Data updated: Nov 8, 2026
DEPOCYT (cytarabine) · PACIRA PHARMS INC
Oncology
Approved 1999-04-01
2
Indications
--
Phase 3 Trials
1
Priority Reviews
27
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1999-04-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE, LIPOSOMAL
DEPOCYT Approval History
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
17 FDA actions from 1999 to 2017 · 1 indication expansions
Jan 2017 SUPPL
Mfg · Manufacturing (CMC)
Sep 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Aug 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Mar 2015 SUPPL Priority
Mfg
Aug 2014 SUPPL Priority
Mfg
Apr 2014 SUPPL Priority
Mfg
Aug 2013 SUPPL Priority
Mfg
Dec 2002 SUPPL Priority
Mfg
Mar 2001 SUPPL Priority
Mfg
Jan 2001 SUPPL Priority
Mfg
What DEPOCYT Treats
2 FDA approvalsOriginally approved for its first indication in 1999 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
508 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03983824 | NCI-2019-03607 NCI-2019-03607, PHI-103 | Ph 1 | active not recruiting | Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia |
| NCT05886049 | NCI-2023-04141 NCI-2023-04141, OSU 23228 | Ph 1 | recruiting | A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease |
| NCT04530565 | NCI-2020-06381 NCI-2020-06381, EA9181 | Ph 3 | active not recruiting | Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults |
| NCT06635681 DAV-AML-2024 | IIT2024074 | Ph 2 | recruiting | Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML |
| NCT06744556 | IIT2024095 | Ph 2 | active not recruiting | HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML |
| NCT05564390 | NCI-2022-07006 NCI-2022-07006, MYELOMATCH | Ph 2 | recruiting | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) |
| NCT06124157 | NCI-2023-09214 NCI-2023-09214, AALL2131 | Ph 2 | recruiting | A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT04687761 | VEN-A-QUI | Ph 1, Ph 2 | completed | Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old |
| NCT06504199 ZGR | IIT2024010 | Ph 2 | active not recruiting | Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma |
| NCT05554393 | NCI-2022-07534 NCI-2022-07534, AL.6 | Ph 2 | recruiting | Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) |
| NCT03808610 | 2016-0629 NCI-2018-03360, 2016-0629 | Ph 1, Ph 2 | terminated | Low-Intensity Chemotherapy and Venetoclax in Treating Patients With Relapsed or Refractory B- or T-Cell Acute Lymphoblastic Leukemia |
| NCT06561880 FLT3AML-2024 | IIT2024055 | Ph 1, Ph 2 | recruiting | The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation |
| NCT07444710 | NCI-2026-01137 NCI-2026-01137, PHI-158 | Ph 1 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma |
| NCT05554406 | NCI-2022-07535 NCI-2022-07535, MM1YA-S01 | Ph 2 | recruiting | Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial) |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT04801797 | 21-113 | Ph 2 | active not recruiting | Venetoclax + Azacitidine vs. Induction Chemotherapy in AML |
| NCT03286634 | ASIA-DS-ALL-2016 | Ph 2 | active not recruiting | ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT05453903 | CR109124 75276617ALE1002, 2021-003999-14 | Ph 1 | active not recruiting | A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies |
| NCT07428486 | 2025-1676 NCI-2026-01274 | Ph 1 | withdrawn | A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia |
| NCT06034470 | RG1123378 NCI-2023-03572, FHIRB0020122 | Ph 1 | active not recruiting | Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms |
| NCT04043494 LBL 2018 | UKM17_0023 2017-001691-39 | Ph 3 | recruiting | International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma |
| NCT07498465 | PEPN2513 NCI-2026-01768, PEPN2513 | Ph 1 | withdrawn | A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia |
| NCT04293562 | AAML1831 NCI-2020-00546, AAML1831 | Ph 3 | recruiting | A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations |
| NCT05146739 results posted | NCI-2021-10020 NCI-2021-10020, PEPN2113-APAL2020C | Ph 1 | active not recruiting | Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory That Expresses E-selectin Ligand on the Cell Membrane |
| NCT04115631 | EA4181 NCI-2019-05536, EA4181 | Ph 2 | active not recruiting | A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma |
| NCT04217278 COSI | RG_17-234 | Ph 2, Ph 3 | active not recruiting | A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT |
| NCT03182244 results posted | 2215-CL-0303 CTR20170326 | Ph 3 | completed | A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation |
| NCT03959085 | AALL1732 NCI-2019-02845, AALL1732 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy |
| NCT02112916 results posted | NCI-2014-00712 NCI-2014-00712, s14-01925 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma |
| NCT02101853 results posted | NCI-2014-00631 NCI-2014-00631, s15-00970 | Ph 3 | active not recruiting | Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia |
| NCT03914625 | NCI-2019-02187 NCI-2019-02187, AALL1731 | Ph 3 | active not recruiting | A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia |
| NCT02883049 results posted | NCI-2011-03797 NCI-2011-03797, S12-01254 | Ph 3 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations |
| NCT02981628 | AALL1621 NCI-2016-01494, AALL1621 | Ph 2 | active not recruiting | Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia |
| NCT02443077 results posted | NCI-2015-00668 NCI-2015-00668, BMT CTN 1201 | Ph 3 | active not recruiting | Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
| NCT06177067 | RAVAML NCI-2023-10509 | Ph 1 | recruiting | Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT03007147 | AALL1631 NCI-2016-01588, 2024-515499-12-00 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT02003222 results posted | NCI-2013-02229 NCI-2013-02229, ECOG-E1910 | Ph 3 | active not recruiting | Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia |
| NCT06289673 | INITIALL NCI-2024-01659 | Ph 4 | recruiting | Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma |
| NCT06390319 | SJALL23T NCI-2024-03015 | Ph 2 | recruiting | Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL) |
| NCT06533748 | SJALL23H NCI-2024-06013 | Ph 2 | recruiting | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma |
| NCT03206671 B-NHL 2013 | UKM12_0020 2013-003253-21 | Ph 3 | active not recruiting | Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents |
| NCT03964090 | 190103 19-C-0103 | Ph 2 | active not recruiting | Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, and Rituximab (TEDDI-R) in Aggressive B-cell Lymphomas With Secondary Involvement of the Central Nervous System (CNS) |
| NCT06497062 | BGB-11417-2001-IIT | Ph 2 | active not recruiting | Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia |
| NCT00558519 results posted | CALGB-10403 CALGB-10403, ECOG C10403 | Ph 2 | completed | Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia |
| NCT05183035 | ITCC-101/APAL2020D 2021-003212-11, 2023-510160-12-00 | Ph 3 | active not recruiting | Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) |
| NCT04898894 | SELCLAX NCI-2021-03435 | Ph 1 | active not recruiting | Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia |
| NCT06917911 | NCI-2025-02426 NCI-2025-02426, MM1YA-A04 | Ph 2 | recruiting | Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial) |
| NCT03591510 | CPKC412A2218 2017-004830-28 | Ph 2 | active not recruiting | A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML |
Showing 50 of 508 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.
DEPOCYT FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.