{"id":"avatrombopag-oral-tablet","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Fatigue"}]},"_chembl":{"chemblId":"CHEMBL2103883","moleculeType":"Small molecule","molecularWeight":"649.67"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Avatrombopag mimics the action of endogenous thrombopoietin, a cytokine that regulates platelet production. By activating the TPO receptor (also called c-Mpl) on megakaryocyte progenitor cells, it promotes their proliferation and differentiation, leading to increased platelet output from the bone marrow. This mechanism is used to treat thrombocytopenia (low platelet counts) in patients with chronic liver disease undergoing invasive procedures or in patients with immune thrombocytopenia.","oneSentence":"Avatrombopag is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on bone marrow megakaryocytes.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:20:04.159Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Thrombocytopenia in patients with chronic liver disease undergoing invasive procedures"},{"name":"Chronic immune thrombocytopenia (ITP)"}]},"trialDetails":[{"nctId":"NCT05772546","phase":"PHASE2","title":"Avatrombopag vs. Placebo for CIT in GI Malignancies","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hanny Al-Samkari, MD","startDate":"2023-11-01","conditions":"Gastrointestinal Cancer, Gastrointestinal Neoplasms, Chemotherapy-Induced Thrombocytopenia","enrollment":60},{"nctId":"NCT04516967","phase":"PHASE3","title":"Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months","status":"COMPLETED","sponsor":"Sobi, Inc.","startDate":"2021-03-05","conditions":"Immune Thrombocytopenia","enrollment":75},{"nctId":"NCT05369208","phase":"PHASE3","title":"Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP","status":"COMPLETED","sponsor":"Sobi, Inc.","startDate":"2022-06-15","conditions":"Immune Thrombocytopenia","enrollment":19},{"nctId":"NCT07051915","phase":"PHASE3","title":"The Holistic Study","status":"NOT_YET_RECRUITING","sponsor":"Ostfold Hospital Trust","startDate":"2025-09-15","conditions":"Thrombocytopenia Purpura","enrollment":220},{"nctId":"NCT07133659","phase":"PHASE4","title":"Exploring the Efficacy, Safety of a Modified Starting Dosage of Avatrombopag in Immune Throbocytopenia (ITP) - a Pilot Study","status":"RECRUITING","sponsor":"Al-Mustansiriyah University","startDate":"2025-06-08","conditions":"ITP - Immune Thrombocytopenia","enrollment":25},{"nctId":"NCT04638829","phase":"PHASE4","title":"Safety and Treatment Satisfaction in Adults With Chronic ITP After Switching to Avatrombopag From Eltrombopag or Romiplostim","status":"COMPLETED","sponsor":"Sobi, Inc.","startDate":"2021-03-15","conditions":"Immune Thrombocytopenia","enrollment":60},{"nctId":"NCT03471078","phase":"PHASE3","title":"Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers","status":"COMPLETED","sponsor":"Sobi, Inc.","startDate":"2018-10-12","conditions":"Chemotherapy-induced Thrombocytopenia","enrollment":122},{"nctId":"NCT04915287","phase":"PHASE4","title":"Efficacy of Avatrombopag in Thrombocytopenic Patients With Chronic Liver Disease Undergoing an Elective Procedure","status":"UNKNOWN","sponsor":"Chinese PLA General Hospital","startDate":"2021-06-06","conditions":"Thrombocytopenia; Drugs, Chronic Liver Disease","enrollment":476},{"nctId":"NCT05571332","phase":"NA","title":"Efficacy and Safety of Avatrombopag Combined With IST for the Treatment of HAAA and SAA With Abnormal Liver Function","status":"UNKNOWN","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2022-06-28","conditions":"Aplastic Anemia","enrollment":39},{"nctId":"NCT04609891","phase":"NA","title":"Avatrombopag on the Treatment of Thrombocytopenia Induced by Chemotherapy of Malignant Tumors","status":"COMPLETED","sponsor":"Anhui Provincial Cancer Hospital","startDate":"2020-05-26","conditions":"Thrombocytopenia","enrollment":74},{"nctId":"NCT05046327","phase":"PHASE3","title":"Open-Label Study to Evaluate the Safety and Efficacy of Avatrombopag and Remission Rates in Adults With ITP of ≤6 Months","status":"WITHDRAWN","sponsor":"Sobi, Inc.","startDate":"2021-10-14","conditions":"Immune Thrombocytopenia","enrollment":""},{"nctId":"NCT02227693","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2014-07","conditions":"Thrombocytopenia Associated With Chronic Liver Disease","enrollment":39},{"nctId":"NCT00625443","phase":"PHASE2","title":"Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2007-05","conditions":"Idiopathic Thrombocytopenic Purpura","enrollment":53},{"nctId":"NCT00441090","phase":"PHASE2","title":"Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2007-02","conditions":"Chronic Idiopathic Thrombocytopenic Purpura, Purpura, Thrombocytopenic, Idiopathic","enrollment":64},{"nctId":"NCT01972529","phase":"PHASE3","title":"Treatment of Thrombocytopenia in Patients With Chronic Liver DiseaseUndergoing an Elective Procedure","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2014-02","conditions":"Thrombocytopenia Associated With Liver Disease","enrollment":231},{"nctId":"NCT01976104","phase":"PHASE3","title":"Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2013-11","conditions":"Thrombocytopenia Associated With Liver Disease","enrollment":204},{"nctId":"NCT00914927","phase":"PHASE2","title":"Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2009-05","conditions":"Thrombocytopenia Related to Chronic Liver Disease","enrollment":130},{"nctId":"NCT01260155","phase":"PHASE1","title":"A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2010-01","conditions":"Healthy Subjects","enrollment":16},{"nctId":"NCT01289509","phase":"PHASE1","title":"A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2010-12","conditions":"Idiopathic Thrombocytopenia Purpura","enrollment":42},{"nctId":"NCT01759394","phase":"PHASE1","title":"A Open-label, Three-period, Partial-replicate Design Study to Evaluate the Inter- and Intrasubject Variability of the Avatrombopag To-be-marketed Formulation Administered as Single Doses of 40 mg to Healthy Subjects Receiving a Low-fat Meal","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2012-10","conditions":"Healthy Volunteers","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Doptelet"],"phase":"marketed","status":"active","brandName":"Avatrombopag Oral Tablet","genericName":"Avatrombopag Oral Tablet","companyName":"Sobi, Inc.","companyId":"sobi-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Avatrombopag is a thrombopoietin (TPO) receptor agonist that stimulates platelet production by binding to and activating the TPO receptor on bone marrow megakaryocytes. Used for Thrombocytopenia in patients with chronic liver disease undergoing invasive procedures, Chronic immune thrombocytopenia (ITP).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}