kappa opioid receptor agonist

Difelikefalin updates

Name: Difelikefalin updates
Creator: Global Peptide Index
License: https://globalpeptideindex.com/methodology

Answer

1 change for Difelikefalin in the last 12 months. Latest: 2026-04-13.

Date	Type	What changed	Source
2026-04-13	Trial	New trial registered: Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney Disease	Trial register ClinicalTrials.gov
2025-09-12	Results	Results posted: Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2025-08-26	Label	FDA label revised: Korsuva (NDA214916)	Regulator FDA drug label register
2025-02-14	Results	Results posted: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis	Trial register ClinicalTrials.gov
2024-09-19	Trial	New trial registered: Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2024-01-24	Results	Results posted: A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2023-11-28	Federal Register	Federal Register notice: Determination of Regulatory Review Period for Purposes of Patent Extension; Korsuva	Regulator Federal Register
2023-08-07	Trial	New trial registered: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica	Trial register ClinicalTrials.gov
2023-06-02	Trial	New trial registered: Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2023-06-02	Trial	New trial registered: Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis	Trial register ClinicalTrials.gov
2023-05-19	Federal Register	Federal Register notice: Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability	Regulator Federal Register
2022-09-08	Trial	New trial registered: CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients	Trial register ClinicalTrials.gov
2022-05-24	Trial	New trial registered: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Su	Trial register ClinicalTrials.gov
2022-05-02	Trial	New trial registered: CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruri	Trial register ClinicalTrials.gov
2022-04-26	Results	Results posted: A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)	Trial register ClinicalTrials.gov
2022-04-26	Results	Results posted: CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2022-04-22	Trial	New trial registered: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2021-10-15	Results	Results posted: CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2021-10-14	Results	Results posted: Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2021-09-02	Trial	New trial registered: Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin	Trial register ClinicalTrials.gov
2021-01-13	Trial	New trial registered: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMF	Trial register ClinicalTrials.gov
2020-10-20	Results	Results posted: A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee	Trial register ClinicalTrials.gov
2020-07-29	Results	Results posted: Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2019-07-15	Trial	New trial registered: Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects	Trial register ClinicalTrials.gov
2019-07-12	Trial	New trial registered: Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis	Trial register ClinicalTrials.gov
2019-06-21	Trial	New trial registered: Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pr	Trial register ClinicalTrials.gov
2019-05-13	Trial	New trial registered: Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in	Trial register ClinicalTrials.gov
2019-05-07	Trial	New trial registered: CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2018-08-03	Trial	New trial registered: CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2018-07-11	Trial	New trial registered: A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2018-01-25	Trial	New trial registered: A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)	Trial register ClinicalTrials.gov
2017-06-20	Trial	New trial registered: Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2016-10-04	Trial	New trial registered: A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee	Trial register ClinicalTrials.gov
2016-07-29	Trial	New trial registered: Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus	Trial register ClinicalTrials.gov
2015-09-03	Trial	New trial registered: A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery	Trial register ClinicalTrials.gov

From ClinicalTrials.gov, EU CTIS, FDA labels, recalls, shortages and warning letters, the Federal Register, and regulators' published actions. Not medical advice.

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