TheraRadar
Data updated: May 26, 2026

BORTEZOMIB

Oncology Approved 2017-11-06
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-11-06
Patent Cliff
2042

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Patent cliff and revenue data

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Routes
INTRAVENOUS, INTRAVENOUS, SUBCUTANEOUS, INJECTION
Dosage Forms
POWDER, INJECTABLE, SOLUTION

Companies

Fresenius Kabi PHARMOBEDIENT MAIA PHARMS INC ACCORD HLTHCARE Pfizer Teva SCINOPHARM TAIWAN VILIN BIO MED GLAND Apotex PHARMASCIENCE INC JIANGSU HANSOH PHARM Baxter Dr. Reddy's QILU PHARM HAINAN EUGIA PHARMA MSN RELIANCE LIFE SCI SHILPA CAPLIN ONE LABS HETERO LABS LTD VI SHUANGCHENG ZYDUS PHARMS MEITHEAL
Active Ingredient: BORTEZOMIB

BORTEZOMIB Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
37 FDA actions from 2017 to 2026 · 2 indication expansions
Jan 2026 ORIGINAL
Update
FDA Letter
Dec 2025 ORIGINAL
Update
Jun 2025 ORIGINAL
Update

What BORTEZOMIB Treats

15 FDA approvals

Originally approved for its first indication in 2017 . Covers 15 distinct patient populations.

  • Other (15)
📋

Clinical Trial Registry

369 trials
Trial Sponsor ID Phase Status Title
NCT01009840 results posted 273-08-205 Ph 2 completed IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
NCT06169215 NCI-2023-07073 NCI-2023-07073, 10612 Ph 2 active not recruiting Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
NCT05514990 16M-22-1 NCI-2022-06505, 16M-22-1 Ph 1, Ph 2 active not recruiting Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial
NCT06152575 C1071032 MAGNETISMM-32, 2023-507871-23-00 Ph 3 recruiting MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
NCT05849610 GEM-TECTAL GEM-TECTAL Ph 2 active not recruiting Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
NCT04181827 CARTITUDE-4 results posted CR108695 68284528MMY3002, 2019-001413-16 Ph 3 active not recruiting A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
NCT05083169 MajesTEC-3 CR109049 64007957MMY3001, 2020-004742-11 Ph 3 active not recruiting A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT04923893 CARTITUDE-5 CR109015 68284528MMY3004, 2021-001242-35 Ph 3 active not recruiting A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy
NCT07222761 LINKER-MM5 R5458-ONC-2246 2024-519504-27-00 Ph 3 recruiting A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
NCT06577025 aMMbition 54767414MMY2093 54767414MMY2093, 2023-505792-71-00 Ph 2 active not recruiting A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
NCT04722146 MajesTEC-2 CR108927 64007957MMY1004, 2020-004404-33 Ph 1 active not recruiting A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
NCT00720785 080186 08-H-0186 Ph 1 completed Natural Killer Cells and Bortezomib to Treat Cancer
NCT06413498 iMMagine-3 KT-US-679-0788 2024-511188-26, jRCT2043240170 Ph 3 recruiting A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
NCT06022939 S2213 NCI-2023-04234, S2213 Ph 3 recruiting Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis
NCT04566328 EAA181 NCI-2020-06647, EAA181 Ph 3 recruiting Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial
NCT05623020 MagnetisMM-6 C1071006 MAGNETISMM-6, 2024-514139-50-00 Ph 3 recruiting A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
NCT06348147 LCCC2323 Ph 2 suspended Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
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
NCT02343042 STOMP KCP-330-017 Ph 1, Ph 2 active not recruiting Selinexor and Backbone Treatments of Multiple Myeloma Patients
NCT03319667 IMROZ EFC12522 U1111-1194-2121, 2024-514417-34 Ph 3 active not recruiting A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
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)
NCT05519085 SUCCESSOR-1 CA057-001 2023-509859-13 Ph 3 recruiting A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT07391657 DURGA-4 D8311C00001 AZD0120 Ph 3 recruiting A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
NCT07227311 224317 2025-523117-28-00 Ph 2 recruiting A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)
NCT01668719 results posted S1211 NCI-2012-01998, PS1211_A12PAMDREVW01 Ph 1, Ph 2 completed S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
NCT02783625 16-042 Ph 1 completed Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas
NCT06868654 DREAMM 7 results posted 207503-CHN Ph 3 active not recruiting China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
NCT06868667 DREAMM 7 results posted 207503-JPN Ph 3 active not recruiting Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
NCT03945591 results posted 18-01185 Ph 2 completed High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
NCT04246047 DREAMM 7 results posted 207503 2023-510537-28-00 Ph 3 active not recruiting Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
NCT05392946 MC200807 21-006604 Ph 1, Ph 2 active not recruiting Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study
NCT07513129 2025-1869 NCI-2026-02416 Ph 1 not yet recruiting Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma
NCT05848687 IRB-68271 PEDSHEMALL0015, NCI-2023-04129 Ph 1, Ph 2 recruiting TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT04166565 EMN19 EMN19 2019-000991-41 Ph 2 active not recruiting Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease
NCT04996160 IRB-60392 NCI-2021-09313 Ph 1 completed Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
NCT06083922 22-424 Ph 2 recruiting A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
NCT03763162 2018-0512 NCI-2018-02830, 2018-0512 Ph 2 active not recruiting Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT02719613 CA204-185 2016-000037-51 Ph 2 completed Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating Elotuzumab
NCT01695941 NCI-2012-01712 NCI-2012-01712, S12-02028 Ph 1 active not recruiting Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma
NCT00644228 results posted NCI-2009-00798 NCI-2009-00798, SWOG-S0777 Ph 3 active not recruiting Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
NCT05250973 AQUARIUS CR109160 54767414AMY2009, 2021-002639-48 Ph 2 active not recruiting A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
NCT04133636 CARTITUDE-2 CR108581 68284528MMY2003, 2018-004124-10 Ph 2 active not recruiting A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma
NCT05572515 MajesTEC-9 CR109244 64007957MMY3006, 2022-000928-37 Ph 3 active not recruiting A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT01861314 NCI-2013-00999 NCI-2013-00999, OSU-11186 Ph 1 active not recruiting Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia
NCT03984097 TAK-079-1002 U1111-1230-4820 Ph 1 completed A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
NCT04433156 HNSZLYYNHL03 Ph 2 completed VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
NCT05736419 23-009 Ph 2 recruiting A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT)
NCT03652064 results posted CR108529 54767414MMY3019, 2018-001545-13 Ph 3 active not recruiting A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
NCT04975997 EXCALIBER-RRMM CC-220-MM-002 U1111-1260-2872, 2020-000431-49 Ph 3 active not recruiting Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
NCT04268498 ADVANCE 20201316 2019-001645-41, 19-339 Ph 2 active not recruiting A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

Showing 50 of 369 trials

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Key Completed Trials

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Trial Timeline

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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.

BORTEZOMIB FDA Label Details

View full patent landscape →
4 OB patents · 2 families · 19 international docs across 5 countries

BORTEZOMIB Patents & Exclusivity

Latest Patent: Sep 2042

Patents (4 active)

US11752164 Expires Sep 23, 2042
US11679119 Expires Sep 23, 2042
US12005069 Expires Sep 23, 2042
US8962572 Expires Nov 3, 2032
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2042
  • • 21 active patents

Trial Analysis

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Data Sources

FDA Approval: NDA205004 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.