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  1. pharmadog
  2. ›drugs
  3. ›Korsuva
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difelikefalin

Marketedupdated 5mo ago
by Vifor Pharma Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • tagNephrology2 co-mentions · 1 sources
  • companyChittagong Medical College1 co-mentions · 1 sources
  • tagDermatology1 co-mentions · 1 sources

all catalysts(1)

phase 2 initiation · 1
Apr 26, 2026
phase 2 initiation
5mo ago
Chittagong Medical College — difelikefalin (Phase II Trial Initiation)
difelikefalin
→

Trials studying difelikefalin

  • phase2Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritusrecruitingn=18
  • phase3Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Prurituscompletedn=260
  • phase1Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysiscompletedn=30
  • phase3Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Parestheticaterminatedn=214
  • phase3CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritusterminatedn=105
  • phase3A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritusterminatedn=286
  • phase3Study 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 Dermatitisterminatedn=287
  • phase2Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)completedn=126

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 12, 2027
~1.1 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (12)

  • Nov 12, 2027compositionUS 100175361.1y
  • Nov 12, 2027method-of-use (U-3204)US 101382701.1y
  • Nov 12, 2027compositionUS 107935961.1y
  • Nov 12, 2027compositionUS 74025641.1y
  • Nov 12, 2027compositionUS 77139371.1y
  • Nov 12, 2027compositionUS 77279631.1y
  • Nov 12, 2027method-of-use (U-3204)US 82170071.1y
  • Nov 12, 2027method-of-use (U-3204)US 82367661.1y
  • Nov 12, 2027method-of-use (U-3204)US 84868941.1y
  • Nov 12, 2027compositionUS 85361311.1y
  • Nov 12, 2027method-of-use (U-3204)US 93343051.1y
  • Nov 12, 2027method-of-use (U-3204)US 93593991.1y

FDA exclusivities (1)

  • Aug 23, 2026NCENew Chemical Entity (5y)

News(1)

  • CSL pays $355M to co-develop Alentis’ phase 2-stage fibrosis drug
    Australia’s CSL is paying $355 million upfront for the rights to Alentis Therapeutics’ phase 2-stage fibrosis drug.
    fiercebiotech · 1d ago
brand
Korsuva
generic
difelikefalin
indication
Uremic (Renal) Pruritus
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 2h ago
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