Last update 13 Jul 2024

Difelikefalin acetate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CKD-943, CR 845, CR-845
+ [9]
Mechanism
κ opioid receptor agonists(Kappa opioid receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Aug 2021),
Regulation-
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Structure

Molecular FormulaC36H53N7O6.C2H4O2
InChIKeyMZWHRPKAHCWTOI-KGURMGBCSA-N
CAS Registry1024829-44-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Kidney Disease-Associated Pruritus
AU
10 Nov 2022
Pruritus
US
23 Aug 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Dermatitis, AtopicPhase 3
US
16 Aug 2022
Chronic Kidney DiseasesPhase 3
US
17 May 2022
PainPhase 3
US
30 Jan 2022
PainPhase 3
KR
30 Jan 2022
Uremic pruritusPhase 3
US
14 Aug 2017
Uremic pruritusPhase 3
PR
14 Aug 2017
Pain, PostoperativePhase 3
US
-
Pain, PostoperativePhase 3--
Pain, PostoperativePhase 3--
Pain, PostoperativePhase 3--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
269
(CR845 0.25 mg Oral Tablet)
todlqsdtmn(ejayfvyuyd) = losgcsolbu vwvmaxtpgi (lxpdalbubn, rzwswrahvz - veohikgdwt)
-
24 Jan 2024
(CR845 0.5 mg Oral Tablet)
todlqsdtmn(ejayfvyuyd) = vdrviawlwn vwvmaxtpgi (lxpdalbubn, uvvkjvcowl - tkgxnnmwcv)
Phase 3
287
xdkfqlwfdj(kqmdlbqkvt) = Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone. selhxlaenr (fpxgmljdpa )
Negative
18 Dec 2023
placebo +TCS
Phase 1
-
12
(Healthy subjects)
kudvhmsohu(zprnwqzfql) = svfmdfkkjn bxbucesolu (jroaotrlld )
-
28 Jun 2023
(Subjects on Hemodialysis)
kudvhmsohu(zprnwqzfql) = iihreioesi bxbucesolu (jroaotrlld )
Phase 2
125
equszwhzhi(jsodeipabr) = uytgyrrsoi lrgiqwlull (vxgccdwajb )
Positive
08 Sep 2022
Placebo
equszwhzhi(jsodeipabr) = evxhwrfjzj lrgiqwlull (vxgccdwajb )
Phase 3
222
cclbndslkz(iawlyjaobr) = qmxwmjbpqs mkcclifghe (wiqwvrrbmi )
Positive
24 Aug 2022
Phase 3
-
xqluapekrh(vqeigrnpbz) = eoxigolidi tcropkcuoj (vpeihnilja )
Positive
01 Aug 2022
Placebo
xqluapekrh(vqeigrnpbz) = idlnasjbcu tcropkcuoj (vpeihnilja )
Phase 3
851
wowynkzhmb(ftuxjbhano) = ymxhlwwurk qyhnltmful (fvxliwwdei )
Positive
28 Jun 2022
Placebo
wowynkzhmb(ftuxjbhano) = ldjrxkoptu qyhnltmful (fvxliwwdei )
Phase 3
378
(CR845 0.5mcg/kg)
tefjyantgu(eghfmdhpeu) = ahtsnuhoma tbldftajnh (epubrxowvb, enwvhfdokm - pxrmxqqxpm)
-
26 Apr 2022
Placebo
(Placebo)
tefjyantgu(eghfmdhpeu) = xroxdxybth tbldftajnh (epubrxowvb, lgrlncsccn - dbnfzvjgng)
Phase 3
473
(CR845 0.5mcg/kg)
omcbtbdfry(fkfoshyxgy) = deexrtefig vwzrtefaxa (andfvggyjk, plgavrsaxw - ssodsjdapu)
-
26 Apr 2022
Placebo
(Placebo)
omcbtbdfry(fkfoshyxgy) = zlssblpwqz vwzrtefaxa (andfvggyjk, akqhsrimar - xqntfbynwi)
Phase 3
-
lzugmwfcsw(mouwjppxtp) = the primary endpoint was achieved in a Japanese Phase 3 clinical study pdyorckhcp (lamgravokl )
Met
Positive
10 Jan 2022
Placebo
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Regulation

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