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Drug

Bortezomib

Approved · EMA
Emerging researchLate-stage developmentRising momentum

Also known as BTZ, Boruzu, Velcade.

RxNorm358258ChEMBLCHEMBL325041UNII69G8BD63PP
5
Research papers
40
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib and Abatacept for the Prevention of Graft-versus-Host-Disease (GvHD) Following Allogenic Hematopoietic Stem Cell Transplantation (HSCT)

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

64407564MMY3009: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Pomalidomide (Tal-P), Talquetamab in Combination With Teclistamab (Tal-Tec), and Investigator's Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pom

Clinical trial2026-07-30Status changed to Active, not recruiting · ClinicalTrials.gov

Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity

Clinical trial2026-07-08Results expected Q4 2026 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Clinical trial2026-07-06Results expected Q3 2030 · ClinicalTrials.gov

Market withdrawal: Bortezomib Hospira (EMA)

Regulatory2025-08-07EMA

Approval: Bortezomib Fresenius Kabi (EMA)

Regulatory2019-11-14EMA

Approval: Bortezomib Sun (EMA)

Regulatory2016-07-22EMA

Approval: Bortezomib Accord (EMA)

Regulatory2015-07-20EMA

Proteasome inhibition in myelodysplastic syndromes and acute myelogenous leukemia cell lines.

Research2011-08-01Cancer investigation

Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study.

Research2011-02-21The Lancet. Oncology

Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma.

Research2010-12-14Cancer

Phase II trial of weekly bortezomib in combination with rituximab in relapsed or relapsed and refractory Waldenstrom macroglobulinemia.

Research2010-02-08Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Bortezomib
Aliases & brands
BTZBoruzuVelcade
RxNorm CUI
358258
ChEMBL ID
CHEMBL325041
UNII
69G8BD63PP
Regulatory jurisdictions
ema

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-04-26
Latest approval
2019-11-14
Authorities
EMA
Total events
5
emaEuropean Medicines Agency· 5 events
2025-08-07Market withdrawalMarket
Market withdrawal: Bortezomib Hospira (EMA)
Indication: Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive… Show full indication

Bortezomib Hospira as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Hospira in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Hospira in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Evidence ↗
2019-11-14Approval
Approval: Bortezomib Fresenius Kabi (EMA)
Indication: Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple… Show full indication

Bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Evidence ↗
2016-07-22Approval
Approval: Bortezomib Sun (EMA)
Indication: Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple… Show full indication

Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
199
registered trials across all phases
LATEST COMPLETION 2026
40
Active studies
19
Recruiting
35
Late-stage (III+)
106
Completed
53
Discontinued
PHASE DISTRIBUTIONn = 199
Early Phase 11Phase 131Phase 1 / 226Phase 2106Phase 329Phase 43Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

The Efficacy and Safety of Bortezomib as First-line Treatment for Acquired Thrombotic Thrombocytopenic Purpura

Unknown statusPH IVPeking Union Medical College Hospitaln=302025

An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma

Unknown statusPH IVShanghai General Hospital, Shanghai Jiao Tong University School of Medicinen=802018

Pharmacokinetic Study of Bortezomib (VELCADE) Administered Intravenously in Taiwanese Patients With Multiple Myeloma - A Post Approval Commitment Study

CompletedPH IVJohnson & Johnson Taiwan Ltdn=182015

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

Active, not recruitingPH IIIStichting European Myeloma Networkn=7592040

A Phase 3, Open-label, Controlled, Randomized Study of Newly Diagnosed Multiple Myeloma Treatment, Designed to Evaluate the Efficacy and Safety of the Elranatamab-lenalidomide Combination as a Replacement for Chemotherapy Followed by Autologous Stem Cell Transplant in the Consolidation Phase, and to Compare Elranatamab With Standard of Care in the Maintenance Phase

RecruitingPH IIIIntergroupe Francophone du Myelomen=8242036

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

CompletedPH IIIJanssen Research & Development, LLCn=3952026

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

CompletedPH IIICelgenen=3862026

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib (NSC# 681239, NSC# 724772) for Patients With High Allelic Ratio FLT3/ITD

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=1,6452026

Response Adapted Therapy With Bortezomib/Dexamethasone Followed by Addition of Lenalidomide in Non Responders as Initial Treatment for Patients With Multiple Myeloma

CompletedPH IIMemorial Sloan Kettering Cancer Centern=302024

A Phase II Study of High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

CompletedPH IINYU Langone Healthn=232024

An Open-Label Phase 1 Study of Metformin and Nelfinavir in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma

CompletedPH IMayo Clinicn=92023

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20092011
Most influential

Single-agent bortezomib in previously untreated multiple myeloma: efficacy, characterization of peripheral neuropathy, and molecular correlations with response and neuropathy.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 214 cites

Phase II trial of weekly bortezomib in combination with rituximab in relapsed or relapsed and refractory Waldenstrom macroglobulinemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 112 cites

Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study.

The Lancet. Oncology · 2011 · 66 cites

Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma.

Cancer · 2011 · 31 cites

Proteasome inhibition in myelodysplastic syndromes and acute myelogenous leukemia cell lines.

Cancer investigation · 2011 · 12 cites
Recent papers

Weekly bortezomib in combination with temsirolimus in relapsed or relapsed and refractory multiple myeloma: a multicentre, phase 1/2, open-label, dose-escalation study.

The Lancet. Oncology · 2011 · 66 cites

Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma.

Cancer · 2011 · 31 cites

Proteasome inhibition in myelodysplastic syndromes and acute myelogenous leukemia cell lines.

Cancer investigation · 2011 · 12 cites

Phase II trial of weekly bortezomib in combination with rituximab in relapsed or relapsed and refractory Waldenstrom macroglobulinemia.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 112 cites

Single-agent bortezomib in previously untreated multiple myeloma: efficacy, characterization of peripheral neuropathy, and molecular correlations with response and neuropathy.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 214 cites
Major research themes2
Proteasome Inhibitors1Stem Cell Transplantation1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • Cancer1
  • Cancer investigation1
  • The Lancet. Oncology1
Leading researchers
  • Anderson KC3
  • Richardson PG3
  • Weller E3
  • Chuma S2
  • Ghobrial IM2
  • Harris B2
  • Kunsman J2
  • Leduc R2
Leading institutions
free-text, unnormalised
  • Dana-Farber Cancer Institute3
  • Ohio State University1
  • University of Rochester Medical Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.