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AMG 531
AMG 531 is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on megakaryocytes.
AMG 531 is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on megakaryocytes. Used for Chronic immune thrombocytopenia (ITP), Thrombocytopenia in patients with chronic hepatitis C.
At a glance
| Generic name | AMG 531 |
|---|---|
| Also known as | Romiplostim, romiplostim |
| Sponsor | Amgen |
| Drug class | Thrombopoietin receptor agonist |
| Target | TPO receptor (c-Mpl) |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
AMG 531 mimics the action of endogenous thrombopoietin, a cytokine that regulates megakaryocyte development and platelet production. By activating the TPO receptor (c-Mpl), the drug increases platelet counts in patients with thrombocytopenia. This mechanism allows for sustained elevation of platelet levels without the need for repeated transfusions.
Approved indications
- Chronic immune thrombocytopenia (ITP)
- Thrombocytopenia in patients with chronic hepatitis C
Common side effects
- Headache
- Fatigue
- Diarrhea
- Thrombotic events
- Bone marrow fibrosis
Key clinical trials
- 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)
- Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA (PHASE2)
- 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)
- Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer (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:
- AMG 531 CI brief — competitive landscape report
- AMG 531 updates RSS · CI watch RSS
- Amgen portfolio CI