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Avatrombopag tablets
Avatrombopag tablets is a Thrombopoietin receptor agonist Small molecule drug developed by Eisai Inc.. It is currently in Phase 2 development for Thrombocytopenia. Also known as: AKR-501, E5501, YM477.
Thrombopoietin receptor agonist
Avatrombopag tablets are a small molecule thrombopoietin receptor agonist, classified as an agonist. They are used to treat conditions such as chemotherapy-induced thrombocytopenia, immune thrombocytopenia, and idiopathic thrombocytopenia purpura.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Avatrombopag tablets |
|---|---|
| Also known as | AKR-501, E5501, YM477 |
| Sponsor | Eisai Inc. |
| Drug class | Thrombopoietin receptor agonist |
| Target | Thrombopoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Avatrombopag works by binding to and activating the thrombopoietin receptor, stimulating platelet production.
Approved indications
- Thrombocytopenia
Common side effects
- Nausea
- Headache
- Fatigue
Key clinical trials
- Avatrombopag vs. Placebo for CIT in GI Malignancies (PHASE2)
- Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months (PHASE3)
- Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP (PHASE3)
- The Holistic Study (PHASE3)
- Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study (PHASE4)
- Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim (PHASE4)
- Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers (PHASE3)
- Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure (PHASE4)
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:
- Avatrombopag tablets CI brief — competitive landscape report
- Avatrombopag tablets updates RSS · CI watch RSS
- Eisai Inc. portfolio CI
Frequently asked questions about Avatrombopag tablets
What is Avatrombopag tablets?
How does Avatrombopag tablets work?
What is Avatrombopag tablets used for?
Who makes Avatrombopag tablets?
Is Avatrombopag tablets also known as anything else?
What drug class is Avatrombopag tablets in?
What development phase is Avatrombopag tablets in?
What are the side effects of Avatrombopag tablets?
What does Avatrombopag tablets target?
Related
- Drug class: All Thrombopoietin receptor agonist drugs
- Target: All drugs targeting Thrombopoietin receptor
- Manufacturer: Eisai Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Thrombocytopenia
- Also known as: AKR-501, E5501, YM477
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing