Data updated: Nov 8, 2026
ELTROMBOPAG · Dr. Reddy's
Trial Activity: Declining 12 active trials
Other
Approved 2026-03-16
Development Insights
Novartis Pharmaceuticals conducting 14 trials (17%)
69 indications explored (Broad Platform)
→ thrombocytopenia (16 trials)
→ severe aplastic anemia (4 trials)
→ leukemia (4 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2026-03-16
- Routes
- N/A
- Dosage Forms
- TABLET
ELTROMBOPAG Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Mar 2026 ORIGINAL
Update
What ELTROMBOPAG Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2026) New
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Clinical Trial Registry
82 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07113743 | 10000186 000186-I | Ph 1, Ph 2 | enrolling by invitation | Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease |
| NCT05653219 VAYHIT2 | CVAY736Q12301 2024-512890-28-00 | Ph 3 | active not recruiting | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids |
| NCT04518475 | IIT2020011 | Ph 4 | recruiting | Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults |
| NCT02099747 RACE | EBMT-RACE 2014-000363-40 | Ph 3 | completed | hATG+CsA vs hATG+CsA+Eltrombopag for SAA |
| NCT01328587 results posted | 110134 11-H-0134 | Ph 2 | completed | Eltrombopag for Moderate Aplastic Anemia |
| NCT04797000 | CETB115L11201 | Ph 2 | active not recruiting | Study of Efficacy and Safety of Eltrombopag in Lower-risk MDS Patients With Platelet Transfusion Dependence |
| NCT06345495 | 2023-0899 NCI-2024-02814 | Ph 2 | recruiting | High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly |
| NCT04304820 results posted | 200033 20-H-0033 | Ph 2 | recruiting | Early Initiation of Oral Therapy With Cyclosporine and Eltrombopag for Treatment Naive Severe Aplastic Anemia (SAA) |
| NCT03664518 | IIT2018006 | Ph 2 | completed | to Evaluate the Efficacy and Safety of Eltrombopag for Immune Thrombocytopenia With Chronic HBV Infection |
| NCT04328727 REACTS results posted | CETB115G2201 2024-000602-14 | Ph 2 | completed | Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia |
| NCT03988608 results posted | CETB115E2202 | Ph 2 | completed | Study Assessed the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects. |
| NCT03948529 REGALIA | 2017_52 2018-001157-27 | Ph 2 | terminated | RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation |
| NCT07189910 | ITP-TPO+Eltro | Ph 4 | not yet recruiting | Sequential rhTPO and Eltrombopag Following Glucocorticoids for Severe Adult ITP |
| NCT05438875 | 2022-1-4082 | Ph 3 | completed | The Combination of ATRA and Eltrombopag as the Treatment of Steroid-resistant/Relapse ITP Based on MSC-C5b-9 |
| NCT03206086 results posted | 170121 17-H-0121 | Ph 2 | active not recruiting | Eltrombopag for Fanconi Anemia |
| NCT03939637 results posted | H-42131 ICON 3 CETB115JUS33T, ICON 3 | Ph 3 | completed | Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children |
| NCT02773225 EMAA | 9345 | Ph 2, Ph 3 | completed | Efficacy and Safety of Eltrombopag + CSA in Patients With Moderate Aplastic Anemia (EMAA) |
| NCT04346654 XPAG-ITP results posted | CETB115JDE01 2019-002658-21 | Ph 2 | completed | A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP |
| NCT04269889 results posted | 200021 20-H-0021 | Ph 1, Ph 2 | completed | Treatment of Refractory Diamond-Blackfan Anemia With Eltrombopag |
| NCT05583838 TE-ITP | IIT2022037 | Ph 4 | completed | A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts |
| NCT04485416 CCPO011 | 1602666 150124, CCPO011 | Ph 1 | terminated | Pilot Trial of Eltrombopag in Patients Undergoing Chemotherapy for Malignant Solid Tumors |
| NCT03844360 | Antineoplastic Drugs001 | Ph 4 | recruiting | Dose Individualization of Antineoplastic Drugs and Anti-Infective Drug in Children With Hematoplastic Disease |
| NCT04542382 BCRPmarker | 20-30638 | Ph 1 | completed | Identification and Validation of Biomarkers for Breast Cancer Resistance Protein (BCRP) |
| NCT03025698 results posted | CETB115E2201 2015-003166-91 | Ph 2 | completed | A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia |
| NCT04600960 | IIT2020014（Eltrombopag） | Ph 2 | recruiting | Eltrombopag for Chemotherapy-induced Thrombocytopenia |
| NCT03524612 TAPER results posted | CETB115J2411 2018-000452-18 | Ph 2 | completed | A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP |
| NCT03603795 EPAG2015 | EPAG 2015 | Ph 2 | active not recruiting | Study Impact on Outcome of Eltrombopag in Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy |
| NCT03638817 ELPOT | RC31/16/8913 2017-004489-88 | Ph 2 | completed | Perioperative Eltrombopag in Patients With Inherited Thrombocytopenia |
| NCT06493981 | Noha Mahmoud Muhammed | Ph 3 | not yet recruiting | Outcomes in Bone Marrow Aplasia. |
| NCT02446145 DELTA | TUD-DELTA1-063 2014-003150-13 | Ph 2 | terminated | A Randomized Placebo-controlled Phase 2 Study of Decitabine With or Without Eltrombopag in AML Patients |
| NCT03718533 ELTION results posted | CETB115EES03 2018-001129-15 | Ph 2 | terminated | Study of Efficacy and Safety of Eltrombopag in Patients With Poor Graft Function |
| NCT03830749 | HHRC_ITP | Ph 2 | completed | Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura |
| NCT02998645 SOAR results posted | CETB115E2403 2016-002814-29 | Ph 2 | completed | Eltrombopag Combined With Cyclosporine as First Line Therapy in Patients With Severe Acquired Aplastic Anemia |
| NCT00961064 results posted | 090199 09-H-0199 | Ph 2 | completed | A Pilot Study of a Thrombopoietin-Receptor Agonist, Eltrombopag, in Patients With Low to Int-2 Risk Myelodysplastic Syndrome (MDS) |
| NCT04917679 | Eltrombopag-Diacerein ITP | Ph 2 | completed | Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP |
| NCT06045052 | FANCREV | Ph 2 | completed | Eltrombopag for Treatment of Fanconi Anemia |
| NCT01000051 results posted | 2009-0106 NCI-2011-01099 | Ph 2 | completed | Eltrombopag for Post Transplant Thrombocytopenia |
| NCT01891994 results posted | 130133 13-H-0133, NCT01891994 | Ph 2 | completed | Extended Dosing With Eltrombopag for Severe Aplastic Anemia |
| NCT01168921 results posted | 2010-0123 NCI-2012-01905 | Ph 2 | completed | Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL) |
| NCT01286038 | MCC-16523 | Ph 1 | terminated | Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia |
| NCT03515096 | 201803070044 | Ph 3 | completed | Eltrombopag vs. rhTPO to Increase Platelet Level After HSCT |
| NCT03243656 Eltroplastic | MAAhmed | Ph 4 | completed | Eltrombopag & Cyclosporine in Children With Sever Aplastic Anemia |
| NCT02402998 | ITP0815 2015-001327-23 | Ph 2 | completed | Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia |
| NCT01113502 results posted | UPCC 17409 | Ph 1, Ph 2 | terminated | Eltrombopag in Elderly Acute Myelogenous Leukemia (AML) |
| NCT01791101 ITP0511 | ITP0511 2011-004608-39 | Ph 2 | completed | Eltrombopag in Patients With Delayed Post Transplant Thrombocytopenia. |
| NCT02323178 | GFM-LMMC-Eltrombopag 2013-001779-19 | Ph 1, Ph 2 | completed | A Study of Eltrombopag in Patients With CMML and Thrombocytopenia |
| NCT00922883 results posted | 090154 09-H-0154 | Ph 2 | completed | A Pilot Study of the Thrombopoietin-Receptor Agonist Eltrombopag in Refractory Aplastic Anemia Patients |
| NCT01621204 | M-EIBS-A-12 | Ph 3 | completed | A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients |
| NCT01893372 results posted | 2013-0225 NCI-2013-02252 | Ph 2 | completed | Eltrombopag With or Without Hypomethylating Agent After Hypomethylating Agent Failure For Patients With Myelodysplastic Syndrome (MDS) |
| NCT02010645 results posted | 2013-0590 NCI-2014-01276 | Ph 2 | terminated | Eltrombopag With Decitabine in Advanced Myelodysplastic Syndrome (MDS) |
Showing 50 of 82 trials
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Pro Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELTROMBOPAG FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment