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    Chemistry

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    Also known as: Cr845 acetate, Cr-845 acetate, 1024829-44-4, Unii-0p70ar5byb, 0p70ar5byb, Korsuva
    Molecular Formula
    C38H57N7O8
    Molecular Weight
    739.9  g/mol
    InChI Key
    MZWHRPKAHCWTOI-KGURMGBCSA-N
    FDA UNII
    0P70AR5BYB
    Difelikefalin Acetate
    DIFELIKEFALIN ACETATE is a Protein drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2021 and is indicated for chronic kidney disease and pruritus.
    1 2D Structure

    Difelikefalin Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    acetic acid;4-amino-1-[(2R)-6-amino-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid
    2.1.2 InChI
    InChI=1S/C36H53N7O6.C2H4O2/c1-24(2)21-29(32(45)40-28(15-9-10-18-37)34(47)43-19-16-36(39,17-20-43)35(48)49)42-33(46)30(23-26-13-7-4-8-14-26)41-31(44)27(38)22-25-11-5-3-6-12-25;1-2(3)4/h3-8,11-14,24,27-30H,9-10,15-23,37-39H2,1-2H3,(H,40,45)(H,41,44)(H,42,46)(H,48,49);1H3,(H,3,4)/t27-,28-,29-,30-;/m1./s1
    2.1.3 InChI Key
    MZWHRPKAHCWTOI-KGURMGBCSA-N
    2.2 Other Identifiers
    2.2.1 UNII
    0P70AR5BYB
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-piperidinecarboxylic Acid, 4-amino-1-((2r)-6-amino-2-(((2r)-2-(((2r)-2-(((2r)-2-amino-1-oxo-3-phenylpropyl)amino)-1-oxo-3-phenylpropyl)amino)-4-methyl-1-oxopentyl)amino)-1-oxohexyl)-

    2. Difelikefalin

    3. Korsuva

    4. N-((2r)-1-(((2r)-1-(((2r)-6-amino-1-(4-amino-4-carboxy-1-piperidinyl)-1-oxo-2-hexanyl)amino)-4-methyl-1-oxo-2-pentanyl)amino)-1-oxo-3-phenyl-2-propanyl)-d-phenylalaninamide

    2.3.2 Depositor-Supplied Synonyms

    1. Cr845 Acetate

    2. Cr-845 Acetate

    3. 1024829-44-4

    4. Unii-0p70ar5byb

    5. 0p70ar5byb

    6. Korsuva

    7. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysl)-piperidine-4-carboxylic Acid, Acetate Salt

    8. Acetic Acid;4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic Acid

    9. Difelikefalin (acetate)

    10. Chembl5315123

    11. Hy-17609c

    12. 1024828-77-0 , Difelikefalin

    13. Difelikefalin Acetate [who-dd]

    14. Ac-38232

    15. Ts-10624

    16. Difelikefalin Acetate [orange Book]

    17. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)piperidine-4-carboxylic Acid Acetate

    18. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:)

    19. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:?)

    2.4 Create Date
    2015-09-11
    3 Chemical and Physical Properties
    Molecular Weight 739.9 g/mol
    Molecular Formula C38H57N7O8
    Hydrogen Bond Donor Count8
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count18
    Exact Mass Da
    Monoisotopic Mass Da
    Topological Polar Surface Area260
    Heavy Atom Count53
    Formal Charge0
    Complexity1110
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2

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    Cara Therapeutics: Outcome of KOURAGE-1 Study on Oral Difelikefalin in Notalgia

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    Korsuva (difelikefalin) is a kappa opioid receptor agonists. Its oral formulation is under development for the treatment of moderate-to-severe pruritus in adult patients with notalgia paresthetica.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Phase II/ Phase IIIProduct Type: Peptide

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    Cara Therapeutics: Outcome of KOURAGE-1 Study on Oral Difelikefalin in Notalgia

    Details : Korsuva (difelikefalin) is a kappa opioid receptor agonists. Its oral formulation is under development for the treatment of moderate-to-severe pruritus in adult patients with notalgia paresthetica.

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    Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difelikefalin for Moderate-to-Severe Pruritus in Patients w...

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    CR845 (difelikefalin) is a kappa opioid receptor agonists. Its oral formulation is under clinical development for the treatment of moderate-to-severe pruritus in patients with Atopic Dermatitis.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Phase IIIProduct Type: Peptide

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    Highest Development Status : Phase III

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    Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difel...

    Details : CR845 (difelikefalin) is a kappa opioid receptor agonists. Its oral formulation is under clinical development for the treatment of moderate-to-severe pruritus in patients with Atopic Dermatitis.

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    Cara Therapeutics Announces Approval of KORSUVA® IV Injection Syringe in Japan for the Treatment of Pruritus in Hemodialysis Patients

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    Korsuva (difelikefalin) injection is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus in hemodialysis patients.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: Maruishi Pharmaceutical

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    Therapeutic Area : Dermatology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Maruishi Pharmaceutical

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    Cara Therapeutics Announces Approval of KORSUVA® IV Injection Syringe in Japan for the Treatment ...

    Details : Korsuva (difelikefalin) injection is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus in hemodialysis patients.

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    Cara Therapeutics Announces Results from the KOMFORT Phase 2 Trial of Oral Difelikefalin for the Treatment of Pruritus in Notalgia Paresthetica Publishe...

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    CR845 (difelikefalin) is an oral agonist of kappa opioid receptors (KORs) It is being developed for the treatment of pruritus secondary to chronic kidney disease and notalgia paresthetica.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Neurology Brand Name: Korsuva

    Study Phase: Phase IIProduct Type: Peptide

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    Deal Type: Inapplicable August 02, 2023

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    Highest Development Status : Phase II

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    Cara Therapeutics Announces Results from the KOMFORT Phase 2 Trial of Oral Difelikefalin for the T...

    Details : CR845 (difelikefalin) is an oral agonist of kappa opioid receptors (KORs) It is being developed for the treatment of pruritus secondary to chronic kidney disease and notalgia paresthetica.

    Product Name : Korsuva

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    Kapruvia® (difelikefalin) Recommended By England's NICE For the Treatment of Adults with Moderate-To-Severe CKD-Associated Pruritus

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    Kapruvia® (difelikefalin) is a selective kappa opioid receptor agonist with low central nervous system penetration. It is recommended by NICE for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Nephrology Brand Name: Kapruvia

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: CARA Therapeutics

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 18, 2023

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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Nephrology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : CARA Therapeutics

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Kapruvia® (difelikefalin) Recommended By England's NICE For the Treatment of Adults with Moderate...

    Details : Kapruvia® (difelikefalin) is a selective kappa opioid receptor agonist with low central nervous system penetration. It is recommended by NICE for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis.

    Product Name : Kapruvia

    Product Type : Peptide

    Upfront Cash : Inapplicable

    May 18, 2023

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    Cara Therapeutics Announces up to $40.0 Million Non-Dilutive Financing Agreement with HealthCare Royalty

    Details:

    Cara intends to use the proceeds from the agreement to support the ongoing clinical development of its oral CR845 (difelikefalin) pipeline, including late-stage programs for pruritus associated with atopic dermatitis, advanced chronic kidney disease, and notalgia paresthetica.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Phase IIProduct Type: Peptide

    Sponsor: HealthCare Royalty

    Deal Size: $40.0 million Upfront Cash: Undisclosed

    Deal Type: Financing February 11, 2023

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    06

    CARA Therapeutics

    U.S.A
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    CARA Therapeutics

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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : HealthCare Royalty

    Deal Size : $40.0 million

    Deal Type : Financing

    DEALS_DEV arrow-down

    Cara Therapeutics Announces up to $40.0 Million Non-Dilutive Financing Agreement with HealthCare R...

    Details : Cara intends to use the proceeds from the agreement to support the ongoing clinical development of its oral CR845 (difelikefalin) pipeline, including late-stage programs for pruritus associated with atopic dermatitis, advanced chronic kidney disease, and...

    Product Name : Korsuva

    Product Type : Peptide

    Upfront Cash : Undisclosed

    February 11, 2023

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    SWK Holdings' Subsidiary, Enteris BioPharma, Receives $5 Million Milestone Payment from Cara Therapeutics

    Details:

    The milestone payment is related to continued clinical progress of Oral KORSUVA (difelikefalin), which is currently the subject of four separate clinical programs for pruritus in patients with hepatic impairment due to primary biliary cholangitis.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Phase IIProduct Type: Peptide

    Sponsor: CARA Therapeutics

    Deal Size: $46.0 million Upfront Cash: $8.0 million

    Deal Type: Licensing Agreement October 10, 2022

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    07

    Enteris Biopharma Inc

    U.S.A
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    Enteris Biopharma Inc

    U.S.A
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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : CARA Therapeutics

    Deal Size : $46.0 million

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    SWK Holdings' Subsidiary, Enteris BioPharma, Receives $5 Million Milestone Payment from Cara Thera...

    Details : The milestone payment is related to continued clinical progress of Oral KORSUVA (difelikefalin), which is currently the subject of four separate clinical programs for pruritus in patients with hepatic impairment due to primary biliary cholangitis.

    Product Name : Korsuva

    Product Type : Peptide

    Upfront Cash : $8.0 million

    October 10, 2022

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    Cara Therapeutics Announces KOMFORT Data Accepted for Late-Breaking Presentation at the 31st EADV Congress

    Details:

    KOMFORT Phase 2 clinical trial evaluating oral Korsuva (difelikefalin) for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica will be presented during a late-breaking news session.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Korsuva

    Study Phase: Phase IIProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 22, 2022

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    08

    CARA Therapeutics

    U.S.A
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    CARA Therapeutics

    U.S.A
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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Dermatology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cara Therapeutics Announces KOMFORT Data Accepted for Late-Breaking Presentation at the 31st EADV ...

    Details : KOMFORT Phase 2 clinical trial evaluating oral Korsuva (difelikefalin) for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica will be presented during a late-breaking news session.

    Product Name : Korsuva

    Product Type : Peptide

    Upfront Cash : Inapplicable

    August 22, 2022

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    Kapruvia® Approved in Switzerland With Additional Regulatory Decisions Expected in H2 2022

    Details:

    Kapruvia® (difelikefalin) will be the first therapy available for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Dermatology Brand Name: Kapruvia

    Study Phase: Approved FDFProduct Type: Peptide

    Sponsor: CARA Therapeutics

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 19, 2022

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    09

    Vifor Pharma

    Country
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    Vifor Pharma

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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Dermatology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : CARA Therapeutics

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Kapruvia® Approved in Switzerland With Additional Regulatory Decisions Expected in H2 2022

    Details : Kapruvia® (difelikefalin) will be the first therapy available for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients.

    Product Name : Kapruvia

    Product Type : Peptide

    Upfront Cash : Inapplicable

    August 19, 2022

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    Cara Therapeutics Presents Late-Breaking Results of the KOMFORT Phase 2 Trial of Oral Difelikefalin for Pruritus in Notalgia Paresthetica at the 31st EA...

    Details:

    The primary efficacy endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8 was achieved for Korsuva (difelikefalin) vs. -2.4 placebo, p=0.001.


    Lead Product(s): Difelikefalin Acetate

    Therapeutic Area: Neurology Brand Name: Korsuva

    Study Phase: Phase IIProduct Type: Peptide

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 09, 2022

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    10

    CARA Therapeutics

    U.S.A
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    CARA Therapeutics

    U.S.A
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    Lead Product(s) : Difelikefalin Acetate

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Cara Therapeutics Presents Late-Breaking Results of the KOMFORT Phase 2 Trial of Oral Difelikefali...

    Details : The primary efficacy endpoint of change from baseline in the weekly mean of the daily 24-hour Worst Itch-Numeric Rating Scale (WI-NRS) score at Week 8 was achieved for Korsuva (difelikefalin) vs. -2.4 placebo, p=0.001.

    Product Name : Korsuva

    Product Type : Peptide

    Upfront Cash : Inapplicable

    August 09, 2022

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