HRS-7535, now also called safiglipron and, outside China, KAI-7535, is an investigational once-daily oral GLP-1 receptor agonist from Jiangsu Hengrui Pharmaceuticals. It is a small synthetic molecule rather than a peptide. In a 556-person phase 3 trial in China, the 180 mg dose lowered body weight by 9.8% at 44 weeks vs 2.4% on placebo, and two phase 3 diabetes trials have been published.
The single most important fact: HRS-7535 is not approved anywhere. China’s National Medical Products Administration (NMPA) accepted marketing applications for type 2 diabetes and long-term weight management in September 2026, but acceptance only starts the review (Hengrui, September 4, 2026). Outside Greater China, the US company Kailera Therapeutics holds the rights and is still in phase 2, with results expected in mid-2027 (Kailera Q3 2026 release). Status was checked on November 7, 2026.
This page summarizes what the published trials, registry entries and company disclosures report, with notes for anabolics.app readers on lean mass, the liver, testosterone and sport. It is for education only and is not medical advice.
| Property | Detail |
|---|---|
| Drug class | Non-peptide (small-molecule) GLP-1 receptor agonist |
| Names / codes | HRS-7535 (Hengrui); KAI-7535 (Kailera); safiglipron (name used in 2026 publications and by Kailera) |
| Developer | Jiangsu Hengrui Pharmaceuticals (China); Kailera Therapeutics holds rights outside Greater China |
| Approval status | Investigational; marketing applications under review in China since September 2026 |
| Route | Oral tablet, once daily, without fasting or food restrictions |
| Doses studied | Diabetes: 15–90 mg/day; obesity: 30–180 mg/day, higher doses reached by monthly steps; global phase 2 up to 180 mg (option up to 360 mg) |
| Half-life | Not reported in the publications we reviewed |
| WADA status | Not named on the 2026 List; as an unapproved drug it falls under S0 (non-approved substances) |
What it is
HRS-7535 activates the GLP-1 receptor, the same receptor targeted by semaglutide. Unlike semaglutide, it is not a peptide, so it can be absorbed from an ordinary tablet. The phase 3 papers describe it as taken once daily “without fasting or dietary restrictions” (Guo et al., Nat Med 2026), in contrast to oral semaglutide, which must be taken on an empty stomach.
Hengrui’s subsidiary Shandong Shengdi filed the Chinese applications. Hengrui describes the drug as a Class 1 innovative drug whose absorption is not affected by food or water (Hengrui, September 4, 2026).
One drug, three names
- HRS-7535 is Hengrui’s code and appears in most Chinese trial records.
- KAI-7535 is the code used by Kailera Therapeutics, which runs development outside Greater China.
- Safiglipron is the generic-style name used in the two 2026 Nature Medicine phase 3 papers and in Kailera’s November 2026 report (Kailera Q3 2026 release).
How it compares with related drugs
| Drug | Molecule | Status (November 2026) | Library page |
|---|---|---|---|
| Semaglutide | Peptide | Approved | Semaglutide |
| Orforglipron | Small molecule | FDA-approved April 2026 (Foundayo) | Orforglipron |
| Elecoglipron | Small molecule | Phase 3 | Elecoglipron |
| Aleniglipron | Small molecule | Phase 3 | Aleniglipron |
| HRS-7535 (safiglipron) | Small molecule | Under review in China; global phase 2 | This page |
No trial has compared HRS-7535 with another GLP-1 drug. Its only active comparator so far is dapagliflozin, an SGLT2 inhibitor diabetes drug.
Pharmacokinetics
Detailed human pharmacokinetic data (half-life, peak time, clearance) have not appeared in the papers we reviewed. Registry records show that Hengrui has completed the standard set of phase 1 studies, including food-effect, mass-balance, kidney-impairment and liver-impairment studies, and drug-interaction studies with metformin, acetaminophen, digoxin, rosuvastatin and omeprazole (NCT07269756). Kailera also completed a study of a low-fat meal and evening dosing (NCT07294898). Results for these have not been posted.
Regulatory status
- China: under review, not approved. Hengrui announced on September 4, 2026 that the NMPA had accepted an application for long-term weight management in adults with a BMI of 28 or more, or 24 or more with a weight-related condition. A diabetes application had been accepted shortly before (Hengrui, September 4, 2026). We found no approval announcement as of November 7, 2026.
- Rest of the world: phase 2. Kailera’s global phase 2 trial (NCT07497880) began in April 2026, enrolled 306 adults in the US and Australia, and is no longer recruiting. It tests four dosing schedules against placebo over 44 weeks, starting at 15 mg. Kailera expects data in mid-2027 (Kailera Q3 2026 release). A US or EU approval would still need phase 3.
- More phase 3 trials in China. Hengrui has registered phase 3 trials in hypertension with overweight or obesity (648 people, primary completion December 2027; NCT07528027) and a kidney outcomes trial, RENEW-CKD (3,690 people, primary completion 2031; NCT07625774).
What the research shows
Obesity: phase 2 in China
This trial randomized 235 adults with a BMI of 28–40 and no diabetes at 29 centers in China to 30, 60, 120 or 180 mg or placebo (Gu et al., Nat Commun 2026). Participants were young (mean age 33.5) and lighter than in Western trials (mean weight 91.6 kg, BMI 32.5).
| Outcome at week 26 | Placebo | 30 mg | 60 mg | 120 mg | 180 mg |
|---|---|---|---|---|---|
| Mean weight change | −2.50% | −2.99% | −7.09% | −6.17% | −9.36% |
| Difference from placebo | — | −0.49 (p = 0.71) | −4.60 | −3.67 | −6.87 |
Doses of 60 mg and higher worked; 30 mg did not. Cholesterol, LDL, HDL and triglycerides changed about as much as on placebo over 36 weeks, so the drug showed no appreciable lipid effect in this trial.
Obesity: HARBOR-1 (phase 3, China)
HARBOR-1 (NCT06904105) randomized 556 adults with obesity (62% women; mean weight 94.1 kg, BMI 34.0) 2:2:1 to 120 mg, 180 mg or placebo. Results come from the company’s topline release; a peer-reviewed paper had not appeared when we checked (Kailera, July 7, 2026):
| Outcome at week 44 | Placebo | 120 mg | 180 mg |
|---|---|---|---|
| Weight change, treatment-policy estimand (primary) | −2.4% | −8.0% | −9.8% |
| Weight change, efficacy estimand | −2.5% | −9.5% | −10.9% |
| Lost at least 10% (treatment policy) | — | 39.6% | 46.6% |
| Lost at least 15% (treatment policy) | — | 18.5% | 26.0% |
The treatment-policy estimand counts everyone randomized, whether or not they kept taking the drug. The efficacy estimand assumes people stayed on treatment. An unplanned analysis at week 50 gave 11.1% on 180 mg.
These results sit below the weight loss seen with injectable tirzepatide or high-dose semaglutide, and in a similar range to other oral small molecules at the same stage. Different populations and designs make direct comparisons unreliable.
Type 2 diabetes
Five randomized trials in Chinese adults have been published:
| Trial | Design | HbA1c result | Weight change |
|---|---|---|---|
| Phase 2, on metformin (Guo et al., JAMA Netw Open 2026) | 194 adults; 15–90 mg vs placebo; 16 weeks | −1.19 to −1.82 points vs −0.25 on placebo | −2.63% on 90 mg vs −1.30% |
| Phase 2, on metformin plus an SGLT2 inhibitor (Xu et al., Diabetologia 2026) | 155 adults; 30 or 60 mg vs placebo; 16 weeks | −1.5 and −1.8 vs −0.4 | −2.4% on 60 mg vs −0.7% |
| Phase 2, diabetic kidney disease, SOLID-DKD (Lv et al., eClinicalMedicine 2026) | 280 adults; 30 or 90 mg vs placebo; 16 weeks | −1.09 vs placebo (90 mg) | −2.95 points vs placebo (90 mg) |
| Phase 3, OUTSTAND-1 (Yu et al., Nat Med 2026) | 284 adults with early diabetes on diet and exercise; 30–90 mg vs placebo; 32 weeks | −1.20 to −1.45 vs placebo | −0.65 to −3.56 points vs placebo |
| Phase 3, OUTSTAND-2 (Guo et al., Nat Med 2026) | 810 adults on metformin; 30–90 mg vs dapagliflozin 10 mg; 32 weeks | −0.22 to −0.40 more than dapagliflozin | −2.35% to −4.17% vs −3.60% on dapagliflozin |
HbA1c is the average blood sugar over about three months. In OUTSTAND-2, all three doses were non-inferior to dapagliflozin (not meaningfully worse), and the 90 mg dose also met the test for superiority. In SOLID-DKD, the 90 mg dose cut albumin in the urine, a marker of kidney damage, by 32% vs placebo.
Weight loss in diabetes trials was small, a few percent. That is typical of GLP-1 drugs in diabetes, and these trials used lower doses than the obesity trials.
Lean mass and body composition
No body-composition data have been published. None of the papers reports DXA scans, and no registered trial we found lists lean mass as an outcome. The papers do report waist circumference: in the phase 2 obesity trial, doses of 60 mg or more cut waist size by 2.1–4.9 cm more than placebo at 36 weeks (Gu et al. 2026).
For the class, a 2026 meta-analysis of 20 semaglutide trials estimated that about 35% of weight lost was lean mass, similar to lifestyle-only weight loss (Eisa and Barood, Diabetes Obes Metab 2026). DXA lean mass also counts water and organs, so it overstates muscle loss somewhat. Whether HRS-7535 follows that pattern is unknown.
Use alongside testosterone or anabolic steroids
No HRS-7535 trial has enrolled people on testosterone replacement therapy (TRT) or anabolic-androgenic steroids (AAS). In men with obesity-related low testosterone, peptide GLP-1 drugs have been linked to higher total testosterone with preserved LH and FSH (Deameh et al., J Sex Med 2026). That finding comes from other drugs and does not tell us what happens in someone already taking exogenous testosterone. See testosterone cypionate for TRT itself.
Side effects and risks
Gastrointestinal effects
Nausea and vomiting are the main issue, and in the obesity trials they were very common at the doses needed for meaningful weight loss.
| Adverse event | HARBOR-1 placebo | HARBOR-1 120 mg | HARBOR-1 180 mg | Phase 2 obesity: placebo | Phase 2 obesity: 180 mg |
|---|---|---|---|---|---|
| Nausea | 16.2% | 70.3% | 70.0% | 4.3% | 58.3% |
| Vomiting | 4.5% | 66.7% | 68.6% | 2.2% | 43.8% |
| Diarrhea | 15.3% | 36.9% | 35.9% | 8.7% | 18.8% |
| Stopped for adverse events | 2.7% | 4.1% | 3.1% | — | — |
Sources: Kailera, July 2026; Gu et al. 2026.
Even so, few people stopped. In the phase 2 obesity trial, only 5 of 235 participants (2.1%) stopped because of adverse events, and 8 needed a dose step-back during escalation, all for stomach and gut effects (Gu et al. 2026). Kailera’s global trial uses a lower starting dose and a more gradual escalation to try to cut these rates.
In the diabetes trials, which used lower doses, discontinuations for adverse events ranged from 1.4% to 6.9% (OUTSTAND-1) and about 4% (OUTSTAND-2, vs 1.5% on dapagliflozin) (Yu et al. 2026; Guo et al. 2026).
The liver and other laboratory findings
Small-molecule GLP-1 drugs are mainly handled by the liver, so liver tests matter. The evidence so far:
- In the metformin add-on phase 2 trial, no one had ALT or AST above three times the upper limit of normal, and there was no pancreatitis and no moderate or severe hypoglycemia (Guo et al., JAMA Netw Open 2026).
- In the phase 2 obesity trial, “ALT increased” was reported as an adverse event in 6.3–12.8% of HRS-7535 groups vs 6.5% on placebo, and no liver-function abnormality met the prespecified definition of a special-interest event. Amylase and lipase (pancreatic enzymes) rose slightly, as with other GLP-1 drugs, without clinical pancreatitis (Gu et al. 2026).
- Kailera reported no liver safety signal in HARBOR-1 but did not publish liver values (Kailera, July 2026).
Anabolic steroids can themselves injure the liver, including through cholestasis and liver tumors (Petrovic et al., World J Gastroenterol 2022). No study has tested HRS-7535 together with these drugs, so the combined risk is unknown.
Heart rate, serious events and gaps
The phase 2 obesity paper reported no clinically meaningful change in pulse or heart rate, although small increases have been described for this drug and others in its class (Gu et al. 2026). Serious adverse events in that trial occurred in 0–6.3% of HRS-7535 groups vs 2.2% on placebo; none were judged drug-related.
Almost all published data come from Chinese adults, and the longest controlled data cover 44–52 weeks. Data in heavier Western populations, in pregnancy, in adolescents and in athletes are lacking.
Use in sport
HRS-7535 is not named on the WADA Prohibited List. Section S0 prohibits at all times any pharmacological substance not covered elsewhere on the List that has no current approval by any government health authority for human therapeutic use, including drugs in clinical development (WADA 2026 Prohibited List). While HRS-7535 remains unapproved, it falls under S0. If China approves it, it would no longer meet the S0 definition, as is already the case for mazdutide, which is approved in China.
Key takeaways
- An oral, non-peptide GLP-1 drug from China. HRS-7535 (safiglipron, KAI-7535) is a once-daily tablet with no fasting rules.
- Under review in China, not approved. The NMPA accepted diabetes and weight-management applications in September 2026; Kailera’s global phase 2 reports in mid-2027 (checked November 7, 2026).
- About 10% weight loss at 44 weeks. In HARBOR-1, 180 mg gave 9.8% vs 2.4% on placebo, counting everyone randomized.
- Solid diabetes data. Two phase 3 trials are published; 90 mg beat dapagliflozin on HbA1c.
- Very high nausea and vomiting rates. About 70% had nausea and two-thirds vomited at the top obesity doses, although few stopped treatment.
- No lean-mass data and no studies with testosterone or steroids. Its effect on muscle is unknown.
Sources
- Gu W, Zhang L, Li L, et al. HRS-7535, an oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity without diabetes: a randomized, double-blind, placebo-controlled phase 2 trial. Nat Commun. 2026;17(1):7867. PubMed.
- Guo L, Sun Z, Zhang L, et al. HRS-7535 for type 2 diabetes inadequately controlled with metformin: a randomized clinical trial. JAMA Netw Open. 2026;9(6):e2615622. PubMed.
- Xu M, Song W, Lv F, et al. Efficacy and safety of HRS-7535, a novel oral small-molecule glucagon-like peptide-1 receptor agonist, in participants with type 2 diabetes mellitus inadequately controlled by metformin and sodium-glucose co-transporter 2 inhibitors: a multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase II trial. Diabetologia. Published online October 14, 2026. PubMed.
- Lv R, Peng L, Xu Y, et al. Efficacy and safety of HRS-7535, an oral small-molecule GLP-1 receptor agonist, in patients with diabetic kidney disease (SOLID-DKD): a randomised, double-blind, placebo-controlled, phase 2 trial. EClinicalMedicine. 2026;97:104045. PubMed.
- Yu M, Peng L, Jiang C, et al. Oral small-molecule GLP-1 receptor agonist safiglipron in early type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Nat Med. Published online September 29, 2026. PubMed.
- Guo L, Yu D, Xu Y, et al. Oral small-molecule GLP-1RA safiglipron versus dapagliflozin in type 2 diabetes: a randomized, double-blind, active-comparator-controlled phase 3 trial. Nat Med. Published online October 5, 2026. PubMed.
- Kailera Therapeutics. 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. Press release, July 7, 2026. BioSpace.
- Kailera Therapeutics. Kailera reports third quarter 2026 financial results and provides business updates. Press release (Form 8-K, Exhibit 99.1), November 4, 2026. SEC.
- Jiangsu Hengrui Pharmaceuticals. Marketing application for HRS-7535 tablets for long-term weight management in adults accepted by NMPA (in Chinese). September 4, 2026. Hengrui.
- ClinicalTrials.gov. A trial of HRS-7535 tablets in subjects with overweight or obesity (HARBOR-1). NCT06904105. ClinicalTrials.gov.
- ClinicalTrials.gov. Efficacy and safety of oral KAI-7535 in adult participants living with obesity or overweight with at least 1 weight-related comorbidity. NCT07497880. ClinicalTrials.gov.
- ClinicalTrials.gov. Phase III study of HRS-7535 for hypertension with overweight or obesity. NCT07528027. ClinicalTrials.gov; Renal efficacy and safety of HRS-7535 in participants with chronic kidney disease (RENEW-CKD). NCT07625774. ClinicalTrials.gov.
- ClinicalTrials.gov. A study to evaluate the drug interactions of HRS-7535 with acetaminophen, digoxin, rosuvastatin, and omeprazole in obese or overweight subjects. NCT07269756. ClinicalTrials.gov; A study to investigate the effect of a low-fat meal and evening dosing on KAI-7535. NCT07294898. ClinicalTrials.gov.
- Eisa N, Barood O. Lean mass changes with incretin therapy versus lifestyle intervention: a systematic review and meta-analysis of randomised controlled trials. Diabetes Obes Metab. 2026;28(6):4818–4827. PubMed.
- Deameh MG, Ramez M, Rowaiee R, et al. Effects of glucagon-like peptide-1 receptor agonists on male reproductive hormones, semen parameters, and metabolic outcomes: a systematic review. J Sex Med. 2026;23(2):qdaf381. PubMed.
- Petrovic A, Vukadin S, Sikora R, et al. Anabolic androgenic steroid-induced liver injury: an update. World J Gastroenterol. 2022;28(26):3071–3080. PubMed.
- World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA 2026 Prohibited List.