Lusutrombopag

Treats thrombocytopenia. Sold as Mulpleta. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Lusutrombopag (sold as Mulpleta), first approved Jul 31, 2018, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 31, 2018
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $247K
First approved in the EU: Feb 18, 2019
First approved in Japan: Sep 28, 2015

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Mulpleta	Part D	$247K	+21%	20

Approvals in the EU (EMA)

First approved in the EU 7 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Mulpleo (previously Lusutrombopag Shionogi), new substanceShionogi B.V. · Feb 18, 2019 · withdrawn

Approvals in Japan (PMDA)

First approved in Japan 34 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Mulpleta, new ingredientA drug with a new active ingredient indicated for the improvement of thrombocytopenia in patients with chronic liver disease for whom an elective invasive… · Shionogi & Co., Ltd. · Sep 28, 2015 · Review report

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell TransplantationPatients With Hematologic Disorders After Allogeneic Hematopoietic Stem Cell Transplantation, Hematologic Disorders · The General Hospital of Western Theater Command	Not applicable	Recruiting	Mar 19, 2026
Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive SurgeryThrombocytopenia · Anhui Provincial Hospital	Phase 2	Recruiting	Nov 5, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jul 31, 2018	MulpletaNDA 210923 · New molecular entity	Vancocin Italia	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA