Drug Profile

Midostaurin - Novartis Oncology

Alternative Names: 4-N-benzoyl staurosporine; Benzoylstaurosporine; CGP-41251; N-benzoyl-staurosporine; PKC-412; PKC-412A; Rydapt

Latest Information Update: 12 Jan 2026

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At a glance

Originator Novartis
Developer Massachusetts General Hospital; Mayo Clinic; National Cancer Institute (USA); Novartis; Novartis Oncology; Ohio State University Comprehensive Cancer Center
Class Antineoplastics; Carbazoles; Eye disorder therapies; Indole alkaloids; Skin disorder therapies; Small molecules
Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Platelet-derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Protein kinase C inhibitors; Proto-oncogene protein c-kit inhibitors; Vascular endothelial growth factor receptor-2 antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Acute myeloid leukaemia; Systemic mastocytosis
New Molecular Entity Yes

Registered Acute myeloid leukaemia; Systemic mastocytosis
No development reported Rectal cancer
Discontinued Acute biphenotypic leukaemia; Colorectal cancer; Diabetic macular oedema; Gastrointestinal stromal tumours; Multiple myeloma

12 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (Combination therapy, First-line therapy) in Brazil (PO)
12 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (In adults, In the elderly, Combination therapy, First-line therapy) in Argentina (PO)
12 Jan 2026 No development reported - Phase-III for Acute myeloid leukaemia (In adults, In the elderly, Combination therapy, First-line therapy) in Israel (PO)

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