Drugs / Avatrombopag
Avatrombopag
also known as
E5501 · AVA · Akr-501 · Avatrombopag maleate · Doptelet · E-5501 MALEATE · YM-301477 · YM-477
Small molecule targets MPL via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DOPTELET | — | 2019-06-26 – 2025-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Doptelet | — | 2019-06-20 | europa.eu ↗ |
| Approved | US (FDA) | DOPTELET | — | 2018-05-21 | fda.gov ↗ |
Trials 53 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04931849 | May 2022 → Oct 2023 | thrombocytopenia | University of Rochester | Withdrawn | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT02809768 | Apr → Aug 2016 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02039076 | Dec 2013 → Jun 2014 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01774773 | Jan → Jul 2013 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01759394 | Oct 2012 → Jan 2013 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01549054 | Jan → Jun 2012 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01437384 | Sep 2011 → Mar 2012 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01327872 | Feb → Apr 2011 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01289509 | Dec 2010 → Mar 2011 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01251731 | Jul 2010 → Jan 2011 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01260155 | Jan → Jun 2010 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 218 trials | ||||||
| Phase 2 | NCT06281327 | Mar 2024 → Dec 2025 overdue | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06254287 | Feb → Dec 2024 | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 2 | NCT05772546 | Nov 2023 → Jan 2026 overdue | digestive system cancer, thrombocytopenia | Hanny Al-Samkari, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06004752 | Aug 2023 → Aug 2024 | aplastic anemia | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06001567 | Aug 2023 → Aug 2024 | hepatocellular carcinoma, thrombocytopenia | Second Affiliated Hospital of Guangzhou Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT04312789 | Dec 2022 | platelet disorder, undefined | Ayman Saad | Withdrawn | No outcome recorded |
| Phase 2 | NCT05720234 | Nov 2022 → Nov 2023 | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 2 | NCT05218226 | Feb 2022 → Dec 2024 | thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 2 | NCT05143892 | Dec 2021 → Dec 2022 | platelet disorder, undefined | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 2 | NCT04993885 | Sep 2021 → Jul 2024 overdue | Evans syndrome, connective tissue disorder | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT04896528 | Jun → Dec 2021 | thrombocytopenia | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04797182 | Apr 2021 → Apr 2023 | chemotherapy-induced toxicity, lymphoma, thrombocytopenia | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04437953 | May → Dec 2020 | cancer, liver disorder, thrombocytopenia | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT02227693 | Jul 2014 → Apr 2015 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01355289 | Nov 2011 → Feb 2014 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00914927 | May 2009 → Nov 2011 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00625443 | May 2007 → Jun 2009 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00441090 | Feb 2007 → Jan 2009 | autoimmune thrombocytopenic purpura | Eisai Inc. | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT07278908 | Dec 2025 → Dec 2028 expected | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06202625 | May → Oct 2024 overdue | disease related to hematopoietic stem cell transplant, thrombocytopenia | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT04915482 | Jun 2021 → Jan 2025 | Evans syndrome, connective tissue disorder | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 2/3 | NCT04728789 | Feb 2021 → Dec 2022 | aplastic anemia | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT07051915 | Sep 2025 → Jan 2028 expected | thrombocytopenic purpura | Ostfold Hospital Trust | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05369208 | Jun 2022 → Jan 2024 | autoimmune thrombocytopenia | Sobi, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05046327 | Oct 2021 → Apr 2024 | autoimmune thrombocytopenia | Sobi, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT04516967 | Mar 2021 → Nov 2023 | autoimmune thrombocytopenia | Sobi, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03471078 | Oct 2018 → Aug 2020 | thrombocytopenia | Sobi, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03326843 | Mar 2018 → Feb 2019 | thrombocytopenia | Sobi, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01972529 | Feb 2014 → Jan 2017 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01976104 | Nov 2013 → Jan 2017 | thrombocytopenia | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01433978 | Mar 2012 → Sep 2013 | autoimmune thrombocytopenic purpura | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01438840 | Feb 2012 → Nov 2013 | thrombocytopenia due to immune destruction | Eisai Inc. | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07133659 | Jun 2025 → Jul 2026 overdue | autoimmune thrombocytopenia | Al-Mustansiriyah University | Recruiting | No outcome recorded |
| Phase 4 | NCT05382013 | Apr 2022 → Feb 2024 | chronic hepatitis B virus infection, thrombocytopenia | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 4 | NCT04915287 | Jun 2021 → Jun 2023 | liver disorder, thrombocytopenia | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04845659 | Jun 2021 → Jun 2022 | cirrhosis of liver, thrombocytopenia | Hvidovre University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04638829 | Mar 2021 → Jan 2024 | autoimmune thrombocytopenia | Sobi, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04906083 | Feb 2021 → Dec 2022 | cirrhosis of liver, liver failure, thrombocytopenia | Tongji Hospital | Unknown | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT05571332 | Jun 2022 → Dec 2023 | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| — | NCT05518331 | Jun 2022 → Jun 2025 | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| — | NCT05433922 | Jun 2022 → Dec 2023 | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| — | NCT04609891 | May 2020 → May 2021 | thrombocytopenia | Anhui Provincial Cancer Hospital | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07421167 Background | Jun 2026 → Apr 2028 expected | Evans syndrome | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05907499 Background | Jul 2023 → Jul 2026 overdue | — | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05996393 Background | Sep 2023 → Feb 2025 | aplastic anemia | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05718856 Comparator | Feb 2023 → May 2025 | primary thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Avatrombopag | “Eltrombopag initial dose: 25 mg orally once a day, may increase to up to 75 mg/day, when platelet count ≤ 30 × 109/L; Avatrombopag initial dose: 20 mg orally once a day, may...” NCT05907499 ↗48“Three TPO-RAs could be used in this study, including eltrombopag, hetrombopag and avatrombopag.” NCT05718856 ↗ “The starting dose of avatrombopag is 20-40mg once daily.” NCT04915482 ↗ “avatrombopag” NCT07421167 ↗ |
| Known as | Akr-501 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103883 ↗ |
| Known as | AVA | “Avatrombopag (AVA) is prescribed for thrombocytopenic diseases but not for NSAA.” PMID 37318085 ↗ Dec 20231“addition of avatrombopag (AVA), which has a slight adverse reaction” NCT06004752 ↗ |
| Known as | Avatrombopag maleate | “Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base)” NCT01759394 ↗ |
| Known as | Doptelet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04845659 ↗ |
| Known as | E-5501 MALEATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103883 ↗ |
| Known as | E5501 | “E5501 (avatrombopag) 20-mg tablets” NCT02227693 ↗ |
| Known as | YM-301477 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103883 ↗ |
| Known as | YM-477 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103883 ↗ |
| Action | Activate | “avatrombopag, an investigational thrombopoietin-receptor agonist” PMID 24802775 ↗ May 20141“Thrombopoietin receptor agonist” CHEMBL2103883 ↗ |
| Modality | Small molecule | “once-daily oral avatrombopag (2.5, 5, 10, or 20 mg), an investigational nonpeptide TPO-RA active in humans” PMID 24802775 ↗ May 2014 |
| Route | Oral | “once-daily oral avatrombopag” PMID 24802775 ↗ May 2014 |
| Target | MPL | “Thrombopoietin receptor agonist” CHEMBL2103883 ↗ |