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Ninlaro (IXAZOMIB)
Ninlaro blocks the action of proteasomes, which are cellular complexes that break down and recycle proteins.
Ninlaro (IXAZOMIB) is a small molecule proteasome inhibitor developed by Millennium Pharms and currently owned by Takeda Pharms Usa. It targets the proteasome subunit beta type-5 and was FDA approved in 2015 for the treatment of multiple myeloma. Ninlaro is a patented medication with no generic manufacturers available. Key safety considerations include its long half-life of 97.0 hours. As a proteasome inhibitor, Ninlaro works by blocking the action of proteasomes, which are cellular complexes that break down and recycle proteins.
At a glance
| Generic name | IXAZOMIB |
|---|---|
| Sponsor | Takeda |
| Drug class | Proteasome Inhibitor |
| Target | Proteasome subunit beta type-5 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2015 |
| Annual revenue | 600 |
Mechanism of action
Ixazomib is reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta subunit of the 20S proteasome.Ixazomib induced apoptosis of multiple myeloma cell lines in vitro. Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone. The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines. In vivo, ixazomib demonstrated antitumor activity in mouse multiple myeloma tumor xenograft model.
Approved indications
- Multiple myeloma
Common side effects
- Diarrhea
- Constipation
- Thrombocytopenia
- Peripheral neuropathy
- Nausea
- Peripheral edema
- Back pain
- Vomiting
- Upper respiratory tract infection
- Rash
- Eye disorders
- Edema peripheral
Key clinical trials
- Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis (PHASE1)
- A Study of Ixazomib (NINLARO®) in Combination With Lenalidomide and Dexamethasone (IRD) for the Treatment of Participants With Multiple Myeloma (MM) (PHASE4)
- Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia (PHASE2)
- Ixazomib + Pomalidomide + Dexamethasone In MM (PHASE1,PHASE2)
- Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma (PHASE2)
- A Study of Ninlaro in Real World Clinical Practice in China
- Trial of Ixazomib for Kaposi Sarcoma (PHASE2)
- Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ninlaro CI brief — competitive landscape report
- Ninlaro updates RSS · CI watch RSS
- Takeda portfolio CI