Clinical Trials Pipeline & In-Development

HRS-9531

also known as: HRS9531, KAI-9531

Hengrui's once-weekly GLP-1/GIP dual agonist in Phase 3 in China for obesity, with Kailera Therapeutics holding global ex-China rights since 2024; the structurally closest Chinese competitor to tirzepatide.

A once-weekly dual GLP-1 / GIP receptor agonist peptide developed by Jiangsu Hengrui Pharmaceuticals — Phase 3 in China for obesity (2024–2025) with reported ~22% weight loss at 48 weeks at top dose in Phase 2 — and licensed globally (ex-China) to Kailera Therapeutics in May 2024, where it is being developed alongside efpeglenatide as part of a Kailera GLP-1 portfolio.

Mechanism of action

Balanced dual GLP-1 / GIP receptor agonism — mechanistically the same class as tirzepatide. Lipidation provides albumin binding and weekly pharmacokinetics.

Primary uses

Obesity (Phase 3, China)
Type 2 diabetes mellitus (Phase 2)

Typical dosing

1–8 mg once weekly (subcutaneous)

Phase 2 explored 1–8 mg weekly dose range.

Regulatory status

Not approved. Phase 3 in China in obesity ongoing. Hengrui licensed global ex-China rights to Kailera Therapeutics in May 2024.

References

[manufacturer] Jiangsu Hengrui Pharmaceuticals. HRS9531 Phase 2 results press release (2024).
[manufacturer] Kailera Therapeutics. Press release: global licensing of HRS-9531 from Hengrui, May 2024.

Related peptides

Tirzepatide

A once-weekly GLP-1/GIP dual agonist that produced unprecedented weight loss in SURMOUNT trials — up to ~21% at highest dose.

VK2735

Viking's emerging dual GLP-1/GIP agonist — Phase 2 SC data in obesity reported up to ~14.7% placebo-adjusted weight loss at 13 weeks (VENTURE, 2024), with an oral-tablet Phase 2 program initiated 2024; the principal clinical challenger to tirzepatide's mechanism outside the Lilly / Novo axis.

Efpeglenatide

A weekly-to-monthly exendin-4-based GLP-1 agonist with positive Phase 3 cardiovascular outcomes (AMPLITUDE-O, 2021) — Sanofi returned the license to Hanmi in 2020; Hanmi re-partnered with Innovent in 2020 for China development and with Kailera in 2024 for global development.

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Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.