Product Description
Lusutrombopag is used to treat thrombocytopenia (low platelets in the blood) in adults with chronic liver disease who are scheduled to have a medical or dental procedure. It works by stimulating the bone marrow to produce more platelets. (Sourced from: https://www.mayoclinic.org/drugs-supplements/lusutrombopag-oral-route/description/drg-20443925)
Mechanisms of Action: TPO Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Italy | Japan | Latvia | Lithuania | Netherlands | Poland | Portugal | Slovakia | Spain | Sweden | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Shionogi
Company Location: OSAKA M0 541-0045
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Anemia, Aplastic
Phase 3: Thrombocytopenia
Phase 2: Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ChiCTR2500102121 | N/A |
Not yet recruiting |
Thrombocytopenia |
2026-08-31 |
|||
| ChiCTR2400084012 | N/A |
Not yet recruiting |
Anemia, Aplastic |
2025-04-30 |
2024-05-09 |
Treatments |
|
| A pilot study to evaluate the efficacy and safety of lusutrombopag in ITP patients | N/A |
Not yet recruiting |
Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic |
2024-11-30 |
2024-01-29 |
Treatments |
|
| CTR20241144 | N/A |
Completed |
Thrombocytopenia |
2024-06-11 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| CTR20221711 | N/A |
Completed |
Thrombocytopenia |
2022-11-15 |
2025-04-29 |
||
| JapicCTI-163432 | N/A |
Unknown |
Thrombocytopenia |
2021-05-31 |
|||
| CTR20251459 | N/A |
Not yet recruiting |
Thrombocytopenia |
None |
2025-04-29 |
Treatments|Trial Status |
|
| CTR20250896 | N/A |
Not yet recruiting |
Thrombocytopenia |
None |
2025-04-29 |
Treatments|Trial Status |
|
| JapicCTI-194689 | P1 |
Completed |
Healthy Volunteers |
2013-04-30 |
|||
| 0924M0618 | P1 |
Completed |
Healthy Volunteers |
2009-12-23 |
2019-04-02 |
Treatments |
|
| JapicCTI-194690 | P1 |
Completed |
Healthy Volunteers |
2008-05-31 |
|||
| 2024KY402 | P2 |
Recruiting |
Thrombocytopenia |
2025-11-30 |
2024-11-06 |
||
| IIT2023078 | P2 |
Recruiting |
Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic |
2024-09-30 |
2024-07-23 |
Primary Endpoints|Treatments |
|
| 2009-017942-30 | P2 |
Active, not recruiting |
Purpura, Thrombocytopenic, Idiopathic|Thrombocytopenia |
2015-06-15 |
2022-03-13 |
Treatments |
|
| 0914M0622 | P2 |
Terminated |
Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic |
2011-06-30 |
2021-02-27 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
| 2009-016950-42 | P2 |
Completed |
Purpura, Thrombocytopenic, Idiopathic|Thrombocytopenia |
2011-01-25 |
2022-03-13 |
Treatments |
|
| 0913M0621 | P2 |
Terminated |
Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic |
2010-11-24 |
2021-02-25 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date |
|
| JapicCTI-111625 | P2 |
Completed |
Unknown |
None |
|||
| JapicCTI-101377 | P2 |
Completed |
Unknown |
None |
|||
| JapicCTI-163289 | P2 |
Completed |
Thrombocytopenia |
None |
|||
| L-PLUS 2 | P3 |
Completed |
Thrombocytopenia |
2017-04-19 |
2022-03-13 |
Treatments |
|
| L-PLUS 2 | P3 |
Completed |
Thrombocytopenia |
2017-04-05 |
2019-03-20 |
Treatments |
|
| JapicCTI-153023 | P3 |
Completed |
Thrombocytopenia |
None |
|||
| JapicCTI-132323 | P3 |
Completed |
Thrombocytopenia |
None |
|||
| LNA-2024 | P4 |
Not yet recruiting |
Anemia, Aplastic |
2025-06-01 |
2024-05-25 |
Primary Endpoints |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
10/14/2022 |
News Article |
Thrombocytopenia Market Insights, Epidemiology and Market Forecasts, 2032 |
|
06/08/2021 |
News Article |
Thrombocytopenia Market Insight, Epidemiology and Market Forecast Report 2021-2030 - ResearchAndMarkets.com |
|
12/09/2019 |
News Article |
Doptelet ® (avatrombopag) Demonstrates Cost-effectiveness for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease |
|
12/05/2019 |
News Article |
Data to be Highlighted at the American Society of Hematology 2019 Annual Meeting |