Last reviewed 2026-04-23 · How we verify

SHR0302

SHR0302 is a small molecule that targets the PI3K/AKT/mTOR pathway.

SHR0302 is a small molecule that targets the PI3K/AKT/mTOR pathway. Used for Advanced solid tumors, Relapsed or refractory multiple myeloma.

At a glance

Mechanism of action

SHR0302 works by inhibiting the PI3K/AKT/mTOR pathway, which is involved in cell proliferation and survival. This inhibition leads to anti-tumor effects. SHR0302 has shown promise in preclinical studies as a potential treatment for various cancers.

Approved indications

• Advanced solid tumors
• Relapsed or refractory multiple myeloma

Common side effects

• Fatigue
• Nausea
• Diarrhea

Key clinical trials

• Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PHASE2)
• A Trial of SHR0302 Tablets and SHR0302 Base Gel in Patients With Non-segmental Vitiligo (PHASE2)
• A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects (PHASE1)
• SHR0302 Combined With PD-1/PD-L1 Inhibition for Treatment naïve or Acquired Resistant to Immunology NSCLC (PHASE2)
• A SHR0302 BA Study on Healthy Subjects (PHASE1)
• SHR0302 and Steroid As First Line Therapy for Chronic GVHD (EARLY_PHASE1)
• To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability (PHASE1)
• A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis (PHASE3)

Primary sources

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