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Ninlaro
Ninlaro works by blocking the proteasome, a cellular complex that breaks down proteins, leading to cell death in cancer cells.
Ninlaro is a small molecule proteasome inhibitor developed by Millennium Pharmaceuticals, targeting proteasome subunit beta type-5. It is FDA-approved for the treatment of multiple myeloma. Ninlaro works by inhibiting the proteasome, a complex that breaks down proteins in cells, thereby inducing cell death in cancer cells. The drug has a long half-life of 97.0 hours and is patented by its owner, Millennium Pharmaceuticals. Key safety considerations include its potential to cause neutropenia, thrombocytopenia, and peripheral neuropathy.
At a glance
| Generic name | Ninlaro |
|---|---|
| Also known as | Ixazomib |
| Sponsor | Millennium Pharms |
| Drug class | Proteasome Inhibitor |
| Target | Proteasome subunit beta type-5 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | discontinued |
| 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
- Peripheral neuropathy
- Constipation
- Peripheral edema
- Back pain
- Nausea
- Vomiting
- Thrombocytopenia
- Upper respiratory tract infection
- Rash
- Edema peripheral
- Blurred vision
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
- Millennium Pharms portfolio CI