ixazomib

Trade name: ninlaro

Small moleculeapprovedOrphan Drug ^FDA

Approved

Nov 20, 2015

Ixazomib (MLN2238) is an active metabolite of orally bioavailable proteasome inhibitor ixazomib citrate (MLN9708), which hydrolyzes upon administration. Ixazomib citrate was approved under the name Ninlaro for the treatment of multiple myeloma in patients who have received at least one prior therapy. In vitro studies has shown that ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome. — NCATS

Clinical trial activity

151 trials · 119 clinical orgs · 2 marketing orgs

Phase 1

Phase 2

109

Phase 3

Phase 4

Earliest trial started Mar 1, 2009 (NCT00830869)

Timeline

2000s

Jan 1, 2009
Millennium Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

2010s

Feb 18, 2011
Orphan Drug Designation
Jan 1, 2012
Earliest Phase 2 Sponsor(trial)
Jan 1, 2012
Millennium Pharmaceuticals — Earliest Phase 3 Sponsor(trial)
Nov 20, 2015
Takeda — Earliest FDA Approval
Nov 20, 2015
Takeda — NDA Organization
Nov 20, 2015
Takeda — Marketing Organization
Nov 20, 2015
Millennium Pharmaceuticals — NDA Secondary Org

Indications

Approved for

Multiple Myeloma

Studied for

Mechanism of action

26S proteosomeINHIBITOR
26S proteosome inhibitor
Prodrug of ixazomib
Beta-5 subunit

Approval history

approvedPriority reviewNov 20, 2015

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)C[C@H](NC(=O)CNC(=O)C1=CC(Cl)=CC=C1Cl)B(O)O

Mol. weight: 361.029 g/mol
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Prescription Only

Oral

Parenteral

Topical

Sources

Also known as

ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib
ixazomib citrate
ixazomib citrate
ixazomib citrate
ixazomib citrate
ixazomib citrate
mln2238
mln2238
mln2238
mln9708
mln9708
mln9708
mln9708
mln 9708
mln 9708
mln 9708
mln-9708
mln-9708
mln-9708
ninlaro
ninlaro
ninlaro
ninlaro
ninlaro
ninlaro

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06744894	Phase 2	Jan 1, 2025	Government of China
NCT06050512	Phase 1/Phase 2 (Phase 2)	Oct 2, 2023	Bristol-Myers Squibb, University of Pittsburgh
NCT05675319	Phase 3	Mar 3, 2023	Gemeinsamer Bundesausschuss, Staburo GmbH, University of Hamburg
NCT05451771	Phase 1/Phase 2 (Phase 2)	Oct 26, 2022	Columbia University, Genentech
NCT05477797	N/A	Aug 1, 2022	Jiao Tong University
NCT05722405	Phase 4	Jul 1, 2022	Dongyang People's Hospital, Huizhou People's Central Hospital, Lishui Country People's Hospital, Nanchang University, Shaoxing People's Hospital, Shaoxing Second Hospital, Zhejiang University
NCT05183139	Phase 4	Jun 30, 2022	Takeda
NCT04998786	Phase 2	Dec 1, 2021	University of Nantes
NCT04847453	Phase 1	Sep 14, 2021	City of Hope National Medical Center, National Cancer Institute (NCI)
NCT04989140	Phase 4	Jul 26, 2021	Anhui Medical University, Capital Medical University, China Medical University, Chinese Academy of Medical Sciences, Dalian Medical University, Harbin Medical University, Peking University, Shanxi Medical University, Tianjin Medical University, Zhengzhou University
NCT04837131	Phase 2	Apr 28, 2021	Mayo Clinic
NCT04790474	Phase 2	Mar 25, 2021	Ben Gurion University, Hebrew University, Shiba Tel Hashomer Medical Center, Technion University, Tel Aviv University
NCT04305691	Phase 2	Nov 21, 2020	AIDS Malignancy Consortium, National Cancer Institute (NCI)
NCT04405167	Phase 1	Jun 1, 2020	Active Biotech AB, University of Pennsylvania
NCT04463953	Phase 2	May 20, 2020	Chinese Academy of Medical Sciences
NCT03942224	Phase 2	May 1, 2020	Emory University, Janssen Pharmaceutica NV, Takeda
NCT04217967	Phase 4	Jan 3, 2020	Capital Medical University, Chinese Academy of Medical Sciences, Jilin Provincial Tumor Hospital, Peking University, Shanxi Medical University
NCT04047797	Phase 2	Nov 30, 2019	National Cancer Institute (NCI), University of Texas at Houston
NCT04119336	Phase 2	Oct 31, 2019	Bristol-Myers Squibb, Harvard University, Takeda
NCT04079738	Phase 1/Phase 2 (Phase 2)	Oct 31, 2019	Big Ten Cancer Research Consortium, Indiana University, Takeda

Showing 20 of 151 trials

Page 1 / 8

Organizations

Research & Development (119)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Millennium Pharmaceuticals	For profit	45	26	4	2009
Takeda	For profit	37	7	4	2012
National Cancer Institute (NCI)	Government	30	7	3	2012
Mayo Clinic	Academic/Hospital	12	12	1	2012
Celgene	For profit	11	1	2	2014
University of Texas at Houston	Academic/Hospital	9	9	2	2012
Harvard University	Academic/Hospital	7	6	2	2014
Janssen Pharmaceutica NV	For profit	7	0	2	2018
Emory University	Academic/Hospital	6	4	2	2016
Chinese Academy of Medical Sciences	Academic/Hospital	4	4	3	2018
Medical College of Wisconsin	Academic/Hospital	4	4	2	2013
Bristol-Myers Squibb	For profit	3	0	1	2018
Case Western Reserve University	Academic/Hospital	3	3	2	2014
Cornell University	Academic/Hospital	3	3	2	2016
Icahn School of Medicine at Mount Sinai	Academic/Hospital	3	3	1	2017
University of Leeds	Academic/Hospital	3	3	2	2015
University of Nantes	Academic/Hospital	3	2	1	2014
University of Washington	Academic/Hospital	3	3	1	2015
Arbeitsgemeinschaft medikamentoese Tumortherapie	Academic/Hospital	2	2	1	2015
Big Ten Cancer Research Consortium	Academic/Hospital	2	1	1	2018

119 organizations

Page 1 / 6

Marketing (3)

Organization	Org type	Relationship	Date
Millennium Pharmaceuticals	For profit	NDA2	Nov 20, 2015
Takeda	For profit	NDA	Nov 20, 2015
Takeda	For profit	MKTG	Nov 20, 2015