Overview
Ixazomib a second generation proteasome inhibitor (PI) and the first oral PI approved by the FDA in November 2015 for multiple myeloma treatment in combination with 2 other therapies (lenalidomide and dexamethasone) for patients who have received at least 1 prior therapy. It was found to have similar efficacy to bortezomib (the first PI approved for multiple myeloma therapy) in the control of myeloma growth and prevention of bone loss. Ixazomib citrate is marketed by Takeda Pharmaceuticals under the brand name Ninlaro, which is a prodrug that becomes quickly converted to its active metabolite, ixazomib, after administration.
Indication
Ixazomib is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Associated Conditions
- Multiple Myeloma (MM)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/09/22 | Phase 1 | Withdrawn | Kathleen Dorritie | ||
2023/02/10 | Phase 4 | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2022/07/28 | Not Applicable | Recruiting | |||
2022/07/11 | Phase 1 | Recruiting | Rajshekhar Chakraborty, MD | ||
2022/01/10 | Phase 4 | Withdrawn | |||
2021/08/10 | Phase 2 | Active, not recruiting | |||
2021/04/19 | Phase 1 | Recruiting | |||
2021/04/08 | Phase 2 | Terminated | Michael M. Pham | ||
2020/03/12 | Phase 2 | Recruiting | AIDS Malignancy Consortium | ||
2020/02/17 | Phase 1 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/21/2016 | ||
Authorised | 11/21/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NINLARO CAPSULE 2.3mg | SIN15162P | CAPSULE | 2.3mg | 1/20/2017 | |
| NINLARO CAPSULE 4mg | SIN15164P | CAPSULE | 4mg | 1/20/2017 | |
| NINLARO CAPSULE 3mg | SIN15163P | CAPSULE | 3mg | 1/20/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NINLARO CAPSULES 4MG | N/A | N/A | N/A | 1/29/2018 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| NINLARO ixazomib (as citrate) 3mg capsule blister pack | 260935 | Medicine | A | 11/15/2016 | |
| NINLARO ixazomib (as citrate) 2.3mg capsule blister pack | 260936 | Medicine | A | 11/15/2016 | |
| NINLARO ixazomib (as citrate) 4mg capsule blister pack | 260934 | Medicine | A | 11/15/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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