TheraRadar
Data updated: May 26, 2026

NINLARO (ixazomib citrate)

Trial Activity: Stable 27 active trials
Oncology Approved 2015-11-20

Ninlaro helps patients with multiple myeloma who have already received at least one previous therapy. It is used as part of a combination regimen alongside lenalidomide and dexamethasone to manage the cancer after earlier treatments. This medication is specifically for those who have relapsed and is not recommended for newly diagnosed patients or for use as a maintenance therapy.

Source: FDA Label • Takeda
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How NINLARO Works

This drug works by reversibly binding to and inhibiting the proteasome, specifically targeting the chymotrypsin-like activity of the beta 5 subunit. By blocking this cellular process, the medication triggers programmed cell death in myeloma cells, including those that have become resistant to other therapies.

Source: FDA Label

Development Insights

Millennium Pharmaceuticals, Inc. conducting 19 trials (17%)
130 indications explored (Broad Platform)
→ multiple myeloma (36 trials)
→ recurrent plasma cell myeloma (12 trials)
→ refractory plasma cell myeloma (8 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
10
Years on Market

Details

Status
Prescription
First Approved
2015-11-20
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

Takeda
Active Ingredient: IXAZOMIB CITRATE

NINLARO Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2015 to 2024 · 1 indication expansions
Jul 2024 SUPPL
Label · Labeling
FDA Letter Label
Mar 2024 SUPPL
Label · Labeling
FDA Letter Label
Apr 2022 SUPPL
Efficacy
Label

What NINLARO Treats

1 indications

NINLARO is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Myeloma
Source: FDA Label

NINLARO Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

OZILTUS
AMNEAL PHARMS
2025 4 indic.
BLENREP
GSK
2025 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in NINLARO's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NINLARO treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

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Clinical Trial Registry

109 trials
Trial Sponsor ID Phase Status Title
NCT04847453 NCI-2021-03038 NCI-2021-03038, PHI-124 Ph 1 active not recruiting Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
NCT03547700 results posted BTCRC-HEM15-028 Ph 1, Ph 2 terminated Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
NCT03506373 results posted MC178B 18-000580 Ph 2 terminated Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia
NCT03173092 C16038 U1111-1192-7696 Ph 4 terminated A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM)
NCT02343042 STOMP KCP-330-017 Ph 1, Ph 2 active not recruiting Selinexor and Backbone Treatments of Multiple Myeloma Patients
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
NCT04094961 19-291 Ph 1, Ph 2 active not recruiting Ixazomib + Pomalidomide + Dexamethasone In MM
NCT02339922 results posted 9571 NCI-2016-00401, 9224 Ph 2 active not recruiting Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma
NCT03283917 2017-0243 NCI-2018-01044, 2017-0243 Ph 1 active not recruiting Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis
NCT04305691 AMC-107 NCI-2020-01138, AMC-107 Ph 2 recruiting Trial of Ixazomib for Kaposi Sarcoma
NCT02389517 results posted IRB14-0899 NCI-2015-00138, X16047 Ph 2 completed Lenalidomide With or Without Ixazomib Citrate and Dexamethasone in Treating Patients With Residual Multiple Myeloma After Donor Stem Cell Transplant
NCT03587662 2018-0065 NCI-2018-01292, 2018-0065 Ph 2 active not recruiting Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
NCT02619682 results posted 9266 NCI-2015-01861, X16064 Ph 2 completed Alternating Ixazomib Citrate and Lenalidomide as Maintenance Therapy After Stem Cell Transplant in Treating Patients With Multiple Myeloma
NCT05722405 2022-0215 Ph 4 recruiting Ixazomib Plus Low-dose Lenalidomide Versus Ixazomib Alone for Maintenance Treatment of High Risk Multiple Myeloma
NCT04009109 AFT-41 Ph 2 active not recruiting Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM
NCT04068597 CCS1477-02 Ph 1, Ph 2 recruiting Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
NCT02461888 MUKEight HM13/10993 Ph 2 completed Phase II Randomised Trial of Cyclophosphamide & Dexamethasone in Combination With Ixazomib in Relapsed or Refractory Multiple Myeloma.
NCT03618537 18-069 Ph 2 active not recruiting Ixazomib Maintenance Study in Patients With AL Amyloidosis
NCT02253316 results posted 201411060 Ph 2 active not recruiting Phase II Study of IRD (Ixazomib, Lenalidomide, Dexamethasone) Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma
NCT02420847 2014-0661 NCI-2015-00682, 2014-0661 Ph 1, Ph 2 active not recruiting Ixazomib Citrate With Gemcitabine Hydrochloride and Doxorubicin Hydrochloride in Treating Patients With Urothelial Cancer That is Metastatic or Cannot Be Removed by Surgery
NCT03590652 180638 Ph 2 terminated Daratumumab, Ixazomib, Pomalidomide, and Dexamethasone as Salvage Therapy in Relapsed/Refractory Multiple Myeloma
NCT02412228 results posted 299 Ph 2 completed Ixazomib, Cyclophosphamide and Dexamethasone for Multiple Myeloma
NCT01415882 results posted MC1181 NCI-2011-02303, 11-001516 Ph 2 completed Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib
NCT01659658 results posted C16011 2011-005468-10, U1111-1164-7621 Ph 3 terminated Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
NCT02916771 results posted 16-313 Ph 2 completed Trial of Combination of Ixazomib and Lenalidomide and Dexamethasone in Smoldering Multiple Myeloma
NCT01864018 results posted MC1382 NCI-2013-01042, X16009 Ph 1, Ph 2 completed Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis
NCT04052880 GCO 19-0944 Ph 2 active not recruiting Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM
NCT05451771 AAAT8639 Ph 1, Ph 2 recruiting Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
NCT02765854 results posted IRB00077815 NCI-2016-00043, MMRC060 Ph 2 completed Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement
NCT03770260 results posted NCI-2018-03121 NCI-2018-03121, 10249 Ph 1 completed Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment
NCT03817320 results posted T2017-002 Ph 1, Ph 2 active not recruiting PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
NCT03012880 results posted MC1686 NCI-2017-00007, MC1686 Ph 2 completed Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT03941860 results posted NCI-2019-02790 NCI-2019-02790, EAA171 Ph 3 completed Testing the Addition of Ixazomib/Placebo to Lenalidomide in Patients With Evidence of Residual Multiple Myeloma, OPTIMUM Trial
NCT04047797 results posted 2018-1090 NCI-2019-04857, 2018-1090 Ph 2 terminated Ixazomib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT04837131 results posted 20-004201 Ph 2 terminated A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients
NCT04998786 I2D IFM2021_03 RC21_0169 2021-001587-13 Ph 2 active not recruiting A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."
NCT03376672 NMSG#23/15 Ph 2 active not recruiting Ixazomib Plus Lenalidomide Plus Dexamethasone for Newly Diagnosed Myeloma Patients
NCT03748953 results posted C16021 CCS 2014-001394-13 Ph 3 completed Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT)
NCT02924272 results posted C16027 U1111-1184-2041, 2016-001681-28 Ph 2 completed Ixazomib Rollover Study
NCT03457142 results posted I 47217 NCI-2017-02430, I 47217 Ph 2 terminated Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy
NCT01718743 results posted 2012-0277 NCI-2012-02873, 2012-0277 Ph 2 completed Ixazomib Citrate and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT02181413 results posted C16019 U1111-1155-8695, 2013-002076-41 Ph 3 completed A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
NCT06050512 HCC 21-200 Ph 1, Ph 2 withdrawn Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
NCT03399539 MC168C NCI-2017-02456, MC168C Ph 1 completed Venetoclax, Ixazomib Citrate, and Dexamethasone in Treating Patients with Relapsed Multiple Myeloma
NCT02542657 728937 UCDCC#253, X16043 Ph 1, Ph 2 active not recruiting Ixazomib with Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients with Multiple Myeloma
NCT02633059 results posted MC1582 NCI-2015-02155, NP29909 Ph 1, Ph 2 completed Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
NCT03225417 X16082 Ph 1, Ph 2 active not recruiting Ixazomib in the Prophylaxis of Chronic Graft-versus-host Disease.
NCT04217967 ZS-2129 Ph 4 completed Ixazomib, Lenalidomide, and Combination for Maintenance in NDMM Patients
NCT03439293 results posted C16047 U1111-1202-6022, 2017-003977-32 Ph 2 completed A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT03942224 DeRIVE IRB00102336 NCI-2018-03615, Winship4547-18 Ph 2 active not recruiting Daratumumab, Ixazomib, & Dexamethasone or Daratumumab, Bortezomib, & Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Showing 50 of 109 trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

NINLARO FDA Label Details

Indications & Usage

FDA Label (PDF)

NINLARO is indicated for the treatment of Multiple Myeloma.

View full patent landscape →
7 OB patents · 2 families · 186 international docs across 39 countries

NINLARO Patents & Exclusivity

Latest Patent: Nov 2029

Patents (7 active)

US7442830 Expires Nov 20, 2029
US9175017 Expires Jun 16, 2029
US8859504 Expires Jun 16, 2029
US8871745 Expires Aug 6, 2027
US8003819 Expires Aug 6, 2027
US8530694 Expires Aug 6, 2027
US7687662 Expires Aug 6, 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for NINLARO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 63 active patents

Trial Analysis

  • • 113 total trials
  • • Stage: Stable

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA208462 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment