TheraRadar
Data updated: May 26, 2026

MIDOSTAURIN

Oncology Approved 2024-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-04-29
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Dr. Reddy's Teva Lupin LOTUS PHARM CO LTD
Active Ingredient: MIDOSTAURIN

MIDOSTAURIN Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2024
Jun 2024 ORIGINAL
Update
May 2024 ORIGINAL
Update
Apr 2024 ORIGINAL
Update
FDA Letter

What MIDOSTAURIN Treats

3 FDA approvals

Originally approved for its first indication in 2024 . Covers 3 distinct patient populations.

  • Other (3)
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Clinical Trial Registry

29 trials
Trial Sponsor ID Phase Status Title
NCT03591510 CPKC412A2218 2017-004830-28 Ph 2 active not recruiting A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
NCT03258931 ARO-021 Ph 3 completed Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
NCT06313437 24-021 Ph 1 recruiting Revumenib in Combination With 7+3 + Midostaurin in AML
NCT02115295 2012-0648 NCI-2014-01103, 2012-0648 Ph 2 recruiting Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
NCT03900949 OSU-21190 NCI-2019-01726 Ph 1 completed Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia
NCT03836209 results posted PrE0905 Ph 2 active not recruiting Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
NCT03280030 results posted CPKC412A2220 Ph 2 completed A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
NCT03686345 AML FLT3 REL-AML 001/2017 2017-002094-18 Ph 2 terminated Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia
NCT03092674 results posted NCI-2017-00436 NCI-2017-00436, S1612 Ph 2, Ph 3 completed Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
NCT04027309 HOVON 156 AML HO156 2018-000624-33, AMLSG 28-18 Ph 3 active not recruiting A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
NCT04982354 2019-KOE-003 Ph 1, Ph 2 withdrawn Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
NCT04097470 HO155 HOVON 155 AML 2018-000047-31, 2018-674 Ph 2 active not recruiting Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
NCT03379727 results posted CPKC412A2408 2016-004440-12 Ph 3 completed Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.
NCT04075747 V-FAST JZP025-101 Ph 1 completed A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
NCT03512197 results posted CPKC412E2301 2017-003540-21 Ph 3 completed A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)
NCT04496999 HDMM HDMM Ph 1 terminated HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
NCT01093573 results posted CASE1908 NCI-2009-01285 Ph 1, Ph 2 completed Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia
NCT03951961 MAURITIUS 2019-000136-26 Ph 2 terminated Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation
NCT01429337 CPKC412A2116 2010-020694-16 Ph 1 completed PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
NCT01883362 RADIUS results posted CPKC412AUS23 Ph 2 completed Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
NCT01477606 AMLSG 16-10 2011-003168-63 Ph 2 completed Protocol in Acute Myeloid Leukemia With FLT3-ITD
NCT03760445 CHDM201A2101 2018-003107-19 Ph 1, Ph 2 withdrawn HDM201 Added to CT in R/R or Newly Diagnosed AML
NCT02634827 results posted MC1483 NCI-2015-02107, MC1483 Ph 2 terminated Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
NCT01282502 10-457 Ph 1 completed Midostaurin (PKC412) for Locally Advanced Rectal Cancer
NCT03207334 UF-HEM-004 CPKC412AUS61T, IRB201701934 Ph 2 withdrawn iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)
NCT01846624 results posted IRB-25737 HEMAML0022 Ph 2 terminated Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT01174888 OSU-09111 NCI-2010-01335 Ph 1 completed Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia
NCT00866281 results posted CPKC412A2114 2008-006931-11 Ph 1, Ph 2 terminated A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
NCT01161550 CLAG ATRA AML 10-1181 / 201108160 Ph 1 completed Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MIDOSTAURIN FDA Label Details

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Data Sources

FDA Approval: ANDA215921 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.