Overview
Avatrombopag (Doptelet), is an orally administered, small-molecule thrombopoietin receptor (c-Mpl) agonist which increases platelet number, but not platelet activation , . This decreases the need for blood transfusions . Patients with thrombocytopenia and chronic liver disease (leading to thrombocytopenia) often require platelet transfusions before surgical procedures to decrease the risk of bleeding . Thrombocytopenia (or decreased numbers of platelets) is a common complication in patients suffering from chronic liver disease, either as an immediate result of liver disease or a consequence of interferon-based antiviral therapy . Avatrombopag was approved by the FDA on May 21, 2018 for thrombocytopenia (low platelets) in adults with chronic liver disease who are scheduled to undergo a procedure . It is administered orally as avatrombopag maleate, its salt form . Doptelet (Avatrombopag) is the first orally administered treatment option for patients with chronic liver disease, allowing a large population of patients to avoid a platelet transfusion before a procedure by increasing platelet counts to the optimal level of greater or equal to 50,000 per microliter .
Background
Avatrombopag (Doptelet), is an orally administered, small-molecule thrombopoietin receptor (c-Mpl) agonist which increases platelet number, but not platelet activation , . This decreases the need for blood transfusions . Patients with thrombocytopenia and chronic liver disease (leading to thrombocytopenia) often require platelet transfusions before surgical procedures to decrease the risk of bleeding . Thrombocytopenia (or decreased numbers of platelets) is a common complication in patients suffering from chronic liver disease, either as an immediate result of liver disease or a consequence of interferon-based antiviral therapy . Avatrombopag was approved by the FDA on May 21, 2018 for thrombocytopenia (low platelets) in adults with chronic liver disease who are scheduled to undergo a procedure . It is administered orally as avatrombopag maleate, its salt form . Doptelet (Avatrombopag) is the first orally administered treatment option for patients with chronic liver disease, allowing a large population of patients to avoid a platelet transfusion before a procedure by increasing platelet counts to the optimal level of greater or equal to 50,000 per microliter .
Indication
Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure .
Associated Conditions
- Thrombocytopenia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/04 | Not Applicable | Not yet recruiting | Ostfold Hospital Trust | ||
2024/02/28 | Phase 2 | Recruiting | |||
2024/02/12 | Phase 2 | Not yet recruiting | |||
2024/01/11 | Phase 2 | Recruiting | |||
2023/08/22 | Phase 2 | Recruiting | |||
2023/08/21 | Phase 2 | Recruiting | Second Affiliated Hospital of Guangzhou Medical University | ||
2023/08/18 | Phase 4 | Completed | |||
2023/04/21 | N/A | Recruiting | Anhui Provincial Hospital | ||
2023/03/16 | Phase 2 | Recruiting | Hanny Al-Samkari, MD | ||
2023/02/09 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AkaRx, Inc. | 71369-020 | ORAL | 20 mg in 1 1 | 6/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/20/2019 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Avatrombopag Maleate tablet | 国药准字H20249300 | 化学药品 | 片剂 | 11/5/2024 | |
Avatrombopag Maleate tablet | 国药准字H20253106 | 化学药品 | 片剂 | 1/8/2025 | |
Avatrombopag Maleate tablet | 国药准字H20253117 | 化学药品 | 片剂 | 1/8/2025 | |
Avatrombopag Maleate tablet | 国药准字H20253526 | 化学药品 | 片剂 | 3/4/2025 | |
Avatrombopag Maleate tablet | 国药准字H20253548 | 化学药品 | 片剂 | 3/4/2025 | |
Avatrombopag Maleate tablet | 国药准字H20253325 | 化学药品 | 片剂 | 1/24/2025 | |
Avatrombopag Maleate tablet | 国药准字H20244130 | 化学药品 | 片剂 | 6/25/2024 | |
Avatrombopag Maleate tablet | 国药准字H20244142 | 化学药品 | 片剂 | 6/25/2024 | |
Avatrombopag Maleate tablet | 国药准字H20244403 | 化学药品 | 片剂 | 7/9/2024 | |
Avatrombopag Maleate tablet | 国药准字H20249585 | 化学药品 | 片剂 | 12/1/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
DOPTELET avatrombopag (as maleate) 20 mg film-coated tablets blister pack | 375471 | Medicine | A | 1/16/2023 |