Last reviewed 2026-04-20 · How we verify

PKC412

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Nausea
• Vomiting NOS
• Fatigue
• Oedema peripheral
• Pyrexia
• Headache
• Cough
• Diarrhoea NOS
• Gingival bleeding
• Anorexia
• Hypokalaemia
• Anaemia NOS

Key clinical trials

• RAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDS (PHASE1)
• Revumenib in Combination With 7+3 + Midostaurin in AML (PHASE1)
• A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML (PHASE2)
• Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia (PHASE2)
• FLT3-ITD Targeted Therapy in Fit AML Patients (PHASE2, PHASE3)
• Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia (PHASE2)
• 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 (PHASE1)
• Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• PKC412 CI brief — competitive landscape report
• PKC412 updates RSS · CI watch RSS
• Novartis Pharmaceuticals portfolio CI