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Korsuva

(Difelikefalin)

Phase 3Small molecule

VVifor (International) Inc.

1

Indications

10

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

12

Patents

Timeline

Expected Milestones

Q3 2029

Phase 2Recruiting

Pruritus

NCT06593392

Clinical

Trials by Indication[1]

Pruritus4 trials

Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Completed·VVifor Fresenius Medical Care Renal Pharma·Phase 3·NCT05885737·260 enrolled

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

Terminated·CCara Therapeutics, Inc.·Phase 2/3·NCT05978063·214 enrolled

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

Completed·CCara Therapeutics, Inc.·Phase 2·NCT04706975·126 enrolled

Show 1 more trial

KOR-PED-202 An Open-label, Single-arm Study to Evaluate the Safety and Tolerability of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis With Moderate-to-Severe Pruritus

Recruiting·VVifor Fresenius Medical Care Renal Pharma·Phase 2·NCT06593392·18 enrolled

Chronic Kidney Disease2 trials

CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Terminated·CCara Therapeutics, Inc.·Phase 3·NCT05356403·105 enrolled

A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Terminated·CCara Therapeutics, Inc.·Phase 3·NCT05342623·286 enrolled

Atopic Dermatitis2 trials

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Completed·CCara Therapeutics, Inc.·Phase 2·NCT04018027·401 enrolled

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Terminated·CCara Therapeutics, Inc.·Phase 3·NCT05387707·287 enrolled

Haemodialysis1 trial

Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

Completed·VVifor Fresenius Medical Care Renal Pharma·Phase 1·NCT05885763·30 enrolled

Intravenous1 trial

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Approved for marketing·CCara Therapeutics, Inc.··NCT05031546

Regulatory

FDA Approval Timeline[4]

Aug 23, 2021

KORSUVA

NDA NDA214916

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Difelikefalin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Difelikefalin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Difelikefalin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214916). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Korsuva. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vifor (International) Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: VVifor (International) Inc.

Patent Landscape[5]

Patent Cliff

Nov 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10793596Nov 12, 2027

10138270Nov 12, 2027

10017536Nov 12, 2027

9359399Nov 12, 2027

9334305Nov 12, 2027

7 more patents

8536131Nov 12, 2027

8486894Nov 12, 2027

8236766Nov 12, 2027

8217007Nov 12, 2027

7727963Nov 12, 2027

7713937Nov 12, 2027

7402564Nov 12, 2027

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