Midostaurin

Sold as Rydapt. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 14, 2026, FDA lists 5 applications for Midostaurin (sold as Rydapt), first approved Apr 28, 2017, with 1 new use approved and 0 published complete response letters.

First approved: Apr 28, 2017
Applications: 5
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $31.3M
First approved in the EU: Sep 18, 2017

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Rydapt	Part D	$31.3M	+14%	301

Orphan Designations (FDA)

2 designations, 2 approved for the designated use; see all orphan designations

Treatment of mastocytosisNovartis Pharmaceuticals Corporation · designated Apr 30, 2010 · approved Apr 28, 2017
Treatment of acute myeloid leukemiaNovartis Pharmaceuticals Corporation · designated Jul 7, 2009 · approved Apr 28, 2017

Approvals in the EU (EMA)

First approved in the EU 5 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Rydapt, new substanceNovartis Europharm Ltd · Sep 18, 2017

Clinical Trials

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


Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid LeukemiaLeukemia, Myeloid, Acute · University Hospital, Bordeaux	Phase 1 / Phase 2	Not yet recruiting	Jul 24, 2026
Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AMLAcute Myeloid Leukemia, Relapsed/Refractory Acute Myeloid Leukemia · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	—	Not yet recruiting	May 7, 2026
FLT3-ITD Targeted Therapy in Fit AML PatientsAML (Acute Myeloid Leukemia) · European Organisation for Research and Treatment of Cancer - EORTC	Phase 2 / Phase 3	Not yet recruiting	Feb 23, 2026
Revumenib in Combination With 7+3 + Midostaurin in AMLAcute Myeloid Leukemia, AML, Adult · Richard Stone, MD	Phase 1	Recruiting	Mar 15, 2024
Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia PatientsAcute Myeloid Leukemia, Adult · University Hospital Tuebingen	Phase 1	Recruiting	Feb 9, 2024
Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia (AML) · Acute Leukemia French Association	—	Recruiting	Mar 2, 2021
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)Acute Myeloid Leukemia · Technische Universität Dresden	Phase 1 / Phase 2	Recruiting	May 12, 2020
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS PatientsAML/MDS · Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 2	Active, not recruiting	Sep 20, 2019

Applications

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


Apr 28, 2017	RydaptNDA 207997 · Efficacy (new indication or use)	Novartis	6	Marketed
Apr 29, 2024	MidostaurinANDA 216076	Teva Pharms	0	Discontinued
May 10, 2024	MidostaurinANDA 216015	Lupin	0	Marketed
Jun 28, 2024	MidostaurinANDA 215921	Dr Reddys	0	Marketed
—	MidostaurinANDA 215834	Lotus Pharm Co Ltd	0	Discontinued

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