eltrombopag
Trade name: promacta
Approved
Nov 20, 2008
Eltrombopag is a thrombopoietin (TPO) nonpeptide mimetic administered orally that activates the TPO receptor by binding to the transmembrane domain and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. Eltrombopag under brand name promacta is approved for the treatment of the low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the spleen, have not worked well enough. ITP is a condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood. Eltrombopag has also been approved for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy and to treat patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. — NCATS
Clinical trial activity
150 trials · 124 clinical orgs · 16 marketing orgs
Earliest trial started Feb 1, 2005 (NCT00102726)
Timeline
2000s
- Jan 1, 2005
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2006
- May 5, 2008
Orphan Drug Designation
- Nov 20, 2008
GlaxoSmithKline — Earliest FDA Approval
- Nov 20, 2008
GlaxoSmithKline — NDA Organization
- Nov 20, 2008
Novartis — NDA Secondary Org
- Nov 20, 2008
Novartis — Marketing Organization
2010s
- Jul 6, 2016
Hetero Labs Ltd — Marketing Organization
- Nov 28, 2017
Actavis — Marketing Organization
- Nov 28, 2017
Allergan PLC (2015) — Marketing Organization
- Feb 16, 2018
Teva — Marketing Organization
2020s
- Oct 3, 2022
Teva — NDA Secondary Org
- Apr 18, 2024
Annora Pharma — Marketing Organization
- Apr 30, 2024
Amneal Pharmaceuticals — Marketing Organization
- May 7, 2025
Dr. Reddy's Laboratories — Marketing Organization
- Aug 5, 2025
Somerset Therapeutics LLC — Marketing Organization
- Jan 14, 2026
MSN Laboratories — Marketing Organization
- Jan 14, 2026
Somerset Pharmaceuticals — Marketing Organization
- Jan 14, 2026
Zydus Discovery DMCC — Marketing Organization
- Apr 8, 2026
ZENARA — Marketing Organization
- Apr 8, 2026
Hikma — Marketing Organization
- Apr 28, 2026
Biocon Limited — Marketing Organization
Indications
Approved for
Studied for
- Acute-On-Chronic Liver Failure · Phase 3
- Acute Radiation Syndrome · Phase 1
- Allografts · Phase 3
- Anemia · Phase 2
- Anemia, Aplastic · Phase 4
- Anemia, Diamond-Blackfan · Phase 1/Phase 2
- Anemia, Hemolytic, Autoimmune · Phase 4
- Autoantibodies · Phase 4
- Blood Platelet Disorders · Phase 2
- Bone Marrow Failure Disorders · Phase 2
- Bone Marrow Transplantation · Phase 2
- Connective Tissue Diseases · Phase 4
- Cord Blood Stem Cell Transplantation · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drugs, Investigational · Phase 4
- Fanconi Anemia · Phase 2
- Granuloma · Phase 1/Phase 2
- Healthy Volunteers · Phase 4
- Hematologic Neoplasms · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 3
- Hemorrhage · Phase 2
- Hepacivirus · Phase 3
- Hepatitis B · Phase 3
- Hepatitis B virus · Phase 3
- Hepatitis C · Phase 3
- Hepatitis C, Chronic · Phase 3
- HIV · Phase 3
- HIV Infections · Phase 3
- Leukemia · Phase 2
- Leukemia, Eosinophilic, Acute · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Monocytic, Acute · Phase 2
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Phase 2
- Leukemia, Myeloid, Acute · Phase 2/Phase 3
- Leukemia, Myeloid, Chronic-Phase · Phase 2
- Leukemia, Myelomonocytic, Acute · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 2
- Liver Cirrhosis · Phase 1
- Liver Diseases · Phase 3
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Multiple Myeloma · Phase 2
- Myelodysplastic Syndromes · Phase 2
- Neoplasms · Phase 3
- Neoplasms, Connective and Soft Tissue · Phase 1
- Non-alcoholic Fatty Liver Disease · Phase 3
- Osteosarcoma · Phase 1
- Pancytopenia · Phase 2
- Peripheral Blood Stem Cell Transplantation · Phase 2
- Primary Myelofibrosis · Phase 2
- Purpura · Phase 4
- Purpura, Thrombocytopenic, Idiopathic · Phase 4
- Sarcoma · Phase 1
- Splenomegaly · Phase 2
- Therapeutics · Phase 2
- Thrombocytopenia · Phase 4
- Wiskott-Aldrich Syndrome · Phase 2
Mechanism of action
- Thrombopoietin receptorAGONIST
MPL agonist
Approval history
- approvedPriority reviewAcceleratedNov 20, 2008
Chemistry & pharmacology
SMILES
CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O.NCCO.NCCO- Mol. weight
- 564.64 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3989691 ↗
- WikipediaEltrombopag ↗
- NCATSS56D65XJ9G ↗
- ChEMBLCHEMBL6068328 ↗
- ChEMBLCHEMBL461806 ↗
- ChEMBLCHEMBL461101 ↗
Also known as
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag
- eltrombopag olamine
- eltrombopag olamine
- eltrombopag olamine
- eltrombopag olamine
- eltrombopag olamine
- eltrombopag olamine
- eltrombopagum
- ppromacta
- promacta
- promacta
- promacta
- promacta
- revolade
- revolade
- revolade
- revolade
- sb497115
- sb497115
- sb 497115
- sb-497115
- sb-497115
- sb-497 115
- sb-497115-gr
- sb-497115-gr
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07189910 | Phase 4 | Dec 1, 2025 | Huazhong University of Science and Technology |
| NCT07113743 | Phase 1/Phase 2 (Phase 2) | Sep 10, 2025 | National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT07093606 | N/A | Jul 14, 2025 | Sohag University |
| NCT06834451 | Phase 4 | Mar 1, 2025 | — |
| NCT06630221 | Phase 2 | Jan 1, 2025 | Case Western Reserve University |
| NCT06531018 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2025 | Dhaka Medical College, Renata |
| NCT06607367 | Phase 1/Phase 2 (Phase 2) | Oct 30, 2024 | Melbourne Health |
| NCT06345495 | Phase 2 | Oct 1, 2024 | Incyte, University of Texas at Houston |
| NCT06493981 | Phase 3 | Jul 31, 2024 | Assiut University |
| NCT06479291 | N/A | Jul 31, 2024 | Dr. Stanley Ho Medical Foundation, Macau, Fudan University, Government of China, Macau University of Science and Technology Hospital |
| NCT05961410 | Phase 2 | Aug 15, 2023 | National Taiwan University, Novartis |
| NCT05975996 | Phase 2 | Jul 10, 2023 | China Academy of Chinese Medical Sciences |
| NCT05907499 | Phase 3 | Jul 1, 2023 | Soochow University |
| NCT05924152 | Phase 1 | Jun 29, 2023 | Mirati Therapeutics Inc. |
| NCT05653219 | Phase 3 | Dec 30, 2022 | Novartis |
| NCT05583838 | Phase 4 | Oct 31, 2022 | China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences, Dalian Medical University, Guangzhou Medical University, Harbin Medical University, Henan Medical University, Inner Mongolia Medical University, Jiao Tong University, Kashgar 1st People's Hospital, Kunming Medical University, North China University of Science and Technology Affiliated Hospital, Shaanxi Provincial People's Hospital, Shanxi Medical University, Sunshine Lake Pharma Co., Ltd., Xijing Hospital, Xinjiang Medical University, Yuyao People's Hospital of Zhejiang Province |
| NCT05466201 | Phase 2/Phase 3 (Phase 3) | Oct 22, 2022 | Soochow University |
| NCT05438875 | Phase 2 | Jun 24, 2022 | Capital Medical University, Government of China, Peking University |
| NCT05369377 | Phase 2 | Jun 1, 2022 | Capital Medical University, Government of China, Peking University, Shandong University |
| NCT05286164 | Phase 2 | Apr 30, 2022 | Novartis, Tel Aviv University |
Organizations
Research & Development (124)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 49 | 29 | 4 | 2005 |
| Novartis | For profit | 36 | 19 | 4 | 2006 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 8 | 8 | 1 | 2009 |
| University of Texas at Houston | Academic/Hospital | 7 | 7 | 1 | 2010 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 5 | 3 | 2 | 2016 |
| Shandong University | Academic/Hospital | 5 | 3 | 2 | 2016 |
| Assiut University | Academic/Hospital | 4 | 4 | 2 | 2017 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 4 | 3 | 2 | 2018 |
| Peking University | Academic/Hospital | 4 | 4 | 2 | 2020 |
| Case Western Reserve University | Academic/Hospital | 3 | 2 | 1 | 2012 |
| Cornell University | Academic/Hospital | 3 | 3 | 1 | 2009 |
| Government of China | Government | 3 | 0 | 2 | 2022 |
| Guangzhou Medical University | Academic/Hospital | 3 | 0 | 3 | 2018 |
| Harvard University | Academic/Hospital | 3 | 2 | 3 | 2011 |
| Henan Medical University | Academic/Hospital | 3 | 0 | 2 | 2018 |
| Kunming Medical University | Academic/Hospital | 3 | 0 | 2 | 2018 |
| National Cancer Institute (NCI) | Government | 3 | 0 | 2 | 2012 |
| Soochow University | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Tel Aviv University | Academic/Hospital | 3 | 3 | 1 | 2013 |
| Associazione Qol-one | Academic/Hospital | 2 | 2 | 1 | 2011 |
Marketing (22)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Nov 28, 2017 |
| Allergan PLC (2015) | For profit | MKTG | Nov 28, 2017 |
| Amneal Pharmaceuticals | For profit | MKTG | Apr 30, 2024 |
| Amneal Pharmaceuticals | For profit | SYN | Jan 14, 2026 |
| Annora Pharma | For profit | MKTG | Apr 18, 2024 |
| Biocon Limited | For profit | MKTG | Apr 28, 2026 |
| Dr. Reddy's Laboratories | For profit | MKTG | May 7, 2025 |
| Dr. Reddy's Laboratories | For profit | SYN | Mar 16, 2026 |
| GlaxoSmithKline | For profit | NDA | Nov 20, 2008 |
| Hetero Labs Ltd | For profit | MKTG | Jul 6, 2016 |
| Hikma | For profit | MKTG | Apr 8, 2026 |
| MSN Laboratories | For profit | MKTG | Jan 14, 2026 |
| Novartis | For profit | NDA2 | Nov 20, 2008 |
| Novartis | For profit | MKTG | Nov 20, 2008 |
| Somerset Pharmaceuticals | For profit | MKTG | Jan 14, 2026 |
| Somerset Therapeutics LLC | For profit | MKTG | Aug 5, 2025 |
| Teva | For profit | SYN | Oct 3, 2022 |
| Teva | For profit | MKTG | Feb 16, 2018 |
| Teva | For profit | NDA2 | Oct 3, 2022 |
| Teva | For profit | SYN | Nov 29, 2023 |
| ZENARA | For profit | MKTG | Apr 8, 2026 |
| Zydus Discovery DMCC | For profit | MKTG | Jan 14, 2026 |