nalfurafine hydrochloride

Phase 3Small molecule

SShandong New Time Pharmaceutical Co., LTD

nalfurafine hydrochloride is one of 54 small molecule programs targeting Humans. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HumansCompleted

Chronic Kidney DiseaseNot yet recruiting

HumansPreclinical

Completed

Chronic Kidney DiseasePhase 3

Not yet recruiting

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

nalfurafine hydrochloride

SShandong New Time Pharmaceutical Co., LTD

Phase 3

1 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

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

Timeline

Expected Milestones

Q4 2026

ApprovedNot yet recruiting

Chronic Kidney Disease

NCT07769073

Clinical

Trials by Indication[1]

Pruritus2 trials

Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis

Completed·SSK Chemicals Co., Ltd.·Phase 3·NCT01513161·104 enrolled

Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

Terminated·TToray Industries, Inc·Phase 2·NCT01660243·45 enrolled

Liver Disease1 trial

Phase II Study of TRK-820 Soft Capsules - Intractable Pruritus in Patients With Chronic Liver Disease -

Completed·TToray Industries, Inc·Phase 2·NCT00638495·120 enrolled

Humans1 trial

Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans

Completed·SShandong New Time Pharmaceutical Co., LTD·N/A·NCT07478133·72 enrolled

Hemodialysis1 trial

Safety Study of TRK-820 for Patient With Hemodialysis

Completed·SSK Chemicals Co., Ltd.·Phase 1·NCT01248650·16 enrolled

Oral1 trial

A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet

Unknown status·SShenyang Sunshine Pharmaceutical Co., LTD.·Phase 3·NCT04728984·135 enrolled

1 more indication

Chronic Kidney Disease1 trial

Efficacy of Nalfurafine for Chronic Kidney Disease-Associated Pruritus in Twice-Weekly Hemodialysis Patients: A Randomized Controlled Trial

Not yet recruiting·IIndonesia University·Approved·NCT07769073·36 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for nalfurafine hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — nalfurafine hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for nalfurafine hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Shandong New Time 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: SShandong New Time Pharmaceutical Co., LTD

nalfurafine hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Pruritus2 trials

Liver Disease1 trial

Humans1 trial

Hemodialysis1 trial

Oral1 trial

Chronic Kidney Disease1 trial

References

Drug Info

Quick Facts

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