HRS-5965

Phase 3Small molecule

HRS-5965 is one of 44 small molecule programs targeting Paroxysmal Nocturnal Hemoglobinuria. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Paroxysmal Nocturnal HemoglobinuriaCompleted

Iga NephropathyRecruiting

Paroxysmal Nocturnal HemoglobinuriaPhase 3

Completed

Iga NephropathyPhase 3

Recruiting

Competition

Competitive Landscape

43 competitors in Iga Nephropathy

#DrugCompanyPhaseTrials

Cellcept

Roche

Approved

7 2

Rituxan

Roche

Approved

2 3

Lorelco

Sanofi

Approved

1 4

Fabhalta

Novartis

Approved

—5

Velcade

SShilpa Grover, MD, MPH

Approved

1 6

Tekturna

Tibotec Pharmaceuticals, Ireland

Approved

1 7

Kerendia

Bayer

Phase 3

2 8

Farxiga

AstraZeneca

Phase 3

1 9

Filspari

TTravere Therapeutics, Inc.

Phase 3

2 10

Vanrafia

Novartis

Phase 3

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

Timeline

Expected Milestones

Q4 2027

Phase 2Active, not recruiting

Paroxysmal Nocturnal Hemoglobinuria

NCT06238544

Q4 2028

Phase 3Recruiting

Iga Nephropathy

NCT07014826

Clinical

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria3 trials

A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 3·NCT06593938·76 enrolled

Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Active, not recruiting·CChengdu Suncadia Medicine Co., Ltd.·Phase 2·NCT06238544·132 enrolled

Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 2·NCT06051357·26 enrolled

Renal insufficiency1 trial

Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT05505955·83 enrolled

Interaction1 trial

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT07040787·36 enrolled

Adult1 trial

A Study to Evaluate the Mass Balance of [14C] HRS-5965 in Healthy Adult Male Volunteers

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT06567392·6 enrolled

Hepatic Impairment1 trial

Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT06674915·24 enrolled

5 more indications

Anemia1 trial

Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 3·NCT06715943·39 enrolled

MPA1 trial

Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT06490991·16 enrolled

IgA Nephropathy1 trial

A Trial of HRS-5965 Capsule in Primary IgA Nephropathy

Recruiting·CChengdu Suncadia Medicine Co., Ltd.·Phase 3·NCT07014826·378 enrolled

Primary IgA Nephropathy1 trial

A Trial to Evaluate the Efficacy and Safety of HRS-5965 Tablets in Primary IgA Nephropathy

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 2·NCT06137768·123 enrolled

Unspecified2 trials

A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT07035665·16 enrolled

A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects

Completed·CChengdu Suncadia Medicine Co., Ltd.·Phase 1·NCT06684041·32 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for HRS-5965. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HRS-5965 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HRS-5965. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Chengdu 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: CChengdu Suncadia Medicine Co., Ltd.

HRS-5965

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q4 2028

Trials by Indication[1]

Paroxysmal Nocturnal Hemoglobinuria3 trials

Renal insufficiency1 trial

Interaction1 trial

Adult1 trial

Hepatic Impairment1 trial

Anemia1 trial

MPA1 trial

IgA Nephropathy1 trial

Primary IgA Nephropathy1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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