๐Ÿ‡ฎ๐Ÿ‡ชIreland
16ยฐC Partly Cloudy ยท Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Priya Life Science Compound trial record
Trackers Drugs Trial finder
Compound · clinical trials

Midostaurin clinical trials

Also listed in trial records as Rydapt, PKC412
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 5 trials in our Germany, Netherlands, Belgium, Switzerland, Ireland, France, Spain, Sweden, Austria, Norway, Australia, Italy, Poland, Czechia, Turkey, Japan, South Korea and Israel registers that name Midostaurin as an intervention. Synced 26 Sep 2026
5Current trials
1Recruiting now
4Lead sponsors
18Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Midostaurin is named as an intervention in 5 current clinical trials in our Germany, Netherlands, Belgium, Switzerland, Ireland, France, Spain, Sweden, Austria, Norway, Australia, Italy, Poland, Czechia, Turkey, Japan, South Korea and Israel registers. 1 is recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Stichting Hemato-Oncologie voor Volwassenen Nederland (2). The most-studied condition is Acute Myeloid Leukemia.

Trials by status

  • Recruiting120%
  • Active, closed480%

Trials by phase

  • Phase 2240%
  • Phase 3120%
  • Phase 1/2120%
  • Phase 1120%
01

Clinical trials of Midostaurin

5 trials
StudyPhaseStatusLead sponsorRegisters
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
NCT04385290 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia
Phase 1/2 Recruiting Technische Universitรคt Dresden Germany
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
NCT04027309 · Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
Phase 3 Active, closed Stichting Hemato-Oncologie voor Volwassenen Nederland Ireland, Germany, France, Spain, Netherlands, Belgium, Sweden, Switzerland, Austria, Norway, Australia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
NCT03591510 · ClinicalTrials.gov ↗ · FLT3-mutated Acute Myeloid Leukemia
Phase 2 Active, closed Novartis Pharmaceuticals Germany, Italy, Poland, Czechia, Turkey, Japan, South Korea
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
NCT04097470 · ClinicalTrials.gov ↗ · AML/MDS
Phase 2 Active, closed Stichting Hemato-Oncologie voor Volwassenen Nederland Germany, Netherlands, Belgium, Switzerland
RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS
NCT00819546 · ClinicalTrials.gov ↗ · Acute Myeloid Leukemia, Myelodysplastic Syndrome
Phase 1 Active, closed Richard Stone, MD Israel

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Midostaurin across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

1 single-substance product containing Midostaurin on the HPRA medicines list.

  • Rydapt 25 mg soft capsulesNovartis Europharm Limited · EU/1/17/1218/001
All 1 Irish product →

Supply shortages

No entry for Midostaurin in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Midostaurin

5 conditions
Acute Myeloid Leukemia3Myelodysplastic Syndrome With Excess Blasts-21AML/MDS1FLT3-mutated Acute Myeloid Leukemia1Myelodysplastic Syndrome1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Stichting Hemato-Oncologie voor Volwassenen Nederland2
Technische Universitรคt Dresden1
Novartis Pharmaceuticals1
Richard Stone, MD1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Germany41
Clinical trials in Netherlands20
Clinical trials in Belgium20
Clinical trials in Switzerland20
Clinical trials in Ireland10
Clinical trials in France10
Clinical trials in Spain10
Clinical trials in Sweden10
Clinical trials in Austria10
Clinical trials in Norway10
Clinical trials in Australia10
Clinical trials in Italy10
Clinical trials in Poland10
Clinical trials in Czechia10
Clinical trials in Turkey10
Clinical trials in Japan10
Clinical trials in South Korea10
Clinical trials in Israel10

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Midostaurin trials

How many clinical trials are testing Midostaurin?

5 current trials in our Germany, Netherlands, Belgium, Switzerland, Ireland, France, Spain, Sweden, Austria, Norway, Australia, Italy, Poland, Czechia, Turkey, Japan, South Korea and Israel registers name Midostaurin (also registered as PKC412) as a drug or biological intervention, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Midostaurin trials recruiting patients?

Yes. 1 of the 5 trials is recruiting: 1 with sites in Germany. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Midostaurin clinical trials?

Stichting Hemato-Oncologie voor Volwassenen Nederland (2), Technische Universitรคt Dresden (1), Novartis Pharmaceuticals (1) and Richard Stone, MD (1). The number in brackets is how many trials each organisation leads.

Are there Midostaurin clinical trials in Ireland?

Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.

Is Midostaurin licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Midostaurin, for example Rydapt 25 mg soft capsules (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Midostaurin shortage?

Not in the lists we track: Midostaurin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Midostaurin works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Midostaurin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Midostaurin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.