Eltrombopag
Small molecule targets MPL via activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ELTROMBOPAG | — | 2026-03-16 | fda.gov ↗ |
| Approved | EU (EMA) | Revolade | — | 2010-03-11 | europa.eu ↗ |
Trials 127 · started per year
Also used as a comparator or background therapy in 27 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05924152 Comparator | Jun → Aug 2023 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00903422 Comparator | May 2009 → Jun 2012 | myelodysplastic syndrome | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00833378 Comparator | Jan → Mar 2009 | hepatitis C virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07113743 Background | Sep 2025 → Sep 2028 expected | granulomatous disease, chronic, X-linked | National Institute of Allergy and Infectious Diseases (NIAID) | Enrolling by invitation | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07660172 Background | Feb 2027 → Apr 2033 expected | autoimmune thrombocytopenia | Novartis Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07687134 Background | Jul 2026 overdue | thrombocytopenia due to immune destruction | Institute of Hematology & Blood Diseases Hospital, China | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07669675 Background | Jul 2026 → Dec 2027 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07421167 Background | Jun 2026 → Apr 2028 expected | Evans syndrome | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06345495 Background | Oct 2024 → Jan 2027 expected | myelofibrosis, splenic disorder | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT01880047 Comparator | Feb 2013 → Feb 2017 | autoimmune thrombocytopenia, platelet disorder, undefined | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT01147809 Comparator | Jun 2010 → Jan 2015 | thrombocytopenia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00110799 Comparator | Apr 2005 → Oct 2006 | chronic hepatitis C virus infection, thrombocytopenia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00102726 Comparator | Feb 2005 → Feb 2007 | thrombocytopenia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07001397 Comparator | Jun 2025 → Mar 2026 overdue | aplastic anemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05907499 Background | Jul 2023 → Jul 2026 overdue | — | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05653219 Background | Feb 2023 → Jun 2025 overdue | primary thrombocytopenia | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01433978 Comparator | Mar 2012 → Sep 2013 | autoimmune thrombocytopenic purpura | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00678587 Comparator | Jun 2008 → Oct 2009 | HIV infectious disease, hepatitis B virus infection, hepatitis C virus infection, metabolic dysfunction-associated steatohepatitis +1 | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT05718856 Comparator | Feb 2023 → May 2025 | primary thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 4 | NCT05583838 Comparator | Nov 2022 → Feb 2024 | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT04518475 Comparator | Aug 2020 → Feb 2029 expected | autoimmune thrombocytopenia | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 4 | NCT03771378 Comparator | Jan 2019 → May 2020 | autoimmune thrombocytopenia | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 4 | NCT03243656 Comparator | Dec 2017 → Dec 2019 | — | Assiut University | Completed | No outcome recorded |
| Phase 4 | NCT01055600 Background | Mar 2013 → Jul 2014 | thrombocytopenia | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06790888 Comparator | Feb 2025 → Dec 2027 expected | autoimmune thrombocytopenia | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| — | NCT06479291 Background | Jul 2024 → Jan 2026 overdue | autoimmune thrombocytopenia | Yunfeng Cheng | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04837703 Background | — | thrombocytopenia | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 12 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-12-02 | Novartis Pharmaceuticals | Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies novartis.com ↗ |
| 2018-11-16 | Novartis Pharmaceuticals | FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication novartis.com ↗ |
| 2018-05-30 | Novartis Pharmaceuticals | FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA) novartis.com ↗ |
| 2018-01-04 | Novartis Pharmaceuticals | Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA) novartis.com ↗ |
| 2017-10-18 | Novartis Pharmaceuticals | Novartis drug Revolade® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP) novartis.com ↗ |
| 2017-04-19 | Novartis Pharmaceuticals | NIH study in NEJM shows Novartis drug eltrombopag as first-line therapy with standard treatment improves responses in severe aplastic anemia novartis.com ↗ |
| 2016-06-10 | Novartis Pharmaceuticals | Novartis highlights long-term safety data of Revolade® in adults with chronic immune thrombocytopenia, a rare blood disorder novartis.com ↗ |
| 2016-04-07 | Novartis Pharmaceuticals | Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP novartis.com ↗ |
| 2015-09-02 | Novartis Pharmaceuticals | Novartis receives EU approval for new Revolade® use as first-in-class therapy for patients with severe aplastic anemia novartis.com ↗ |
| 2015-08-24 | Novartis Pharmaceuticals | FDA expands use of Novartis drug Promacta® to include treatment of children ages 1 and older with chronic immune thrombocytopenia novartis.com ↗ |
| 2015-07-24 | Novartis Pharmaceuticals | Novartis drug Revolade® recommended by CHMP for EU approval to treat patients with severe aplastic anemia, a serious blood disorder novartis.com ↗ |
| 2015-06-11 | Novartis Pharmaceuticals | Novartis gains FDA approval for Promacta® providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder novartis.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 158 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eltrombopag | “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 ↗149“The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding.” NCT03119974 ↗ “This study aims to identify patient characteristics that predict effective eltrombopag dosage for the treatment of Hepatitis C virus (HCV)-related thrombocytopenia.” PMID 26173631 ↗ Oct 2015 “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 ↗ “Thrombopoietin mimetic (Eltrombopag) was firstly FDA approved for treatment of immune thrombocytopenic purpura.” NCT03896971 ↗ “Three TPO-RAs could be used in this study, including eltrombopag, hetrombopag and avatrombopag.” NCT05718856 ↗ “Eltrombopag (Promacta ), an oral 2nd generation small molecule TPO-agonist” NCT01623167 ↗ “The starting dose of eltrombopag is 50-75mg once daily.” NCT04915482 ↗ “Eltrombopag: initial dose 50mg/d, maximum dose 150mg/d” NCT07523009 ↗ “Eltrombopag 50mg/d, increased by 25mg every two weeks” NCT07558434 ↗ “eltrombopag” NCT07421167 ↗ |
| Known as | ELT | “Eltrombopag (ELT)” NCT01957176 ↗ |
| Known as | ELTR | “We compared the efficacy and safety of eltrombopag (ELTR) combined with immunosuppressive therapy (IST) and IST alone in treatment-naïve children with severe (SAA) and very...” PMID 35446936 ↗ Mar 2023 |
| Known as | Eltrombopag (EPAG) | “Eltrombopag (EPAG)” NCT07558434 ↗ |
| Known as | Eltrombopag olamine | “Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with...” NCT02158936 ↗6“Eltrombopag tablets will be white, round film coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg and 75 mg of eltrombopag.” NCT02201290 ↗ “An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)” NCT00424177 ↗ “eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist” NCT00370331 ↗ “Drug: Eltrombopag olamine” NCT01147809 ↗ “Drug: Eltrombopag olamine” NCT01098487 ↗ “Drug: Eltrombopag Olamine” NCT01428635 ↗ |
| Known as | EPAG | “Eltrombopag (EPAG) received approval from the US Food and Drug Administration for the treatment of refractory severe aplastic anemia (rSAA) based on treatment of 43 patients...” PMID 30992268 ↗ Apr 20193“Eltrombopag (EPAG), a small molecule thrombopoietin mimetic, has previously been shown to result in durable multi-lineage hematologic responses with low toxicity in patients...” PMID 32330244 ↗ Apr 2020 “eltrombopag (EPAG)/hetrombopag (HPAG)” NCT07523009 ↗ “Eltrombopag (EPAG)” NCT06630221 ↗ |
| Known as | EPAG-pfos | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07001397 ↗ |
| Known as | PROMACTA | “This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®).” NCT01055600 ↗ |
| Known as | Revolade | “An Open-label Single-dose Pharmacokinetic Study of an Oral Formulation in Tablets Containing Eltrombopag 50 mg (Revolade, Glaxosmithkline Mexico, S.A. De C.V.) in Healthy...” NCT02254434 ↗6“Eltrombopag (Revolade) is a thrombopoietin receptor agonist indicated for the treatment of adult patients with ITP relapsed/refractory to splenectomy” NCT01791101 ↗ “Administration of Eltrombopag (Revolade®), 50 mg PO, from day 5-140.” NCT04812483 ↗ “Drug: Eltrombopag/Revolade” NCT02928419 ↗ “Eltrombopag (Revolade®)” NCT06607367 ↗ “Revolade (eltrombopag)” NCT01488565 ↗ “Eltrombopag/Revolade” NCT02912208 ↗ |
| Known as | Revolade (eltrombopag) | “Revolade (eltrombopag)” NCT01488565 ↗1“Revolade (eltrombopag)” NCT01500538 ↗ |
| Known as | SB-497115 | “SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy” NCT00102726 ↗ |
| Known as | SB-497115-GR | “Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with...” NCT02158936 ↗6“A Longitudinal 2-year Bone Marrow Study of Eltrombopag Olamine (SB-497115-GR) in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)” NCT01098487 ↗ “An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP)” NCT00424177 ↗ “Eltrombopag was provided as white round film-coated tablets containing 12.5 mg or 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag).” NCT02404025 ↗ “White, round, film-coated tablets containing 12.5 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet” NCT02148133 ↗ “eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist” NCT00370331 ↗ “Eltrombopag (SB-497115-GR)” NCT01147809 ↗ |
| Action | Activate | “activates the thrombopoietin receptor” NCT00102726 ↗ |
| Modality | Small molecule | “eltrombopag, an oral, nonpeptide, thrombopoietin receptor agonist” PMID 23497336 ↗ Mar 2013 |
| Route | Oral | “administered orally daily on days 2 through 11 for each 21-day cycle” NCT00102726 ↗ |
| Target | MPL | “Thrombopoietin Receptor (MPL) Agonist Eltrombopag.” NCT00888901 ↗ |