Data updated: May 26, 2026
FLUDARA (fludarabine phosphate)
Trial Activity: Growth 4 active trials
Oncology
Approved 1991-04-18
Development Insights
Baylor College of Medicine conducting 2 trials (40%)
6 indications explored (Moderate)
→ neuroblastoma (1 trials)
→ liver cancer (1 trials)
→ cancer (1 trials)
2
Indications
--
Phase 3 Trials
2
Priority Reviews
35
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1991-04-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FLUDARA Approval History
1992
1993
1994
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1996
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1999
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2002
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2005
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2021
2022
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2026
Original
New Indication
New Form
Label Update
23 FDA actions from 1991 to 2010 · 1 indication expansions
Jul 2002 SUPPL Priority
Mfg
May 2002 SUPPL Priority
Mfg
Mar 2002 SUPPL Priority
Mfg
Mar 2000 SUPPL Priority
Mfg
May 1999 SUPPL Priority
Label
Sep 1996 SUPPL Priority
Mfg
Jan 1996 SUPPL Priority
Mfg
Sep 1994 SUPPL Priority
Label
May 1993 SUPPL Priority
Mfg
Jan 1993 SUPPL Priority
Mfg
Oct 1992 SUPPL Priority
Label
Apr 1992 SUPPL Priority
Label
Dec 1991 SUPPL Priority
Mfg
Apr 1991 ORIGINAL Priority
New Drug
What FLUDARA Treats
2 FDA approvalsOriginally approved for its first indication in 1991 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
157 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06904066 | 10002088 002088-C | Ph 1 | recruiting | Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies |
| NCT04539366 | NCI-2020-06646 NCI-2020-06646, PED-CITN-02 | Ph 1 | suspended | Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial |
| NCT06066359 | 2023-0171 NCI-2023-08318 | Ph 1, Ph 2 | recruiting | Ph I/II Trial of Cord Blood-derived NK Cells With NY-ESO-1 TCR/IL-15 for R/R Myeloma |
| NCT07582172 | 25663 NCI-2026-03208, 25663 | Ph 2 | not yet recruiting | Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome |
| NCT06043323 | 2023-0087 NCI-2023-07173 | Ph 2 | recruiting | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma |
| NCT05092451 | 2021-0386 NCI-2021-12093 | Ph 1, Ph 2 | recruiting | Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances |
| NCT02727803 | 2015-0313 NCI-2016-00584, 2015-0313 | Ph 2 | recruiting | Personalized NK Cell Therapy in CBT |
| NCT03670966 | RG1003349 10060, P30CA015704 | Ph 1, Ph 2 | recruiting | 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome |
| NCT02048813 results posted | NCI-2014-00118 NCI-2014-00118, E1912 | Ph 3 | active not recruiting | Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT01231412 results posted | 2448.00 NCI-2010-02035, 2448.00 | Ph 3 | completed | Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant |
| NCT05955261 | AML23 NCI-2023-04138 | Ph 2 | suspended | A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia |
| NCT05761171 | AALL2121 NCI-2023-00503, AALL2121 | Ph 2 | active not recruiting | A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia |
| NCT06083883 | 2023-0289 NCI-2023-08752 | Ph 1 | recruiting | Phase I/Ib Study of NK Expressing an Affinity-enhanced T-cell Receptor (TCR) Against the NY-ESO-1 |
| NCT05470283 | 2022-0356 NCI-2022-06873 | Ph 1 | active not recruiting | Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma |
| NCT06066424 | 2023-0161 NCI-2023-08351 | Ph 1 | recruiting | Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA) |
| NCT02250937 | 2014-0431 NCI-2014-02324, 2014-0431 | Ph 2 | active not recruiting | Venetoclax and Sequential Busulfan, Cladribine, and Fludarabine Phosphate Before Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome |
| NCT01955460 | 2012-0758 NCI-2014-01211, RP110553-P4 | Ph 1 | active not recruiting | Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma |
| NCT06434363 | 2024-0208 NCI-2024-04434 | Ph 1, Ph 2 | recruiting | Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders |
| NCT03192397 results posted | I 44417 NCI-2017-01069, I 44417 | Ph 1, Ph 2 | active not recruiting | Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant |
| NCT01822652 GRAIN | H-31493 GRAIN P01CA094237 | Ph 1 | active not recruiting | 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN |
| NCT02333162 | IRB14-0709 NCI-2014-02469, IRB14-0709 | Ph 1 | suspended | Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant |
| NCT02251821 results posted | 9033 NCI-2014-01882, 9033 | Ph 2 | completed | JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis |
| NCT06871410 | I-3916824 NCI-2025-01523, I-3916824 | Ph 1 | recruiting | Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04119024 | IRB-77842 NCI-2019-05764 | Ph 1 | recruiting | Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors |
| NCT04579523 | RG1121028 NCI-2020-06835, 10467 | Ph 1 | not yet recruiting | ²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Transplant for the Treatment of Newly Diagnosed, Recurrent, or Refractory High-Risk Multiple Myeloma |
| NCT05767359 | 22-546 | Ph 2 | active not recruiting | CAR- PRISM (PRecision Intervention Smoldering Myeloma) |
| NCT03980769 | RG1005072 NCI-2019-03243, 9621 | Ph 2 | recruiting | Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders |
| NCT06345495 | 2023-0899 NCI-2024-02814 | Ph 2 | recruiting | High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly |
| NCT04965597 | BMTCTN1904 2U10HL069294-11, RG1121820 | Ph 2 | completed | Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) |
| NCT02629809 | 2015-0281 NCI-2016-00016, 2015-0281 | Ph 2 | active not recruiting | Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia |
| NCT05703854 | 2021-0443 NCI-2023-00469 | Ph 1, Ph 2 | recruiting | Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma |
| NCT04205838 | 19-000604 NCI-2019-02887, 19-000604 | Ph 2 | terminated | Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma |
| NCT05672459 | 2022-0261 NCI-2023-00020 | Ph 1, Ph 2 | active not recruiting | A Safety And Efficacy Study Of HLA-G- Targeted CAR-T Cells IVS-3001 In Subjects With Previously Treated Advanced HLA-G-Positive Solid Tumors |
| NCT04708054 | 2020-0790 NCI-2020-13919, 2020-0790 | Ph 2, Ph 3 | recruiting | Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS |
| NCT02861417 | 2016-0137 NCI-2017-00614, 2016-0137 | Ph 2 | active not recruiting | Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant |
| NCT05110742 | 2021-0526 NCI-2021-10898 | Ph 1, Ph 2 | recruiting | Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances |
| NCT04262843 | 19518 NCI-2019-08984, 19518 | Ph 2 | active not recruiting | Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia |
| NCT05040568 | 2021-0076 NCI-2021-09411 | Ph 1 | completed | A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD) |
| NCT06013423 | RG1123652 NCI-2023-05598, FHIRB0020219 | Ph 2 | recruiting | Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases |
| NCT06358430 | 2023-1017 NCI-2024-03107 | Ph 1 | recruiting | Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) |
| NCT03277729 results posted | 9738 NCI-2017-01595, 9738 | Ph 1, Ph 2 | active not recruiting | A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas |
| NCT06383572 | 2024-0196 NCI-2024-03505 | Ph 1, Ph 2 | recruiting | Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies |
| NCT03128034 | 9595 NCI-2017-00452, 9595 | Ph 1, Ph 2 | recruiting | 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia |
| NCT05115630 results posted | 2021-0329 NCI-2021-12094 | Ph 2 | completed | Off-the-shelf NK Cells + SCT for Myeloid Malignancies |
| NCT01697527 | 12-000153 NCI-2012-01548 | Ph 2 | active not recruiting | Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies |
| NCT03233854 | IRB-41382 NCI-2017-01291 | Ph 1 | active not recruiting | CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells With or Without NKTR-255 in Adults With Recurrent or Refractory B Cell Malignancies |
| NCT06550141 | 24-317 | Ph 2 | recruiting | Emapalumab Prevention of CAR-T Cell Associated Toxicities |
| NCT05400122 | CASE6Y21 | Ph 1 | suspended | Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer |
| NCT01760655 results posted | 12D.501 JT 2977 | Ph 2 | completed | Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk Hematologic Malignancies |
| NCT02153580 | 13351 NCI-2014-01168, 114025 | Ph 1 | active not recruiting | Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia |
Showing 50 of 157 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
FLUDARA 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