Drugs / Lusutrombopag
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Mulpleo (previously Lusutrombopag Shionogi) | — | 2026-04-14 | europa.eu ↗ |
| Approved | EU (EMA) | Mulpleo (previously Lusutrombopag Shionogi) | — | 2019-02-18 | europa.eu ↗ |
| Approved | US (FDA) | MULPLETA | — | 2018-07-31 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03897413 | Nov → Dec 2009 | — | Shionogi | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06673498 | Nov 2024 → Nov 2025 overdue | thrombocytopenia | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06287567 | Apr → Nov 2024 | autoimmune thrombocytopenic purpura | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 2 | NCT01129024 | Apr 2010 → Jun 2011 | autoimmune thrombocytopenia | Shionogi | Terminated | No outcome recorded |
| Phase 2 | NCT01054443 | Mar → Nov 2010 | autoimmune thrombocytopenia | Shionogi | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02389621 | Jun 2015 → Apr 2017 | liver disorder, thrombocytopenia | Shionogi | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06426043 | Jun 2024 → Jun 2025 | aplastic anemia | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07483385 | Jan 2026 → Jan 2027 expected | disease related to hematopoietic stem cell transplant, hematologic disorder | The General Hospital of Western Theater Command | Recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lusutrombopag | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06426043 ↗ |
| Known as | Mulpleo (previously lusutrombopag shionogi) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107831 ↗ |
| Known as | Mulpleta | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107831 ↗ |
| Known as | RSC888711 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107831 ↗ |
| Known as | S-888711 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03897413 ↗ |
| Action | Activate | “Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.” PMID 32205226 ↗ Mar 20201“Thrombopoietin receptor agonist” CHEMBL2107831 ↗ |
| Modality | Small molecule | — CHEMBL2107831 ↗ |
| Route | Oral | “Participants received 0.5 mg lusutrombopag orally once a day for 42 days.” NCT01054443 ↗ |
| Target | MPL | “Thrombopoietin receptor agonist” CHEMBL2107831 ↗ |