Last reviewed 2026-04-23 · How we verify

KAI-9531

KAI-9531 is a small molecule that targets the PD-1 receptor.

KAI-9531 is a small molecule that targets the PD-1 receptor. Used for Metastatic non-small cell lung cancer, PD-L1 positive, Metastatic melanoma.

At a glance

Mechanism of action

By binding to PD-1, KAI-9531 prevents the interaction between PD-1 and its ligands, leading to the activation of T cells and enhanced anti-tumor immune response.

Approved indications

• Metastatic non-small cell lung cancer, PD-L1 positive
• Metastatic melanoma

Common side effects

• Fatigue
• Diarrhea
• Nausea
• Rash
• Hypertension

Key clinical trials

• Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes (PHASE3)
• Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes (PHASE3)
• Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes (PHASE2)
• Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes (PHASE3)
• A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices (PHASE1)

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:

• KAI-9531 CI brief — competitive landscape report
• KAI-9531 updates RSS · CI watch RSS
• Kailera portfolio CI