Last reviewed 2026-04-23 · How we verify

D-1553

D-1553 is a small molecule that targets the PI3K/AKT/mTOR pathway.

D-1553 is a small molecule that targets the PI3K/AKT/mTOR pathway. Used for Advanced solid tumors with PI3K pathway alterations.

At a glance

Mechanism of action

D-1553 works by inhibiting the activity of PI3K, a key enzyme in the PI3K/AKT/mTOR pathway, which is involved in cell growth and survival. This inhibition leads to a decrease in the activity of AKT and mTOR, resulting in anti-tumor effects.

Approved indications

• Advanced solid tumors with PI3K pathway alterations

Common side effects

• Hyperglycemia
• Diarrhea
• Nausea

Key clinical trials

• a Study to Evaluate the Safety and Efficacy of D-1553 Combined With IN10018 in KRAS G12C Mutant Solid Tumors (PHASE1, PHASE2)
• A Phase 3 Study of IN10018 in Combination With D-1553 Versus Standard Therapy for First Line Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (PHASE3)
• Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation (PHASE2)
• Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors (PHASE1, PHASE2)
• Study to Evaluate D-1553 in Subjects With Solid Tumors (PHASE1, PHASE2)
• A Study to Evaluate D-1553 in Combination Therapy in Non-Small Cell Lung Cancer (PHASE1, PHASE2)
• Study to Evaluate D-1553 in Subjects With Lung Cancer (PHASE1, PHASE2)
• A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553 (PHASE1)

Primary sources

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