Drugs / Hetrombopag
Hetrombopag
also known as
Hetrombopag Olamine · Hetrombopag (HPAG) · Hetrombopag Olamine Tablets · HPAG · SHR8735 · SHR8735 Olamine
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT04701216 | Feb → Jul 2021 | — | Atridia Pty Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05088642 | Sep → Dec 2020 | aplastic anemia | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04688008 | Sep → Oct 2020 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05088343 | Sep 2020 → Jan 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05088174 | Sep → Oct 2020 | aplastic anemia | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03977805 | May → Jun 2019 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02614846 | Aug 2015 → Mar 2016 | autoimmune thrombocytopenic purpura | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02403440 | Apr 2014 → Apr 2015 | autoimmune thrombocytopenic purpura | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02409394 | Mar → Apr 2014 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01830660 | Apr 2012 → Jun 2013 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT03557099 | Jun 2018 → Oct 2019 | aplastic anemia | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 216 trials | ||||||
| Phase 2 | NCT07523009 | Jun 2026 → Dec 2028 | aplastic anemia | Peking Union Medical College Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT07647029 | May 2026 → Feb 2028 expected | chemotherapy-induced toxicity | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07408648 | Apr 2026 → Apr 2027 expected | thrombocytopenia | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07558434 | Apr 2026 → Dec 2028 expected | aplastic anemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07252375 | Nov 2025 → May 2028 expected | nasopharyngeal carcinoma, thrombocytopenia | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07101627 | Aug 2025 → Apr 2027 expected | lung cancer | Shanghai Pulmonary Hospital, Shanghai, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07010237 | Feb 2025 → Dec 2028 expected | aplastic anemia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07492693 | Oct 2024 → Jul 2026 overdue | chemotherapy-induced toxicity | Changhai Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06099925 | Oct 2023 → Sep 2025 | thrombocytopenia | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT06036966 | Sep 2023 → Jul 2025 | thrombocytopenia | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05943691 | Sep 2023 → Jul 2024 | autoimmune thrombocytopenia | Shandong University | Unknown | No outcome recorded |
| Phase 2 | NCT05969158 | Sep 2023 → May 2025 | thrombocytopenia | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05394285 | Sep 2022 → Jun 2025 | breast cancer | Henan Cancer Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05442632 | Jul 2022 → Dec 2025 | liver disorder | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT05392647 | Jul 2022 → Jul 2024 | myelodysplastic syndrome | Tongji Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06433830 | May 2022 → May 2025 | thrombocytopenia | Sir Run Run Shaw Hospital | Unknown | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05018936 | Oct 2021 → Oct 2023 | aplastic anemia | Peking Union Medical College Hospital | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT05024877 | Oct 2021 → Oct 2023 | myelodysplastic syndrome | Peking Union Medical College Hospital | Unknown | 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 37 trials · 4 met primary | ||||||
| Phase 3 | NCT05864014 | Apr 2023 → Mar 2025 overdue | thrombocytopenia | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | Met primary |
| Phase 3 | NCT05261646 | Apr 2022 → Mar 2025 | thrombocytopenia | Jiangsu HengRui Medicine Co., Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04737850 | Mar 2021 → Dec 2024 | autoimmune thrombocytopenia | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03976882 | Nov 2019 → Feb 2023 | thrombocytopenia | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT04961710 | Sep 2019 → Nov 2024 overdue | idiopathic aplastic anemia | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03825744 | Mar 2019 → Jul 2024 | aplastic anemia | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03222843 | Jun 2017 → Nov 2019 | autoimmune thrombocytopenic purpura | Jiangsu HengRui Medicine Co., Ltd. | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06562738 | Jun 2024 → Jan 2025 overdue | thrombocytopenia | The Third People's Hospital of Chengdu | Recruiting | No outcome recorded |
| Phase 4 | NCT05311930 | May 2022 → Dec 2024 | autoimmune thrombocytopenia | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06818916 | Jun 2024 → Apr 2027 expected | neuroblastoma | Beijing Children's Hospital | Recruiting | No outcome recorded |
| — | NCT05727917 | Jan 2023 → May 2024 | disease related to hematopoietic stem cell transplant, hematologic disorder | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT07669675 Background | Jul 2026 → Dec 2027 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07334093 Comparator | Jan 2026 → Nov 2027 expected | acquired thrombocytopenia | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05718856 Comparator | Feb 2023 → May 2025 | primary thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory 恒瑞创新药恒曲®新适应症获批，6岁及以上儿童原发免疫性血小板减少症领域迎来首个中国自主研发的口服TPO-RA hengrui.com ↗
近日，恒瑞医药收到国家药品监督管理局的通知，批准公司自主研发的1类创新药恒曲 ® （海曲泊帕乙醇胺片）新增适应症：用于既往对糖皮质激素、免疫球蛋白等治疗反应不佳的慢性原发免疫性血小板减少症（ITP）≥6岁的儿童患者，使血小板计数升高并减少或防止出血。 |
| 2026-09-11 | Jiangsu HengRui Medicine Co., Ltd. | Regulatory CTIT领域全球首个获批的TPO-RA！恒瑞创新药恒曲®新适应症获批，口服给药助力CTIT全程管理 hengrui.com ↗
近日，恒瑞医药收到国家药品监督管理局的通知，批准公司自主研发的1类创新药恒曲 ® （海曲泊帕乙醇胺片）新增适应症： 用于实体瘤化疗为主的抗肿瘤治疗所致血小板减少症（CTIT）成人患者 。 |
| 2026-06-15 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 EHA｜恒瑞创新药海曲泊帕、立康可泮、泽美妥司他等10余项血液学最新研究成果亮相 hengrui.com ↗
第14天血小板计数>75×10⁹/L的患者比例为76%（19/25）；第21天血小板计数>75×10⁹/L和≥100×10⁹/L的患者比例分别为83%（20/24）和79%（19/24）。 |
| 2026-05-06 | Jiangsu HengRui Medicine Co., Ltd. | Results 恒瑞创新药海曲泊帕治疗儿童和青少年原发免疫性血小板减少症III期研究数据荣登JHO hengrui.com ↗
第10周时，海曲泊帕组61.4%（35/57）的患儿达到血小板计数≥50×10⁹/L，而安慰剂组仅为9.7%（3/31），组间率差为52.7%（95% CI：35.9-69.5，P<0.0001），证实了海曲泊帕可显著提升儿童和青少年ITP患者的血小板应答率。 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-11 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药恒曲®新适应症获批，6岁及以上儿童原发免疫性血小板减少症领域迎来首个中国自主研发的口服TPO-RA hengrui.com ↗ |
| 2026-09-11 | Jiangsu HengRui Medicine Co., Ltd. | CTIT领域全球首个获批的TPO-RA！恒瑞创新药恒曲®新适应症获批，口服给药助力CTIT全程管理 hengrui.com ↗ |
| 2026-06-15 | Jiangsu HengRui Medicine Co., Ltd. | 2026 EHA｜恒瑞创新药海曲泊帕、立康可泮、泽美妥司他等10余项血液学最新研究成果亮相 hengrui.com ↗ |
| 2026-05-06 | Jiangsu HengRui Medicine Co., Ltd. | 恒瑞创新药海曲泊帕治疗儿童和青少年原发免疫性血小板减少症III期研究数据荣登JHO hengrui.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Hetrombopag | “Oral Hetrombopag Olamine Tablets will be initiated at a daily dose of 5 mg (initial dose) on Day 1 (D1) of each chemotherapy cycle, and administered continuously until the...” NCT07252375 ↗42“Hetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days” NCT07669675 ↗ “Three TPO-RAs could be used in this study, including eltrombopag, hetrombopag and avatrombopag.” NCT05718856 ↗ “The starting dose of hetrombopag is 5.0-7.5mg once daily.” NCT04915482 ↗ “Hetrombopag 7.5mg/d, increased by 2.5mg every two weeks” NCT07558434 ↗ “hetrombopag 7.5mg/d, maximum dose 15mg/d” NCT07523009 ↗ |
| Known as | Hetrombopag (HPAG) | “Hetrombopag (HPAG)” NCT07558434 ↗ |
| Known as | Hetrombopag Olamine | “A Phase I, Randomized, Placebo-controlled, Ascending Single And Multiple Oral Dose Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of...” NCT01830660 ↗3“Drug: Hetrombopag Olamine” NCT03557099 ↗ “Drug: Hetrombopag Olamine” NCT02614846 ↗ “Drug: Hetrombopag Olamine” NCT03222843 ↗ |
| Known as | Hetrombopag Olamine Tablets | “Oral Hetrombopag Olamine Tablets will be initiated at a daily dose of 5 mg (initial dose) on Day 1 (D1) of each chemotherapy cycle, and administered continuously until the...” NCT07252375 ↗ |
| Known as | HPAG | “eltrombopag (EPAG)/hetrombopag (HPAG)” NCT07523009 ↗ |
| Known as | SHR8735 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04701216 ↗ |
| Known as | SHR8735 Olamine | “A Phase I, Randomized, Placebo-controlled, Ascending Single And Multiple Oral Dose Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of...” NCT01830660 ↗ |
| Action | Activate | “Hetrombopag is a novel, small-molecule thrombopoietin receptor agonist” PMID 32865293 ↗ Oct 2020 |
| Modality | Small molecule | “Hetrombopag is a novel, small-molecule thrombopoietin receptor agonist” PMID 32865293 ↗ Oct 2020 |
| Route | Oral | “hetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily” NCT01830660 ↗ |