherapy-induced thrombocytopenia
Common side effects
- Headache
- Fatigue
- Thrombotic events
- Bone pain
Key clinical trials
- Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia (PHASE2)
- Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL) (PHASE1)
- Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (PHASE2)
- P1101 in Treating Patients With Myelofibrosis (PHASE2)
- Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply (PHASE2)
- Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance (PHASE3)
- A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV (PHASE3)
- P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk (PHASE3)
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:
- P1101 CI brief — competitive landscape report
- P1101 updates RSS · CI watch RSS
- PharmaEssentia Japan K.K. portfolio CI