Overview
Midostaurin (as Rydapt) is a multitarget kinase inhibitor for the treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. It was initially characterized as a potential broad-spectrum antineoplastic agent, with activity toward diverse solid and hematopoietic tumors . It was approved on April 28, 2017 and has shown to increase the overall survival rate in patients with AML as an adjunct therapy along with chemotherapeutic agents.
Indication
Investigated for use/treatment in adult patients with high-risk acute myeloid leukemia (AML) who are FLT3 mutation-positive, agressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Associated Conditions
- Acute Myeloid Leukemia
- Aggressive Systemic Mastocytosis
- Mast Cell Leukemia (MCL)
- Systemic Mastocytosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/15 | Phase 1 | Recruiting | Richard Stone, MD | ||
2022/08/04 | N/A | Completed | |||
2022/02/02 | N/A | NO_LONGER_AVAILABLE | |||
2021/07/29 | Phase 1 | Withdrawn | Guenther Koehne | ||
2020/08/04 | Phase 1 | Terminated | |||
2019/11/22 | Phase 3 | Recruiting | |||
2019/09/20 | Phase 2 | Active, not recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | ||
2019/09/03 | Phase 1 | Completed | |||
2019/07/19 | Phase 3 | Active, not recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | ||
2019/05/16 | Phase 2 | Terminated | University of Jena |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0698 | ORAL | 25 mg in 1 1 | 6/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/18/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| RYDAPT SOFT CAPSULE 25MG | SIN15518P | CAPSULE, LIQUID FILLED | 25mg | 7/30/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Midostaurin-RZ Midostaurin 25 mg soft capsule blister pack | 418125 | Medicine | A | 2/24/2025 | |
| RYDAPT midostaurin 25 mg soft capsule blister pack | 287013 | Medicine | A | 5/17/2018 | |
| Midostaurin Dr.Reddy's Midostaurin 25 mg soft capsule blister pack | 418124 | Medicine | A | 2/24/2025 |
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