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midostaurin

Generic: MIDOSTAURIN·Brand: MIDOSTAURIN, RYDAPT, Rydapt

midostaurin: sourced relationships with 1 company · 2 clinical trials tracked · 1 FDA decision.

midostaurin evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect midostaurin to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could midostaurin → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

FLT3-mutated Acute Myeloid LeukemiaAML, AdultAcute Myeloid LeukemiaLeukemia

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (3)
CompanyDated record stage
Novartis AG (NVS)
Reported 2017-04-28 · Current development: unknownSource
Approved
Novartis AG (NVS)
Reported 2017-04-28 · Current development: unknownSource
FLT3-mutated Acute Myeloid Leukemia
Phase 2
Novartis AG (NVS)
Reported 2017-04-28 · Current development: unknownSource
Approved
Clinical Trial Registry Records (2)

A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML

NCT06313437Registry updated 2026-03-25·Phase 1
Recruiting

Primary endpoint: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

Interventionalopen22 targetStarted 2024-12Completion 2028-032 sites · United StatesRichard Stone, MD

A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML

NCT03591510Registry updated 2026-07-09·Phase 2
Active, not recruiting

Primary endpoint: Part 1 of the study: Occurence of dose limiting toxicities (DLT)

Interventionalopen22 enrolledStarted 2019-03Completion 2029-0515 sites · Czechia, Germany, Italy, Japan…Novartis Pharmaceuticals
FDA Decisions1 records
Approval(NVS)FDA ↗
NDA207997Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Which companies have sourced relationships with midostaurin?

midostaurin has dated SEC/FDA relationship records for Novartis AG.

How many clinical trials involve midostaurin?

BioSniper tracks 2 clinical trials involving midostaurin.

What is midostaurin's latest FDA decision?

The most recent tracked FDA decision for midostaurin is Approval, dated April 28, 2017.