HRS9531

Phase 3Small molecule

FFujian Shengdi Pharmaceutical Co., Ltd.

HRS9531 is one of 322 small molecule programs targeting Type 2 Diabetes. It is currently in Phase 3.

Indications

Total Trials

Active Trials

321

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type 2 DiabetesCompleted

TicsRecruiting

Efficacy and SafetyActive, not recruiting

Weight ManagementNot yet recruiting

FunctionRecruiting

Metabolic Dysfunction-Associated Steatohepatitis (MASH)Recruiting

Obstructive Sleep ApneaRecruiting

Polycystic Ovary SyndromeNot yet recruiting

Heart FailureActive, not recruiting

ObesityActive, not recruiting

Type 2 DiabetesPhase 3

Completed

TicsPhase 1

Recruiting

Efficacy and SafetyPhase 2

Active, not recruiting

Weight ManagementPhase 1

Not yet recruiting

FunctionPhase 1

Recruiting

Metabolic Dysfunction-Associated Steatohepatitis (MASH)Phase 2

Recruiting

Obstructive Sleep ApneaPhase 3

Recruiting

Polycystic Ovary SyndromePhase 2

Not yet recruiting

Heart FailurePhase 2

Active, not recruiting

ObesityPhase 3

Active, not recruiting

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

HRS9531

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

2 2

HLX10

Shanghai Henlius Biotech

Phase 3

2 3

NTQ5082

NNanjing Chia-tai Tianqing Pharmaceutical

Phase 3

1 4

PLB1004

AAvistone Biotechnology Co., Ltd.

Phase 3

1 5

VAY736

Novartis

Phase 3

2 6

HSK39297

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

3 7

KN057

SSuzhou Alphamab Co., Ltd.

Phase 3

2 8

IN-B00009

HHK inno.N Corporation

Phase 3

1 9

AVTX-803

AAUG Therapeutics

Phase 3

1 10

DFL24498

DDompé Farmaceutici S.p.A

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Obstructive Sleep Apnea

NCT06974851

Q1 2027

Phase 3Recruiting

Obstructive Sleep Apnea

NCT06994650

Phase 3Active, not recruiting

Obesity

NCT07285902

Phase 3Recruiting

Type 2 Diabetes

NCT07060456

Q3 2028

Phase 2Recruiting

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

NCT07660848

Q2 2031

Phase 3Recruiting

Atherosclerotic Cardiovascular Disease

NCT07551492

Clinical

Trials by Indication[1]

Obstructive Sleep Apnea3 trials

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT06994650·140 enrolled

A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea

Not yet recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06565871·108 enrolled

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT06974851·140 enrolled

Type 2 Diabetes3 trials

Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT05966272·199 enrolled

Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT07060456·300 enrolled

A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT06649344·884 enrolled

Tics2 trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT05152277·90 enrolled

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06762600·103 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT05881837·249 enrolled

Efficacy and Safety of HRS9531 Tablet in Obese Subjects

Active, not recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06841445·166 enrolled

Overweight2 trials

Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

Unknown status·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06054698·60 enrolled

To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT06396429·567 enrolled

13 more indications

Heart Failure1 trial

HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

Active, not recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06391710·203 enrolled

Function1 trial

A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06246175·32 enrolled

Polycystic Ovary Syndrome1 trial

A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome

Not yet recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT06595797·144 enrolled

Gastric Emptying1 trial

Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06723691·57 enrolled

Obese1 trial

HRS9531 Controls Weight Regain in Obese Subjects

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT06287437·72 enrolled

Obesity1 trial

A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

Active, not recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT07285902·572 enrolled

Metformin1 trial

Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06654960·20 enrolled

Type 2 Diabetes Mellitus1 trial

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT05516966·64 enrolled

Atherosclerotic Cardiovascular Disease1 trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT07551492·9,262 enrolled

Metabolic Dysfunction-Associated Steatohepatitis (MASH)1 trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Master Protocol Clinical Trial to Investigate the Efficacy and Safety of HRS-4729 Injection and HRS9531 Injection in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 2·NCT07660848·160 enrolled

Diabetes Mellitus, Type 21 trial

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 3·NCT06650007·218 enrolled

Weight Management1 trial

A Phase I Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Not yet recruiting·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06506175·100 enrolled

Unspecified4 trials

The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06792955·120 enrolled

Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06855147·7 enrolled

A Relative Bioavailability Study of HRS9531 in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT05893576·50 enrolled

Show 1 more trial

A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects

Completed·FFujian Shengdi Pharmaceutical Co., Ltd.·Phase 1·NCT06435676·72 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for HRS9531. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HRS9531 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HRS9531. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Fujian Shengdi Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: FFujian Shengdi Pharmaceutical Co., Ltd.

HRS9531

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2028

Q2 2031

Trials by Indication[1]

Obstructive Sleep Apnea3 trials

Type 2 Diabetes3 trials

Tics2 trials

Efficacy and Safety2 trials

Overweight2 trials

Heart Failure1 trial

Function1 trial

Polycystic Ovary Syndrome1 trial

Gastric Emptying1 trial

Obese1 trial

Obesity1 trial

Metformin1 trial

Type 2 Diabetes Mellitus1 trial

Atherosclerotic Cardiovascular Disease1 trial

Metabolic Dysfunction-Associated Steatohepatitis (MASH)1 trial

Diabetes Mellitus, Type 21 trial

Weight Management1 trial

Unspecified4 trials

References

Drug Info

Quick Facts

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