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Ninlaro Approval History

FDA Approved: Yes (First approved November 20, 2015)
Brand name: Ninlaro
Generic name: ixazomib
Dosage form: Capsules
Company: Takeda Pharmaceutical Company Limited
Treatment for: Multiple Myeloma

Ninlaro (ixazomib) is an oral proteasome inhibitor indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Development History and FDA Approval Process for Ninlaro

DateArticle
Nov 20, 2015Approval FDA Approves Ninlaro (ixazomib) for Multiple Myeloma
Sep  9, 2015U.S. FDA Grants Priority Review to Takeda's Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma
Jul 15, 2015Takeda Submits NDA for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma
May 12, 2015Takeda Announces First Patient Enrolled in Global Phase 3 Study of Ixazomib as Maintenance Therapy for Newly Diagnosed Multiple Myeloma
Feb 10, 2015Takeda Announces That the First Interim Analysis of the Phase 3 Study of Oral Ixazomib in Patients with Multiple Myeloma Met Primary Endpoint
Dec  7, 2014Takeda Presents Phase 2 Data on Maintenance with Single-Agent Investigational Ixazomib in Patients with Newly Diagnosed Multiple Myeloma
Dec  1, 2014Takeda's Investigational, Oral Proteasome Inhibitor Ixazomib Granted Breakthrough Therapy Designation by FDA

Further information

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