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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.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: CR845
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
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
Therapeutic Area: Dermatology Product Name: CR845
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: HealthCare Royalty
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Financing November 02, 2023
Details:
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
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Maruishi Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2023
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.
Lead Product(s): Difelikefalin
Therapeutic Area: Nephrology Product Name: Kapruvia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2023
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.
Lead Product(s): Difelikefalin
Therapeutic Area: Neurology Product Name: CR845
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2023
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
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: $46.0 million Upfront Cash: $8.0 million
Deal Type: Licensing Agreement October 10, 2022
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
Therapeutic Area: Neurology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2022
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
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 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
Therapeutic Area: Dermatology Product Name: Kapruvia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2022
Details:
Patients treated with oral Korsuva (difelikefalin) achieved the primary endpoint (-4.0 difelikefalin vs. -2.4 placebo, p=0.001) with significant improvement observed as early as Week 1 and sustained through Week 8.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2022
Details:
Studies showed that treatment with Kapruvia® resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-associated pruritus.
Lead Product(s): Difelikefalin
Therapeutic Area: Nephrology Product Name: Kapruvia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Poster highlights reduction in itch intensity with Kapruvia (difelikefalin) treatment correlated with reductions in inflammatory markers in patients with chronic kidney disease-associated pruritus undergoing hemodialysis.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Kapruvia
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
The positive CHMP opinion is based on pivotal clinical data for KALM-1 and KALM-2 trial, for Kapruvia® (difelikefalin), as first therapy in Europe for the treatment of chronic kidney disease associated-pruritus (CKD-aP) in hemodialysis patients.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Kapruvia
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
Enteris is eligible to receive additional potential milestone payments over the next several quarters, subject to the achievement of certain development milestones for Oral KORSUVA, of which Enteris will retain half.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: $25.0 million Upfront Cash: $5.0 million
Deal Type: Licensing Agreement December 09, 2021
Details:
KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist used for the treatment of moderate-to-severe pruritus in mild-to-severe atopic dermatitis (AD) patients.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
This milestone payment was triggered by confirmation from Cara of the completion of an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) for Oral KORSUVA in patients with non-dialysis dependent (NDD) chronic kidney disease (CKD-aP).
Lead Product(s): Difelikefalin
Therapeutic Area: Nephrology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: Undisclosed Upfront Cash: $8.0 million
Deal Type: Licensing Agreement June 11, 2021
Details:
Statistically significant improvement in 4-point responder analysis in mild-to-moderate (BSA <10%) AD patients with 32% of KORSUVA-treated patients achieving a > 4-point reduction vs. 19% in placebo group.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
Details:
The Phase 2 multicenter, randomized, double-blind, placebo-controlled 8-week study is designed to evaluate the efficacy and safety of Oral KORSUVA™ for moderate-to-severe pruritus in approximately 120 subjects with NP.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
The NDA submission is supported by positive data from two pivotal Phase 3 trials of KORSUVA Injection, including the KALM-1 trial conducted in the U.S. and the global KALM-2 trial, as well as supportive data from an additional 32 clinical studies.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2020
Details:
Enteris BioPharma, received a second milestone payment from Cara Therapeutics (Nasdaq: CARA) related to the license agreement for Peptelligence oral formulation technology utilized in Oral KORSUVA, the oral formulation of Cara’s first-in-class KOR agonist, CR845/difelikefalin.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Peptide
Partner/Sponsor/Collaborator: CARA Therapeutics
Deal Size: $13.0 million Upfront Cash: $8.0 million
Deal Type: Licensing Agreement December 24, 2020
Details:
The trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a three-point or greater improvement from baseline in the weekly mean Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo at week 12.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
Vifor Pharma secures commercial rights for IV Korsuva in non-Fresenius Medical Care dialysis clinics representing approx. 66% of the market, under a profit-sharing arrangement with Cara.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: CSL Vifor
Deal Size: $150.0 million Upfront Cash: $100.0 million
Deal Type: Licensing Agreement October 20, 2020
Details:
Patient enrollment increased approximately 28% to maintain >80% statistical power for primary endpoint and key registration endpoint of >4-point improvement responder analysis.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Korsuva
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2020
Details:
KORSUVA Injection was generally well-tolerated with a safety profile consistent with that seen in KALM-1 and the KORSUVA clinical program in patients with CKD-aP.
Lead Product(s): Difelikefalin
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2020
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