NDAORALCAPSULEPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
50
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NINLARO (ixazomib) is an oral proteasome inhibitor small-molecule therapeutic approved by the FDA in November 2015 for use in multiple myeloma. It is the first and only oral proteasome inhibitor in its class, administered as a capsule once weekly. NINLARO works by inhibiting the 20S proteasome, leading to accumulation of proteins and inducing apoptosis in myeloma cells. It is typically used in combination with lenalidomide and dexamethasone, positioning it as a backbone therapy in standard multiple myeloma treatment regimens.
$0.3BPart D
3.5 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (50)
Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma
Started Oct 2023
0Relapsed and Refractory Multiple Myeloma
A Survey on NINLARO Risk Management Plan (RMP) Material Utilization Among Pharmacists in Japan
Started Jun 2023
330 enrolled
Multiple Myeloma
A Multicenter In-class Transition Study of Ixazomib Combined With Pomalidomide and Dexamethasone or With Lenalidomide and Dexamethasone in Adults With Relapsed/Refractory Multiple Myeloma
Started Jun 2022
0Multiple Myeloma
A Study of NINLARO® in Chinese Adults With Multiple Myeloma
Started Oct 2021
72 enrolled
Multiple Myeloma
Study of Pomalidomide, Oral Dexamethasone and Ixazomib in Patients With Relapsed MM Who Have Received Lenalidomide
Started Jul 2021
60 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.