Key Highlights

Risk & Performance

Pipeline Risk Assessment

Based on historical performance

Moderate Risk

Score: 55/100

Failure Rate

20.8%

5 terminated/withdrawn out of 24 trials

Success Rate

78.3%

-8.2% vs industry average

Late-Stage Pipeline

29%

7 trials in Phase 3/4

Results Transparency

56%

10 of 18 completed trials have results

Key Signals

10 with results

Enrollment Performance

Analytics

Phase 2

13(56.5%)

Phase 3

7(30.4%)

Phase 1

3(13.0%)

23Total

Phase 2(13)

Phase 3(7)

Phase 1(3)

Activity Timeline

Global Presence

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Clinical Trials (24)

Showing 20 of 24 trials

NCT05978063Phase 2Terminated

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

Role: lead

NCT05342623Phase 3Terminated

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

Role: lead

NCT05356403Phase 3Terminated

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

Role: lead

NCT05387707Phase 3Terminated

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

Role: lead

NCT03617536Phase 2Completed

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

Role: lead

NCT03995212Phase 2Terminated

Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

Role: lead

NCT04706975Phase 2Completed

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

Role: lead

NCT05533008Phase 1Completed

CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

Role: lead

NCT05031546Unknown

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Role: lead

NCT03422653Phase 3Completed

A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)

Role: lead

NCT03636269Phase 3Completed

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Role: lead

NCT04018027Phase 2Completed

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

Role: lead

NCT03998163Phase 3Completed

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Role: lead

NCT03281538Phase 3Completed

Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Role: lead

NCT02944448Phase 2Completed

A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee

Role: lead

NCT02858726Phase 2Completed

Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Role: lead

NCT04019574Phase 1Completed

Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects

Role: lead

NCT03947970Phase 1Completed

Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects

Role: lead

NCT02542384Phase 2Completed

A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery

Role: lead

NCT02524197Phase 2Completed

A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or Knee

Role: lead