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Eltrombopag PfOS
Eltrombopag PfOS is a Thrombopoietin receptor agonist Small molecule drug developed by Institute of Hematology & Blood Diseases Hospital, China. It is currently in Phase 3 development for Immune thrombocytopenia (ITP), Thrombocytopenia associated with chronic hepatitis C.
Eltrombopag is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on megakaryocytes.
Eltrombopag is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on megakaryocytes. Used for Immune thrombocytopenia (ITP), Thrombocytopenia associated with chronic hepatitis C.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Eltrombopag PfOS |
|---|---|
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Drug class | Thrombopoietin receptor agonist |
| Target | TPO receptor (TPOR/MPL) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
Eltrombopag mimics the action of thrombopoietin, a natural hormone that regulates platelet production. By activating TPO receptors on bone marrow megakaryocytes, it promotes their proliferation and differentiation, leading to increased platelet output. This mechanism is used to treat conditions characterized by low platelet counts (thrombocytopenia).
Approved indications
- Immune thrombocytopenia (ITP)
- Thrombocytopenia associated with chronic hepatitis C
Common side effects
- Headache
- Diarrhea
- Nausea
- Thrombotic events
- Hepatotoxicity
Key clinical trials
- rhTPO Dose Escalation vs Eltrombopag Switch in ITP (NA)
- Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP (PHASE4)
- Study on the Short-term Efficacy and Safety of Recombinant Human Thrombopoietin Combined With Immunosuppressant Sequential Eltrombopag Ethanolamine Dry Suspension in the Treatment of SAA/TD-NSAA (PHASE3)
- A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia (PHASE2)
- A Rollover Study to Provide Continued Treatment With Eltrombopag (PHASE4)
- A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP) (PHASE3)
- Thrombocytopenia and Bleeding in Wiskott-Aldrich Syndrome (WAS) Patients (PHASE2)
- Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect (PHASE1)
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:
- Eltrombopag PfOS CI brief — competitive landscape report
- Eltrombopag PfOS updates RSS · CI watch RSS
- Institute of Hematology & Blood Diseases Hospital, China portfolio CI
Frequently asked questions about Eltrombopag PfOS
What is Eltrombopag PfOS?
How does Eltrombopag PfOS work?
What is Eltrombopag PfOS used for?
Who makes Eltrombopag PfOS?
What drug class is Eltrombopag PfOS in?
What development phase is Eltrombopag PfOS in?
What are the side effects of Eltrombopag PfOS?
What does Eltrombopag PfOS target?
Related
- Drug class: All Thrombopoietin receptor agonist drugs
- Target: All drugs targeting TPO receptor (TPOR/MPL)
- Manufacturer: Institute of Hematology & Blood Diseases Hospital, China — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Immune thrombocytopenia (ITP)
- Indication: Drugs for Thrombocytopenia associated with chronic hepatitis C
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing