Drug · Small Molecule

Bortezomib

CI-DRUG-00000113Explore in graph →NCIt C1851 CHEMBL325041 CIViC Approved

Regulatory

Approvals (51)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory5 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	—	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.	approved	Nov 14, 2019	ema
EU EMA	—	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.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 13 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	128	52	104	699	51	CA, EU, US	May 13, 2003	1999-07
Non-Hodgkin Lymphoma	Approved	Phase 4	100	36	93	457	8	US	May 13, 2003	Feb 8, 2001
Multiple Myeloma	Approved	Phase 4	87	30	87	353	4	US	May 13, 2003	Feb 8, 2001
Leukemia	Phase4	Phase 4	15	10	5	78	0	—

Curated evidence

Clinical evidence (3)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–3 of 3 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
GATA2 EXPRESSION1
Bortezomib + Fasudil

Clinical trials

Trials with this intervention (722)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 601–650 of 722 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00077467	Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia	completed	Phase 1	36	National Cancer Institute (NCI)NIH	1	Jun 5, 2013	clinicaltrials
NCT00030368	Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors	completed	Phase 1

Molecule

Record

Kind: Small Molecule
Mechanism: 26S proteasome inhibitor
Targets: 38 genes
UNII: 69G8BD63PP
Aliases: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, ACT BORTEZOMIB, Bortezomib, Bortezomib Accord, BORTEZOMIB FOR INJECTION SDZ, Bortezomib Fresenius Kabi, Bortezomib Hospira, Bortezomib hydrate, Bortezomib Mannitol Boronic Ester, Bortezomib Sun, Boruzu, BORUZU, LDP 341, LDP-341, LDP341, MLN 341, MLN341, NSC-681239, PMS-BORTEZOMIB, PS 341, PS-341, PS341, TARO-BORTEZOMIB, Velcade, VELCADE

Data updated 16 hours agoSource updated unknown

Identifiers

Codes (57)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XG01	BORTEZOMIB
ATC (WHO)	L01XX32