HRS-7535

Phase 3Small molecule

SShandong Suncadia Medicine Co., Ltd.

HRS-7535 is one of 122 small molecule programs targeting Heart Failure. It is currently in Phase 3.

Indications

Total Trials

Active Trials

121

Competitors

Pipeline

Status by Indication[3][1]

Indication

Heart FailureRecruiting

Type 2 DiabetesActive, not recruiting

InteractionNot yet recruiting

Heart FailurePhase 2

Recruiting

Type 2 DiabetesPhase 3

Active, not recruiting

InteractionPhase 1

Not yet recruiting

Competition

Competitive Landscape

206 competitors in Heart Failure

#DrugCompanyPhaseTrials

HRS-7535

SShandong Suncadia Medicine Co., Ltd.

Phase 3

1 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Medrol

Pfizer

Preclinical

1 5

Amidate

Pfizer

Preclinical

1 6

Activase

Zemplar

Adriamycin

Savaysa

Xifaxan

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Heart Failure

NCT06820099

Clinical

Trials by Indication[1]

Type 2 Diabetes3 trials

Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 2·NCT06415214·281 enrolled

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise

Active, not recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT06672172·284 enrolled

A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT06589765·810 enrolled

Efficacy and Safety2 trials

Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 2·NCT06671821·81 enrolled

Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 2·NCT06393348·155 enrolled

Interaction2 trials

Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06727838·54 enrolled

Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human

Not yet recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06495931·24 enrolled

Obesity2 trials

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 3·NCT06904105·556 enrolled

An Open, Fixed-sequence, Self-controlled Pharmacokinetic Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT07269756·40 enrolled

Type 2 Diabetes Mellitus1 trial

A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

Unknown status·SShandong Suncadia Medicine Co., Ltd.·Phase 2·NCT05759897·180 enrolled

6 more indications

Tics1 trial

A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects

Unknown status·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT05347758·106 enrolled

Hepatic Impairment1 trial

Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06961643·24 enrolled

Renal insufficiency1 trial

Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06132204·16 enrolled

Heart Failure1 trial

Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity

Recruiting·SShandong Suncadia Medicine Co., Ltd.·Phase 2·NCT06820099·225 enrolled

Overweight or Obesity1 trial

To Explore the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Multiple Doses of HRS-7535 in Obese Subjects

Completed·SShandong Suncadia Medicine Co., Ltd.·Preclinical·NCT06621316·74 enrolled

Unspecified1 trial

A Clinical Study of Mass Balance of [14C]HRS-7535

Completed·SShandong Suncadia Medicine Co., Ltd.·Phase 1·NCT06819488·6 enrolled

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for HRS-7535. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HRS-7535 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HRS-7535. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shandong Suncadia Medicine 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: SShandong Suncadia Medicine Co., Ltd.

HRS-7535

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Type 2 Diabetes3 trials

Efficacy and Safety2 trials

Interaction2 trials

Obesity2 trials

Type 2 Diabetes Mellitus1 trial

Tics1 trial

Hepatic Impairment1 trial

Renal insufficiency1 trial

Heart Failure1 trial

Overweight or Obesity1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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