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Evidence: MediumPeptide 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

Human studyPMID 42764407 0.9–5.4 mg once weekly (subcutaneous)

Multiple-dose cohorts of the first-in-human study, four weekly doses (PMID 42764407); phase 2 doses are not in a paper this page cites.

Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Regulatory status

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

Status as of this entry's last review, October 4, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.

What we checked

HRS-9531, now named ribupatide, is a GLP-1/GIP dual agonist from Jiangsu Hengrui. One paper indexed on PubMed reports its first human study; several trials are registered. This section records what can be checked.

Identity, computed

SequenceNot established

The 2026 first-in-human paper describes it as a chemically synthesised polypeptide but does not give the sequence in its abstract, so no formula or mass is given here.

Regulatory status, read October 5, 2026

Drugs@FDA: 0 records for “ribupatide”. EMA medicines list: 0 records for “ribupatide”. Run for semaglutide, the same queries return 6 and 5 records (and the registry search 84 trials), so a zero here is an absence, not a broken search. Not named on the WADA 2026 and 2027 Prohibited Lists. As a substance with no current approval for human therapeutic use, it falls under section S0 (non-approved substances), which is prohibited at all times; the lists were read on September 27, 2026.

What the maker or sellers claim

Claim, from Hengrui and its licensee Kailera Therapeutics: ribupatide is a once-weekly obesity drug with weight loss competitive with tirzepatide. Head-to-head data against tirzepatide have not been published.

The one published human study

The 2026 paper combined lab and animal work with a phase 1 trial: single doses from 0.1 to 8.1 mg and four weeks of once-weekly doses up to 5.4 mg under the skin, against placebo, with safety and tolerability as the main endpoints. It activated both GLP-1 and GIP receptors in cells, was well absorbed under the skin in rats and monkeys, and reduced body weight in obese mice (He et al., 2026). These are trial doses for safety testing, not doses to use.

ClinicalTrials.gov lists more than 30 trials of HRS9531, including phase 3 studies in obesity, type 2 diabetes, obstructive sleep apnoea and atherosclerotic disease, a head-to-head with semaglutide, and an oral tablet study; their results were not in the indexed literature on the search date.

What we looked for and did not find

No published phase 2 or 3 results in a peer-reviewed journal as of the search date, and no approval anywhere.

SourceQueryResults, October 5, 2026What it was
PubMedHRS95311
PubMedribupatide1the 2026 first-in-human paper
ClinicalTrials.govHRS953133phase 1-3 trials, incl. head-to-head with semaglutide and a tablet
Drugs@FDA (openFDA)ribupatide0
EMA medicines listribupatide0

What the studies show

HRS9531 (ribupatide) is developed by Fujian Shengdi Pharmaceutical. Beyond its first trial in people, cited below, its programme is visible in trial registrations, including phase 3 trials as an injection and as a tablet.

Registry · 2024

Phase 3 in overweight and obesity

HRS9531 against placebo in 567 people with overweight or obesity; completed, with primary completion in July 2025.

NCT06396429 · ClinicalTrials.gov record

Registry · 2024

Phase 3 against semaglutide

Once-weekly HRS9531 against once-weekly semaglutide as add-on to metformin in 884 people with type 2 diabetes; completed, primary completion July 2026.

NCT06649344 · ClinicalTrials.gov record

Registry · 2024

Heart failure

A phase 2 trial in 203 people with obesity and heart failure with preserved ejection fraction; active, not recruiting.

NCT06391710 · ClinicalTrials.gov record

Registry · 2026

Phase 3 as a tablet

HRS9531 tablets in 675 people with overweight or obesity for chronic weight management; recruiting since July 2026.

NCT07670884 · ClinicalTrials.gov record

References

  1. [manufacturer] Jiangsu Hengrui Pharmaceuticals. HRS9531 Phase 2 results press release (2024).
  2. [manufacturer] Kailera Therapeutics. Press release: global licensing of HRS-9531 from Hengrui, May 2024.
  3. [clinicaltrials] ClinicalTrials.gov NCT06396429: "To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese" Fujian Shengdi Pharmaceutical Co., Ltd.. Phase 3, completed, May 2024 to July 2025 (primary completion), 567 participants. Registry record read October 2, 2026.
  4. [clinicaltrials] ClinicalTrials.gov NCT06649344: "A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes" Fujian Shengdi Pharmaceutical Co., Ltd.. Phase 3, completed, October 2024 to July 2026 (primary completion), 884 participants. Registry record read October 2, 2026.
  5. [clinicaltrials] ClinicalTrials.gov NCT06391710: "HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction" Fujian Shengdi Pharmaceutical Co., Ltd.. Phase 2, active not recruiting, May 2024 to January 2026 (primary completion), 203 participants. Registry record read October 2, 2026.
  6. [clinicaltrials] ClinicalTrials.gov NCT07670884: "A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects" Fujian Shengdi Pharmaceutical Co., Ltd.. Phase 3, recruiting, July 2026 to October 2027 (primary completion), 675 participants. Registry record read October 2, 2026.
  7. [clinical-trial] He K, et al. "Preclinical and First-In-Human Evaluation of Ribupatide (HRS9531), a Dual GLP-1/GIP Receptor Agonist." Diabetes Obes Metab, 2026. PMID: 42764407.

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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.