Drug · Small Molecule

Ixazomib

CI-DRUG-00000314Explore in graph →NCIt C97940 CHEMBL2141296 CIViC Phase 3

Regulatory

Approvals (6)

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

openfdaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2022-04-28 (see label)	approved	Apr 28, 2022	openfda
US FDA	Multiple Myeloma	NINLARO ® is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials. ( 1 ) Limitations of Use : NINLARO is not recommended for use in the maintenance setting or in newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone outside of controlled clinical trials [see Warnings and Precautions (5.9) and Clinical Studies (14.2 , 14.3) ] .	approved	Nov 20, 2015	openfda

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 14 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	18	4	7	112	6	CA, EU, US	Nov 20, 2015	Mar 2, 2009
Non-Hodgkin Lymphoma	Approved	Phase 4	16	3	7	85	2	EU, US	Nov 20, 2015	2009-10
Multiple Myeloma	Approved	Phase 4	11	3	7	69	2	EU, US	Nov 20, 2015	2009-10
Leukemia	Phase2	Phase 2	3	1	0	11	0	—

Curated evidence

Clinical evidence (1)

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

civicCuratedShowing 1–1 of 1 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
KRAS Mutation1
Ixazomib	Malignant Colorectal Neoplasm

Clinical trials

Trials with this intervention (114)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 101–114 of 114 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
NCT02030405	Ixazomib (MLN9708) in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia	terminated	Phase 2	4	Steven E. CoutreOTHER	1	Apr 5, 2019	clinicaltrials
NCT03856112	Ixazomib and Dexamethasone With or Without Venetoclax in Treating Patients With Non-t(11;14) Relapsed or Refractory Multiple Myeloma	withdrawn	Phase 1 / Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: 26S proteasome inhibitor
Targets: 38 genes
UNII: 46CWK97Z3K
Aliases: {(1R)-1-[(2,5-dichlorobenzamido)acetamido]-3-methylbutyl}boronic Acid, Ixazomib, Ixazomib Citrate, MLN 2238, MLN-2238, MLN2238, MLN-9708 FREE BASE, NINLARO

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (8)

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

System	Code	Label
ATC (WHO)	L01XG03	IXAZOMIB
DIN (Health Canada)	02456796	NINLARO
DIN (Health Canada)	02456818