--- title: "KAI-7535 | PepTracker Pro" url: https://peptrackerpro.com/peptides/kai-7535 description: "An oral once-daily small-molecule GLP-1 receptor agonist (Hengrui's HRS-7535, licensed to Kailera) that delivered up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and met its Phase 3 diabetes endpoint, now in a global Phase 2 dose-optimization study." lang: en --- Skip to main content **Educational information only.** This site does not provide medical advice. Read full disclaimer (https://peptrackerpro.com/disclaimer) **Research-only content.** This page is for educational purposes and does not constitute medical advice. Read full disclaimer → (https://peptrackerpro.com/research-disclaimer) # KAI-7535 Medium Evidence An oral once-daily small-molecule GLP-1 receptor agonist (Hengrui's HRS-7535, licensed to Kailera) that delivered up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and met its Phase 3 diabetes endpoint, now in a global Phase 2 dose-optimization study. Aliases HRS-7535 +4 more Evidence Medium Evidence Last Updated 2026-08-02 Reading Time 4 min ## What It Is KAI-7535 (Hengrui Pharma's HRS-7535) is an investigational once-daily oral small-molecule GLP-1 receptor agonist being developed for obesity and type 2 diabetes. Like orforglipron and aleniglipron, it is a non-peptide compound intended to sidestep the manufacturing complexity, cold-chain storage, and injection burden of peptide-based GLP-1 drugs while offering the convenience of a daily pill. HRS-7535 was discovered by Jiangsu Hengrui Pharmaceuticals and licensed to Kailera Therapeutics outside Greater China in 2024; Kailera develops it as KAI-7535. More than 2,000 patients have been dosed with HRS-7535 in Chinese clinical trials to date. On July 7, 2026, Kailera announced positive topline data from two Hengrui-run Phase 3 trials in China. In the HARBOR-1 obesity trial (HRS-7535-303, NCT06904105; 556 adults with overweight or obesity, mean baseline weight 94.1 kg and BMI 34.0), once-daily HRS-7535 met its primary endpoint of superior weight reduction at Week 44: participants on 120 mg and 180 mg lost a mean 9.5% and 10.9% of body weight (efficacy estimand) versus 2.5% for placebo, with continued loss to Week 50 (9.5% and 11.1% vs 2.6%). On the treatment-policy estimand the 120 mg and 180 mg arms lost 8.0% and 9.8% versus 2.4%, and at Week 44 up to 68.2% of treated participants achieved at least 5% weight loss, 46.6% at least 10%, and 26.0% at least 15%. In the OUTSTAND-2 diabetes trial (HRS-7535-302, NCT06589765; 810 adults with type 2 diabetes), HRS-7535 at 30/60/90 mg met non-inferiority to dapagliflozin on HbA1c at Week 32, with the 90 mg dose achieving statistically superior HbA1c reduction (1.58%, 1.50%, and 1.68% across doses vs 1.28% for dapagliflozin). No liver safety signal was observed in either trial, consistent with prior HRS-7535 data — a notable point given that hepatic-safety questions have shadowed some oral small-molecule GLP-1 programs. Adverse events were predominantly mild-to-moderate gastrointestinal effects (in HARBOR-1, nausea ~70%, vomiting ~67%, diarrhea ~36% on active drug), with treatment discontinuation from adverse events of only 3–4%. Kailera is separately running a global Phase 2 trial of KAI-7535 (initiated April 2026 in the U.S. and Australia, ~320 participants) that uses a lower 15 mg starting dose and a more gradual titration up to 180 mg (with a higher-dose cohort to 360 mg) to optimize the balance of weight loss and tolerability, with data expected in 2027. Hengrui plans to submit China NDAs for HRS-7535 in both obesity and type 2 diabetes. KAI-7535 is the oral small-molecule sibling to Kailera's lead injectable GLP-1/GIP dual agonist ribupatide (KAI-9531) within a broader Kailera obesity portfolio. Also known as: HRS-7535, HRS7535, Hengrui HRS-7535, Kailera oral GLP-1 small molecule, KAI7535 ## Regulatory Status Investigational — not approved Two Chinese Phase 3 trials (HARBOR-1 obesity, OUTSTAND-2 T2D) reported positive topline results July 7, 2026; Hengrui plans China NDA submissions for obesity and type 2 diabetes. Kailera's global (U.S./Australia) Phase 2 dose-optimization trial initiated April 2026 with data expected 2027. Not approved for any indication anywhere. Effective: July 2026 View FDA Source (https://www.globenewswire.com/news-release/2026/07/07/3323036/0/en/kailera-therapeutics-announces-positive-topline-data-from-two-hengrui-pharma-phase-3-clinical-trials-of-oral-small-molecule-glp-1-receptor-agonist-hrs-7535-kai-7535.html) ## Why Researchers Study It KAI-7535 is one of the most clinically advanced oral small-molecule GLP-1 receptor agonists, with two positive Phase 3 readouts already in hand from China and more than 2,000 patients dosed. Researchers watch it as a scalable, room-temperature-stable daily pill that could broaden access to incretin therapy, and as a test of whether the oral small-molecule GLP-1 class can deliver competitive weight loss while avoiding the liver-safety issues that ended earlier programs. Its clean liver-safety profile across large Phase 3 trials is a particular point of interest. ## Proposed Mechanisms - Small-molecule agonism of the GLP-1 receptor, reducing appetite and caloric intake - Delays gastric emptying to promote satiety - Enhances glucose-dependent insulin secretion, lowering HbA1c - Non-peptide oral structure enables once-daily dosing without the cold chain of injectable peptides ## Evidence Snapshot Medium Evidence Low Medium High | Study Type | Model | Outcome | Link | | --- | --- | --- | --- | | Phase 3 (HARBOR-1, obesity, China) | 556 adults with overweight/obesity, mean BMI 34.0 — 44–50 weeks | Met primary endpoint: 120 mg and 180 mg achieved mean weight loss of 9.5% and 10.9% at Week 44 (efficacy estimand) vs 2.5% placebo; up to 11.1% at Week 50; up to 26.0% of participants reached ≥15% weight loss; no liver safety signal | Source: https://www.globenewswire.com/news-release/2026/07/07/3323036/0/en/kailera-therapeutics-announces-positive-topline-data-from-two-hengrui-pharma-phase-3-clinical-trials-of-oral-small-molecule-glp-1-receptor-agonist-hrs-7535-kai-7535.html | | Phase 3 (OUTSTAND-2, type 2 diabetes, China) | 810 adults with T2D on metformin, mean baseline HbA1c 8.60% — 32 weeks core | Met primary endpoint: non-inferiority to dapagliflozin across 30/60/90 mg; HbA1c reductions of 1.58%, 1.50%, 1.68% vs 1.28% for dapagliflozin (90 mg statistically superior); improvements in weight, blood pressure, lipids and UACR; no liver safety signal | Source: https://www.globenewswire.com/news-release/2026/07/07/3323036/0/en/kailera-therapeutics-announces-positive-topline-data-from-two-hengrui-pharma-phase-3-clinical-trials-of-oral-small-molecule-glp-1-receptor-agonist-hrs-7535-kai-7535.html | | Phase 2 (global dose-optimization, U.S./Australia) | ~320 adults with obesity (BMI ≥30, or ≥27 with a comorbidity) — 44-week treatment | Ongoing: initiated April 2026, evaluating a lower 15 mg starting dose with gradual titration to 180 mg (higher cohort to 360 mg) to optimize weight loss versus tolerability; topline data expected 2027 | Source: https://investors.kailera.com/news-releases/news-release-details/kailera-reports-first-quarter-2026-financial-results-and | ## Commonly Discussed Benefits Weight Management: https://peptrackerpro.com/benefits/weight-management Appetite Regulation: https://peptrackerpro.com/benefits/appetite-regulation Metabolism: https://peptrackerpro.com/benefits/metabolism Glycemic Control: https://peptrackerpro.com/benefits/glycemic-control Fat Loss: https://peptrackerpro.com/benefits/fat-loss Researching KAI-7535? Track it, set reminders, and keep notes in the free app. Track in App (https://app.peptrackerpro.com/?add=kai-7535) ## Safety & Cautions - Investigational — not approved for any use anywhere - Pivotal efficacy data to date come from China-only Phase 3 trials; global Phase 2/3 confirmation is still underway - Gastrointestinal adverse events are common (nausea, vomiting, diarrhea), mostly during dose titration - As a GLP-1 receptor agonist, class effects and long-term safety monitoring apply - Any 'KAI-7535' or 'HRS-7535' offered by a vendor is unverified — this is a clinical-stage pharmaceutical, not a supplement or research chemical ## Comparisons See how KAI-7535 compares to related peptides: KAI-7535 vs Aleniglipron: https://peptrackerpro.com/compare/kai-7535-vs-aleniglipron KAI-7535 vs Conveglipron: https://peptrackerpro.com/compare/kai-7535-vs-conveglipron KAI-7535 vs Danuglipron: https://peptrackerpro.com/compare/kai-7535-vs-danuglipron KAI-7535 vs Orforglipron: https://peptrackerpro.com/compare/kai-7535-vs-orforglipron KAI-7535 vs Ribupatide: https://peptrackerpro.com/compare/kai-7535-vs-ribupatide KAI-7535 vs Semaglutide: https://peptrackerpro.com/compare/kai-7535-vs-semaglutide KAI-7535 vs HRS9531 (KAI-9531): https://peptrackerpro.com/compare/kai-7535-vs-hrs9531 ## Calculator Tools Use our research tools to explore dosing and reconstitution data: Reconstitution Calculator: https://peptrackerpro.com/calculators ## Citations 1. [1] Kailera Therapeutics — Positive Topline Data from Two Hengrui Phase 3 Trials of Oral GLP-1 HRS-7535/KAI-7535 (July 7, 2026) PubMed (https://www.globenewswire.com/news-release/2026/07/07/3323036/0/en/kailera-therapeutics-announces-positive-topline-data-from-two-hengrui-pharma-phase-3-clinical-trials-of-oral-small-molecule-glp-1-receptor-agonist-hrs-7535-kai-7535.html) 2. [2] Kailera Reports First Quarter 2026 Financial Results and Provides Clinical Data Updates (KAI-7535 global Phase 2) PubMed (https://investors.kailera.com/news-releases/news-release-details/kailera-reports-first-quarter-2026-financial-results-and) 3. [3] HARBOR-1 (HRS-7535-303) — ClinicalTrials.gov NCT06904105 PubMed (https://clinicaltrials.gov/study/NCT06904105) 4. [4] OUTSTAND-2 (HRS-7535-302) — ClinicalTrials.gov NCT06589765 PubMed (https://clinicaltrials.gov/study/NCT06589765) ### Keep researching in the app - Log KAI-7535 to your private tracker - Set a dosing reminder - Compare it side-by-side with your stack Open PepTracker Pro Free: https://app.peptrackerpro.com/?add=kai-7535 Browse more peptides: https://peptrackerpro.com/peptides ## Related Peptides ### Aleniglipron Medium Evidence An oral non-peptide small-molecule GLP-1 receptor agonist achieving 16.3% placebo-adjusted weight loss at 44 weeks in Phase 2 ACCESS II, with Phase 3 on track for Q3 2026 after positive FDA end-of-Phase 2 feedback. Weight Management: https://peptrackerpro.com/benefits/weight-management Appetite Regulation: https://peptrackerpro.com/benefits/appetite-regulation Metabolism: https://peptrackerpro.com/benefits/metabolism Fat Loss: https://peptrackerpro.com/benefits/fat-loss View Details: https://peptrackerpro.com/peptides/aleniglipron \+ Compare: https://peptrackerpro.com/compare?select=aleniglipron Track in App: https://app.peptrackerpro.com/?add=aleniglipron ### Conveglipron Low Evidence An oral, once-daily small-molecule GLP-1 receptor agonist (developmental code HDM1002) from Huadong Medicine, in clinical trials for obesity and type 2 diabetes — part of the next wave of GLP-1 'pills' competing with orforglipron. Fat Loss: https://peptrackerpro.com/benefits/fat-loss Appetite Regulation: https://peptrackerpro.com/benefits/appetite-regulation Metabolism: https://peptrackerpro.com/benefits/metabolism View Details: https://peptrackerpro.com/peptides/conveglipron \+ Compare: https://peptrackerpro.com/compare?select=conveglipron Track in App: https://app.peptrackerpro.com/?add=conveglipron ### Danuglipron Medium Evidence An oral small-molecule GLP-1 receptor agonist discontinued by Pfizer in 2026 after a potential drug-induced liver injury signal, despite showing meaningful weight loss in Phase 2b. Weight Management: https://peptrackerpro.com/benefits/weight-management Appetite Regulation: https://peptrackerpro.com/benefits/appetite-regulation Metabolism: https://peptrackerpro.com/benefits/metabolism View Details: https://peptrackerpro.com/peptides/danuglipron \+ Compare: https://peptrackerpro.com/compare?select=danuglipron Track in App: https://app.peptrackerpro.com/?add=danuglipron ### Orforglipron High Evidence The first oral non-peptide GLP-1 receptor agonist, FDA-approved in April 2026 for chronic weight management with no food or water restrictions. Weight Management (https://peptrackerpro.com/benefits/weight-management)Appetite Regulation (https://peptrackerpro.com/benefits/appetite-regulation)Metabolism (https://peptrackerpro.com/benefits/metabolism)Fat Loss (https://peptrackerpro.com/benefits/fat-loss)+1 more View Details: https://peptrackerpro.com/peptides/orforglipron \+ Compare: https://peptrackerpro.com/compare?select=orforglipron Track in App: https://app.peptrackerpro.com/?add=orforglipron ### Ribupatide Medium Evidence A once-weekly injectable GLP-1/GIP dual receptor agonist in Phase 3 trials for obesity, with an oral formulation in development and backed by a record-setting $625M biotech IPO. View Details: https://peptrackerpro.com/peptides/ribupatide \+ Compare: https://peptrackerpro.com/compare?select=ribupatide Track in App: https://app.peptrackerpro.com/?add=ribupatide ### Semaglutide High Evidence A GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management. Weight Management (https://peptrackerpro.com/benefits/weight-management)Appetite Regulation (https://peptrackerpro.com/benefits/appetite-regulation)Metabolism (https://peptrackerpro.com/benefits/metabolism)Fat Loss (https://peptrackerpro.com/benefits/fat-loss)+3 more View Details: https://peptrackerpro.com/peptides/semaglutide \+ Compare: https://peptrackerpro.com/compare?select=semaglutide Track in App: https://app.peptrackerpro.com/?add=semaglutide ### HRS9531 (KAI-9531) Medium Evidence An investigational once-weekly injectable dual GLP-1/GIP receptor agonist - the same peptide class as tirzepatide (Zepbound/Mounjaro) - developed by China's Jiangsu Hengrui Pharmaceuticals as HRS9531 and licensed to U.S.-based Kailera Therapeutics, which is developing it globally (outside Greater China) as KAI-9531. In the pivotal 48-week Phase 3 GEMINI-1 trial in China (NCT06396429; 567 adults with obesity or overweight without diabetes), once-weekly HRS9531 produced mean weight loss of about 17.4-19.2% at the 4 mg and 6 mg doses (per-protocol/hypothetical estimand) versus roughly 1.4% for placebo, with about 44% of 6 mg patients losing at least 20% of body weight and broad improvements in blood pressure, lipids, insulin resistance, and inflammation (hsCRP). An earlier Phase 2 trial reported about 23.6% mean weight loss at the higher 8 mg dose by week 36 with no plateau. Hengrui has submitted a marketing application to China's NMPA for chronic weight management, and Kailera began a global Phase 3 program (KAI-9531) evaluating higher maintenance doses (8 mg and 10 mg) and longer treatment by late 2025. HRS9531/KAI-9531 is investigational, is not approved outside of any regulatory review in China, and is not a supplement or research chemical; it is studied only in clinical trials. Weight Management (https://peptrackerpro.com/benefits/weight-management)Fat Loss (https://peptrackerpro.com/benefits/fat-loss)Body Composition (https://peptrackerpro.com/benefits/body-composition)Metabolism (https://peptrackerpro.com/benefits/metabolism)+1 more View Details: https://peptrackerpro.com/peptides/hrs9531 \+ Compare: https://peptrackerpro.com/compare?select=hrs9531 Track in App: https://app.peptrackerpro.com/?add=hrs9531 ## Structured data ```json [ { "@context": "https://schema.org", "@type": "Organization", "name": "PepTracker Pro", "url": "https://peptrackerpro.com", "logo": "https://peptrackerpro.com/favicon.png", "description": "Evidence-based educational resource dedicated to improving peptide research literacy.", "contactPoint": { "@type": "ContactPoint", "email": "hello@peptrackerpro.com", "contactType": "customer support" }, "sameAs": [] }, { "@context": "https://schema.org", "@type": "MedicalWebPage", "name": "KAI-7535", "description": "An oral once-daily small-molecule GLP-1 receptor agonist (Hengrui's HRS-7535, licensed to Kailera) that delivered up to 10.9% weight loss at Week 44 in a Chinese Phase 3 obesity trial and met its Phase 3 diabetes endpoint, now in a global Phase 2 dose-optimization study.", "url": "https://peptrackerpro.com/peptides/kai-7535", "lastReviewed": "2026-08-02", "reviewedBy": { "@type": "Organization", "name": "PepTracker Pro Research Team", "url": "https://peptrackerpro.com" }, "isPartOf": { "@type": "WebSite", "name": "PepTracker Pro", "url": "https://peptrackerpro.com" } }, { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://peptrackerpro.com" }, { "@type": "ListItem", "position": 2, "name": "Peptides", "item": "https://peptrackerpro.com/peptides" }, { "@type": "ListItem", "position": 3, "name": "KAI-7535", "item": "https://peptrackerpro.com/peptides/kai-7535" } ] }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "People interested in oral weight-loss pills as an alternative to injections?", "acceptedAnswer": { "@type": "Answer", "text": "KAI-7535 is a research peptide studied in preclinical models. 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