Last reviewed · How we verify
Romiplostin
Romiplostin is a Small molecule drug developed by Gruppo Italiano Malattie EMatologiche dell'Adulto. It is currently in Phase 2 development. Also known as: Thrombopoietin Receptor Agonists (TPO-RAs).
Romiplostim is a thrombopoietin receptor agonist used to treat Immune Thrombocytopenia and Aplastic Anemia. It is compared to Eltrombopag in clinical trials to evaluate its effectiveness and response duration in these conditions.
-
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).
| 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 | Romiplostin |
|---|---|
| Also known as | Thrombopoietin Receptor Agonists (TPO-RAs) |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia
- Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study
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:
- Romiplostin CI brief — competitive landscape report
- Romiplostin updates RSS · CI watch RSS
- Gruppo Italiano Malattie EMatologiche dell'Adulto portfolio CI
Frequently asked questions about Romiplostin
What is Romiplostin?
Who makes Romiplostin?
Is Romiplostin also known as anything else?
What development phase is Romiplostin in?
Related
- Manufacturer: Gruppo Italiano Malattie EMatologiche dell'Adulto — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Thrombopoietin Receptor Agonists (TPO-RAs)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing