Drugs / Difelikefalin
Difelikefalin
also known as
CR845 · MR13A9 · 4-PIPERIDINECARBOXYLIC ACID, N1-(D-PHENYLALANYL-D-PHENYLALANYL-D-LEUCYL-D-LYSYL)-4-AMINO- · Cr-845 acetate · Difelicefalina · DIFELIKEFALIN ACETATE · Difelikefaline · FE-202845 · +2 more
Protein / enzyme biologic targets OPRK1 via activation
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pruritus, hereditary localized 2 milestones | |||||
| Filed | Japan (PMDA) | — | pruritus, hereditary localized | 2022-09-28 | “ジフェリケファリン酢酸塩（一般名）を有効成分とした注射剤（開発番号：MR13A9）」について、丸石製薬が血液透析患者におけるそう痒症の改善を適応症とした日本国内における製造販売承認申請を行いました” kissei.co.jp ↗ |
| Filed | US (FDA) | KORSUVA | pruritus, hereditary localized | 2021-03-08 | “U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVATM (difelikefalin)” csl.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Kapruvia | — | 2022-04-25 | europa.eu ↗ |
| Approved | US (FDA) | KORSUVA | — | 2021-08-23 | fda.gov ↗ |
| Filed | EU (EMA) | — | chronic kidney disease-associated pruritus in hemodialysis patients | 2021-03-30 | “today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection” csl.com ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05885763 | Jun → Oct 2023 | end stage renal failure | Vifor Fresenius Medical Care Renal Pharma | Completed | No outcome recorded |
| Phase 1 | NCT05533008 | Dec 2019 → Jun 2020 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04019574 | Jun → Oct 2019 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03947970 | Jan → Apr 2019 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 27 trials · 3 met primary | ||||||
| Phase 2 | NCT06593392 | Jun 2026 → Aug 2029 expected | chronic kidney disease | Vifor Fresenius Medical Care Renal Pharma | Recruiting | No outcome recorded |
| Phase 2 | NCT03802617 | Feb → Oct 2019 | — | Kissei Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 2 | NCT03617536 | Jul 2018 → Oct 2019 | chronic kidney disease | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02229929 | Jul 2014 → Jul 2015 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01789476 | May → Aug 2013 | — | Cara Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01361568 | Jul 2011 → Apr 2012 | — | Cara Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT00877799 | Mar → Dec 2009 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT02858726 | Jun 2016 → Mar 2017 | — | Cara Therapeutics, Inc. | Completed | Met primary |
| Phase 37 trials · 2 met primary | ||||||
| Phase 3 | NCT05885737 | May 2023 → Sep 2024 | — | Vifor Fresenius Medical Care Renal Pharma | Completed | Met primary |
| Phase 3 | NCT05356403 | Aug 2022 → Feb 2024 | chronic kidney disease | Cara Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05387707 | Aug 2022 → Feb 2024 | atopic eczema | Cara Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05342623 | May 2022 → Feb 2024 | chronic kidney disease | Cara Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04711603 | Jan 2021 → Jan 2022 | — | Kissei Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT03998163 | May 2019 → Feb 2020 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03281538 | Aug 2017 → Feb 2020 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07526324 | Apr 2026 → Jan 2027 expected | end stage renal failure | Chittagong Medical College | Not yet recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05031546 | — | — | Cara Therapeutics, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT04706975 Comparator | Jan 2021 → May 2022 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04018027 Comparator | Jun 2019 → Apr 2021 | atopic eczema | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03995212 Comparator | Jun 2019 → Jun 2022 | cholestasis | Cara Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02944448 Comparator | Sep 2016 → May 2017 | osteoarthritis, hip, osteoarthritis, knee, rheumatic disorder | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02524197 Comparator | Aug 2015 → Jan 2016 | osteoarthritis | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT05978063 Comparator | Aug 2023 → Apr 2024 | — | Cara Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2/3 | NCT02542384 Comparator | Sep 2015 → Apr 2018 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03636269 Comparator | Jul 2018 → Mar 2020 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03422653 Comparator | Feb 2018 → Apr 2019 | — | Cara Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2023-10-23 | Maruishi Pharmaceutical | Results 静注透析そう痒症改善剤「コルスバ®静注透析用シリンジ」の国内第Ⅲ相臨床試験結果がNEJM Evidenceに掲載 maruishi-pharm.co.jp ↗ |
| 2023-10-23 | Kissei Pharmaceutical Co., Ltd. | Results 静注透析そう痒症改善剤「コルスバ®静注透析用シリンジ」の国内第Ⅲ相臨床試験結果がNEJM Evidenceに掲載 kissei.co.jp ↗
二重盲検期において、本剤またはプラセボのいずれかを6週間投与した結果、主要評価項目である「4週時の平均かゆみNRSスコアのベースラインからの変化量」は、本剤投与群 -2.06、プラセボ投与群 -1.09であり、プラセボ投与群に対して本剤投与群の優越性が示されました（p<0.001）。 |
| 2023-09-25 | Maruishi Pharmaceutical | Regulatory 静注透析そう痒症改善剤「コルスバ®静注透析用シリンジ17.5μg、同25.0μg、同35.0μg」の国内製造販売承認取得のお知らせ maruishi-pharm.co.jp ↗ |
| 2023-09-25 | Kissei Pharmaceutical Co., Ltd. | Regulatory 静注透析そう痒症改善剤「コルスバ®静注透析用シリンジ17.5μg、同25.0μg、同35.0μg」の国内製造販売承認取得のお知らせ kissei.co.jp ↗
丸石製薬が血液透析患者におけるそう痒症の改善（既存治療で効果不十分な場合に限る）を適応症として、厚生労働省より製造販売承認を取得しましたので、お知らせします。 |
| 2022-09-28 | Maruishi Pharmaceutical | Regulatory 透析患者におけるそう痒症治療薬「ジフェリケファリン酢酸塩」の国内製造販売承認申請のお知らせ maruishi-pharm.co.jp ↗ |
| 2022-09-28 | Kissei Pharmaceutical Co., Ltd. | Regulatory 透析患者におけるそう痒症治療薬「ジフェリケファリン酢酸塩」の国内製造販売承認申請のお知らせ kissei.co.jp ↗ |
| 2022-01-07 | Kissei Pharmaceutical Co., Ltd. | Results 透析患者におけるそう痒症治療薬「ジフェリケファリン（MR13A9）」の 国内第Ⅲ相臨床試験の結果（二重盲検期）について ―主要評価項目を達成― kissei.co.jp ↗
今般、二重盲検期が終了し、ジフェリケファリン群はプラセボ群に対して主要評価項目である「かゆみに対するNRSスコア変化量」および副次評価項目である「白取の重症度基準スコア変化量」を統計学的に有意に改善しました。 |
| 2021-08-24 | CSL Behring | Regulatory Vifor Pharma and Cara Therapeutics announce U.S. FDA approval of KORSUVA™ injection for the treatment of moderate to severe pruritus in hemodialysis patients csl.com ↗
Vifor Pharma and Cara Therapeutics (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. |
| 2021-03-30 | CSL Behring | Regulatory Vfmcrp and Cara Therapeutics Announce European Medicines Agency Has Accepted to Review the Marketing Authorization Application for Difelikefalin csl.com ↗
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. |
| 2021-03-08 | CSL Behring | Regulatory Vifor Pharma and Cara Therapeutics Announce U.s. Fda Acceptance and Priority Review of Nda for Korsuva™* Injection in Hemodialysis Patients With Moderate-to-severe Pruritus csl.com ↗ |
| 2020-04-21 | CSL Behring | Results Vifor Pharma Press Release Phase-iii Kalm-2 Trial of Korsuva csl.com ↗
today announced positive topline data from Cara’s KALM-2 pivotal phase-III trial of KORSUVATM (CR845/difelikefalin) Injection in haemodialysis patients with moderate-to-severe chronic kidney diseaseassociated pruritus (CKD-aP). |
All press releases naming this drug 20 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 32 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | difelikefalin | “INTERVENTION: At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.” PMID 36039153 ↗ Jun 2022 |
| Known as | 4-PIPERIDINECARBOXYLIC ACID, N1-(D-PHENYLALANYL-D-PHENYLALANYL-D-LEUCYL-D-LYSYL)-4-AMINO- | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | Cr-845 acetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | CR845 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04019574 ↗ |
| Known as | Difelicefalina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | DIFELIKEFALIN ACETATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | Difelikefaline | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | FE-202845 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | Kapruvia | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | Korsuva | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989915 ↗ |
| Known as | MR13A9 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03802617 ↗ |
| Action | Activate | “Because CR845 activates kappa receptors instead of mu receptors, the side effects are different than with a morphine-type drug.” NCT00877799 ↗1“Kappa opioid receptor agonist” CHEMBL3989915 ↗ |
| Modality | Peptide | “Its hydrophilic peptide structure limits its ability to cross the blood-brain barrier, thereby reducing central nervous system effects.” NCT07526324 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL3989915 ↗ |
| Route | Intravenous | “single intravenous doses of the kappa opioid agonist CR845” NCT00877799 ↗ |
| Target | OPRK1 | “Kappa opioid receptor agonist” CHEMBL3989915 ↗ |