Research statistics

Difelikefalin research: publications and trials

What has been published on Difelikefalin: PubMed publications, the kind of evidence they report and registered clinical trials. These are counts of research, not a judgment of whether Difelikefalin works or is safe. For what it is and what the studies found, see the Difelikefalin profile.

Automated weekly refresh · data through November 1, 2026

At a glance

Publications, all years

101

Since 2019

Publications in 2026 so far

Through November 1, 2026

Human clinical research

39.4%

39 of 99 classified

Registered clinical trials

ClinicalTrials.gov

Randomized controlled trials

Publications reporting an RCT in people

Systematic reviews and meta-analyses

Preclinical studies

15.2%

9 animal · 0 in vitro · 6 computational

Records that only mention it

Not counted above

Status in the library: FDA-approved. 2 publications are not yet classified by study type.

What to keep in mind

Some completed trials have neither posted results nor a linked results publication.

Publications by year

Difelikefalin publications by year and evidence

Counted PubMed publications by year of first publication. * 2026 runs to November 1, 2026. A larger bar is more publications, not stronger evidence.

Show the data

Year	Human clinical research	Preclinical (animal, in vitro, computational)	Reviews and meta-analyses	Other and not yet classified	Total
2019	1	0	0	0	1
2020	2	0	2	6	10
2021	2	0	1	0	3
2022	4	1	4	3	12
2023	6	2	5	1	14
2024	8	2	10	3	23
2025	10	4	5	2	21
2026 (to date)	6	6	3	2	17

Study types

Review	22
Randomized controlled trial	17
Editorial, letter or other	13
Observational human study	10
Animal study	9
Other clinical trial	7
Computational study	6
Case report	5
Meta-analysis	5
Systematic review	3
Not yet classified	2
Guideline or consensus	1
Correction or retraction notice	1

Research areas

From MeSH major topics. A paper can be in several areas.

Dermatology	70
Reproductive and sexual health	29
Gastrointestinal	21
Neurological and mental health	18
Immune system	10
Endocrinology	7
Tissue repair	5
Metabolic health	3
Antimicrobial and infectious disease	2
Cardiovascular	2

Registered clinical trials

5 of 20 trials completed at least a year before the cutoff have neither posted results nor a linked results publication. A registration is not a result.

Completed: 20 · Terminated: 5 · Approved for marketing: 1 · Not yet recruiting: 1 · Recruiting: 1
Phase not applicable: 2 · Phase 1: 4 · Phase 2: 11 · Phase 2 / Phase 3: 3 · Phase 3: 8

Trial	Status	Phase	Started	Results
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe PruritusNCT06593392 · 18 enrolled	Recruiting	Phase 2	2026-08	—
Difelikefalin for Itching in Hemodialysis Patients With Chronic Kidney DiseaseNCT07526324 · 106 enrolled	Not yet recruiting	Phase not applicable	2026-04	—
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia ParestheticaNCT05978063 · 214 enrolled	Terminated	Phase 2, Phase 3	2023-08	—
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on HaemodialysisNCT05885763 · 30 enrolled	Completed	Phase 1	2023-06	Posted
Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe PruritusNCT05885737 · 260 enrolled	Completed	Phase 3	2023-05	Posted
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe PruritusNCT05356403 · 105 enrolled	Terminated	Phase 3	2022-08	—
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 DermatitisNCT05387707 · 287 enrolled	Terminated	Phase 3	2022-08	—
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe PruritusNCT05342623 · 286 enrolled	Terminated	Phase 3	2022-05	—
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)NCT04706975 · 126 enrolled	Completed	Phase 2	2021-01	—
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis PatientsNCT05533008 · 35 enrolled	Completed	Phase 1	2019-12	—
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic DermatitisNCT04018027 · 401 enrolled	Completed	Phase 2	2019-06	—
Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe PruritusNCT03995212 · 14 enrolled	Terminated	Phase 2	2019-06	—
Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy SubjectsNCT04019574 · 57 enrolled	Completed	Phase 1	2019-06	—
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe PruritusNCT03998163 · 222 enrolled	Completed	Phase 3	2019-05	Posted
Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy SubjectsNCT03947970 · 12 enrolled	Completed	Phase 1	2019-01	—
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe PruritusNCT03636269 · 473 enrolled	Completed	Phase 3	2018-07	Posted
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe PruritusNCT03617536 · 269 enrolled	Completed	Phase 2	2018-07	Posted
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)NCT03422653 · 378 enrolled	Completed	Phase 3	2018-02	Posted
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe PruritusNCT03281538 · 288 enrolled	Completed	Phase 3	2017-08	Posted
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or KneeNCT02944448 · 761 enrolled	Completed	Phase 2	2016-09	Posted
Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe PruritusNCT02858726 · 226 enrolled	Completed	Phase 2, Phase 3	2016-06	Posted
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal SurgeryNCT02542384 · 451 enrolled	Completed	Phase 2, Phase 3	2015-09	—
A Study of the Safety and Effectiveness of Orally Administered CR845 in Patients With Osteoarthritis of the Hip or KneeNCT02524197 · 81 enrolled	Completed	Phase 2	2015-08	—
Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic PruritusNCT02229929 · 89 enrolled	Completed	Phase 2	2014-07	—
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy SurgeryNCT01789476 · 51 enrolled	Completed	Phase 2	2013-05	Posted
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy SurgeryNCT01361568 · 203 enrolled	Completed	Phase 2	2011-07	Posted
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy SurgeryNCT00877799 · 114 enrolled	Completed	Phase 2	2009-03	Posted
Intermediate-Size Patient Population Expanded Access Program for Intravenous DifelikefalinNCT05031546	Approved for marketing	Phase not applicable	—	—

Human trials and evidence reviews

Meta-analyses, systematic reviews and trials in people, newest first.

The Efficacy and Safety of Intravenous Difelikefalin for the Treatment of Pruritus in Patients Undergoing Hemodialysis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Blood purification · January 2, 2026 · Meta-analysis · cited 0 times
PMID 41481512 · DOI 10.1159/000549805 · Reviews and meta-analyses
Meta-Analysis of Randomized Controlled Trials on Gamma-Aminobutyric Acid Analogues and Opioid-Based Therapies for CKD-Associated Pruritus.
Kidney international reports · June 24, 2025 · Meta-analysis · cited 3 times · open access
PMID 40980656 · DOI 10.1016/j.ekir.2025.06.037 · Reviews and meta-analyses
The efficacy and safety of kappa opioid receptor (KOR) agonists in patients with uraemic pruritus: a systematic review and network meta-analysis.
Clinical kidney journal · June 23, 2025 · Meta-analysis · cited 2 times · open access
PMID 40567495 · DOI 10.1093/ckj/sfaf131 · Reviews and meta-analyses
The efficacy and safety of difelikefalin for pruritus in hemodialysis patients: a systematic review and meta-analysis of randomized controlled trials.
Renal failure · August 1, 2024 · Meta-analysis · cited 7 times · open access
PMID 39091079 · DOI 10.1080/0886022x.2024.2384590 · Reviews and meta-analyses
Efficacy and safety of difelikefalin in the treatment of hemodialysis patients with pruritus: A meta-analysis and systematic review.
Clinical nephrology · April 1, 2024 · Meta-analysis · cited 7 times
PMID 38294219 · DOI 10.5414/cn111169 · Reviews and meta-analyses
Real-world effectiveness and safety of difelikefalin for chronic kidney disease-associated pruritus: a systematic review.
Renal failure · July 1, 2026 · Systematic review · cited 0 times · open access
PMID 42576770 · DOI 10.1080/0886022x.2026.2711185 · Reviews and meta-analyses
Association of pruritus with comorbidities and survival in chronic kidney disease: a narrative review of the pre-difelikefalin era literature.
Renal failure · February 18, 2026 · Systematic review · cited 2 times · open access
PMID 41708519 · DOI 10.1080/0886022x.2026.2622801 · Reviews and meta-analyses
Difelikefalin in the treatment of hemodialysis patients with pruritus: a systematic review and meta-analysis.
Frontiers in pharmacology · December 6, 2024 · Systematic review · cited 6 times · open access
PMID 39712488 · DOI 10.3389/fphar.2024.1476587 · Reviews and meta-analyses
Difelikefalin in Chinese patients with chronic kidney disease-associated pruritus.
Clinical kidney journal · February 6, 2026 · Randomized controlled trial · cited 2 times · open access
PMID 41948117 · DOI 10.1093/ckj/sfag031 · Human clinical research
Systemic Inflammatory Markers Correlate with Chronic Kidney Disease-Associated Pruritus and Response to Treatment.
The Journal of investigative dermatology · May 21, 2025 · Randomized controlled trial · cited 8 times · open access
PMID 40409676 · DOI 10.1016/j.jid.2025.04.035 · Human clinical research

Most cited

By OpenAlex citation count. Citations measure attention, not quality or correctness.

A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus.
The New England journal of medicine · November 8, 2019 · Randomized controlled trial · cited 383 times
PMID 31702883 · DOI 10.1056/nejmoa1912770 · Human clinical research
Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies.
Kidney medicine · June 28, 2022 · Randomized controlled trial · cited 103 times · open access
PMID 36016762 · DOI 10.1016/j.xkme.2022.100512 · Human clinical research
Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.
Kidney international reports · January 28, 2020 · Randomized controlled trial · cited 90 times · open access
PMID 32405581 · DOI 10.1016/j.ekir.2020.01.006 · Human clinical research
Difelikefalin: First Approval.
Drugs · November 1, 2021 · Review · cited 68 times
PMID 34674115 · DOI 10.1007/s40265-021-01619-6 · Reviews and meta-analyses
Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program.
Kidney medicine · June 28, 2022 · Randomized controlled trial · cited 51 times · open access
PMID 36039153 · DOI 10.1016/j.xkme.2022.100513 · Human clinical research

Latest publications

The pharmacokinetics of a single intravenous dose of difelikefalin in adolescents aged 12 to 17 years on hemodialysis.
Pediatric nephrology (Berlin, Germany) · October 19, 2026 · Other clinical trial · cited 0 times · open access
PMID 42895571 · DOI 10.1007/s00467-026-07561-7 · Human clinical research
Efficacy and Safety of Switching from Nalfurafine to Difelikefalin in Hemodialysis Patients with Refractory Pruritus.
Journal of personalized medicine · September 23, 2026 · Observational human study · cited 0 times
PMID 42930764 · DOI 10.3390/jpm16100489 · Human clinical research
Difelikefalin Treatment in Chronic Kidney Disease-Associated Pruritus: Modelling Infection-Related Hospitalisation Cost Offsets Using Trial and Real-World Data Across Seven European Countries.
Advances in therapy · August 10, 2026 · Computational study · cited 0 times · open access
PMID 42573951 · DOI 10.1007/s12325-026-03735-9 · Computational studies
Difelikefalin in gabapentinoid-refractory CKD-associated pruritus: real-world experience from Australia.
Journal of nephrology · July 1, 2026 · Observational human study · cited 0 times · open access
PMID 42228030 · DOI 10.1093/joneph/aajaf077 · Human clinical research
Real-world effectiveness and safety of difelikefalin for chronic kidney disease-associated pruritus: a systematic review.
Renal failure · July 1, 2026 · Systematic review · cited 0 times · open access
PMID 42576770 · DOI 10.1080/0886022x.2026.2711185 · Reviews and meta-analyses
Difelikefalin-associated adverse drug event signals: a real-world pharmacovigilance study from the FAERS database.
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · June 22, 2026 · Observational human study · cited 0 times
PMID 42329786 · DOI 10.1093/ndt/gfag144 · Human clinical research
JAAD Game Changer: A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus.
Journal of the American Academy of Dermatology · June 15, 2026 · Editorial, letter or other · cited 0 times · open access
PMID 42297298 · DOI 10.1016/j.jaad.2026.06.040 · Commentary and other
Development of a SMEDDS for oral delivery of hydrophilic peptide difelikefalin acetate: Preparation, characterization, and PK/PD evaluation.
Journal of pharmaceutical sciences · June 6, 2026 · Animal study · cited 0 times
PMID 42250802 · DOI 10.1016/j.xphs.2026.104356 · Animal studies
Innovative Microneedle Patches for Psoriasis Treatment: A Dual Approach With Methotrexate-Zinc and Difelikefalin for Enhanced Therapeutic Outcomes.
Small (Weinheim an der Bergstrasse, Germany) · May 30, 2026 · Animal study · cited 1 times · open access
PMID 42216778 · DOI 10.1002/smll.73958 · Animal studies
Real-world effectiveness of difelikefalin for CKD-aP in UK haemodialysis: a single-centre experience.
Clinical kidney journal · April 29, 2026 · Editorial, letter or other · cited 0 times · open access
PMID 42137550 · DOI 10.1093/ckj/sfag129 · Commentary and other

Browse all 101 publications in the dashboard

How this is counted

PubMed records matched by the names below, counted when the peptide is in the title, indexed by MeSH, or confirmed from the abstract. The exact query can be rerun on Europe PMC. Methodology

Search terms: CR845; Difelikefalin; FE 202845; Kapruvia; Korsuva

((TITLE_ABS:"CR845" OR CHEM:"CR845" OR TITLE_ABS:"CR 845" OR CHEM:"CR 845") OR (TITLE_ABS:"Difelikefalin" OR CHEM:"Difelikefalin") OR (TITLE_ABS:"FE 202845" OR CHEM:"FE 202845" OR TITLE_ABS:"FE202845" OR CHEM:"FE202845") OR (TITLE_ABS:"Kapruvia" OR CHEM:"Kapruvia") OR (TITLE_ABS:"Korsuva" OR CHEM:"Korsuva")) AND SRC:MED

Cite this page

Peptide Library. (2026, November 2). Difelikefalin research statistics (Version weekly-2026-11-01) [Statistic]. Peptide Library. https://peptidelibrary.app/research/peptides/difelikefalin