A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus

This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

Start Date18 Jun 2024

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

NCT05978063 / TerminatedPhase 2/3

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.

Start Date01 Aug 2023

Sponsor / Collaborator

CARA Therapeutics, Inc.

NCT05885763 / CompletedPhase 1

A Phase 1, Single-arm, Open-label Study to Evaluate the Pharmacokinetics and Safety of Intravenous Difelikefalin in Adult Chinese Subjects on Haemodialysis

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

Start Date26 Jun 2023

Sponsor / Collaborator

Vifor Fresenius Medical Care Renal Pharma Ltd.

[+1]

100 Clinical Results associated with Difelikefalin

100 Translational Medicine associated with Difelikefalin

100 Patents (Medical) associated with Difelikefalin

Literatures (Medical) associated with Difelikefalin

01 Feb 2024·Nephrologie & therapeutique

Article

Author: Rostoker, Guy ; Chauveau, Philippe ; Florens, Nans ; Lanot, Antoine ; Bataille, Pierre ; Testa, Angelo ; Misery, Laurent ; Touzot, Maxime

Chronic kidney disease-associated pruritus (CKD-aP) is a disabling symptom which is frequent and often underestimated. Pa-MRC has a negative impact on quality of life, and is frequently accompanied by sleep disorders and depression. The approval of difelikefalin – a kappa opioid receptor agonist – in this indication requires updated recommendations. As a first step, secondary causes of pruritus without skin lesions must be ruled out, and general measures taken (emollients, psychological support, optimization of dialysis, normalization of serum calcium, phosphate and PTH in the range proposed by the KGIDO guidelines, treatment of iron deficiency). A therapeutic test with a non-sedating oral antihistamine may be proposed. If this test is negative, Pa-MRC must be strongly suspected, and its intensity (WI-NRS scale) and impact on quality of life assessed. In the case of mild Pa-MRC (WI-NRS ≤ 3), only general measures are implemented. If Pa-MRC is moderate to severe (WI-NRS ≥ 4), specific treatment with difelikefaline can be initiated for 6 months in addition to general measures. At 3 months, if the response is complete (WI-NRS score ≤ 1) or partial (decline ≥ 3 points), treatment is continued. At 6 months, if the response is complete, treatment may be discontinued with the patient’s agreement; treatment is maintained if the response is partial. At 3 or 6 months, if response is insufficient (decline < 3 points) and/or in the event of intolerance, treatment is discontinued and an alternative treatment (e.g., gabapentinoids, UVB) may be considered after dermatological consultation.

01 Apr 2024·Clinical nephrology

Efficacy and safety of difelikefalin in the treatment of hemodialysis patients with pruritus: A meta-analysis and systematic review

Review

Author: Fan, Dandan ; Yang, Yujie ; Liu, Jing ; Xue, Guifang ; Yuan, Huaihong ; Ma, Chunyan ; Liao, Ruoxi

BACKGROUND:

The incidence of pruritus associated with hemodialysis (HD) patients can be as high as 70%, and ~ 40% of patients suffer from moderate to severe systemic pruritus. Difelikefalin (CR845), a peripheral restrictor κ-opioid receptor agonist, activates opioid receptors on peripheral neurons and immune cells to relieve pruritus in patients. However, the clinical effect of difelikefalin on HD-related pruritus is unclear. Therefore, the purpose of this meta-analysis and systematic review was to investigate the safety and efficacy of difelikefalin in the treatment of HD-associated pruritus.

OBJECTIVE:

This study explored the efficacy and safety of difelikefalin in the treatment of pruritus in HD patients by systematic review and meta-analysis.

MATERIALS AND METHODS:

Randomized controlled trials on difelikefalin in the treatment of pruritus in HD patients were retrieved from PubMed, Embase, Cochrane Library, and Web of Science electronic databases. The retrieval deadline was January 1, 2023. Stata 15.0 software was used for data analysis of the included studies.

RESULTS:

A total of 4 randomized controlled trials were included, totaling 1,268 patients (736 patients in the experimental group and 532 patients in the control group). Results of the meta-analysis showed that, compared with the control group, difelikefalin could significantly improve the Worst Itch Numeric Rating Scale score (improvement > 3; risk ratio (RR) = 1.28, 95% confidence interval (CI) (1.07, 1.53)), decrease the 5-D itch score (standardized mean difference = -0.43, 95% CI (-0.55, -0.30)), and significantly improve adverse events (RR = 1.33, 95% CI (1.13, 1.56)).

CONCLUSION:

Although difelikefalin can improve itching symptoms in HD patients, it can also increase adverse reactions based on the current literature. Therefore, more studies are needed to further explore the safety and efficacy of difelikefalin treatment.

American journal of nephrology

Difelikefalin in Black/African American Hemodialysis Patients with Moderate-to-Severe Pruritus: Post hoc Analysis of KALM-1 and KALM-2

Article

Author: Lerma, Edgar V ; Wen, Warren ; Budden, Jeffrey ; Clegg, Deborah J ; Menzaghi, Frédérique ; Topf, Joel ; Morin, Isabelle ; Fishbane, Steven ; Rastogi, Anjay

Introduction: Black and African American (AA) people are over-represented in the kidney failure population; therefore, the safety and efficacy of difelikefalin in Black/AA patients was evaluated. Methods: This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies. Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups. Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks. Difelikefalin efficacy was assessed with validated patient-reported outcome questionnaires: 24-h Worst Itch Numerical Rating Scale (WI-NRS), 5-D itch, and Skindex‑10. Results: There were 249 (29.3%) patients from the KALM studies that self-identified as Black/AA (n = 135 difelikefalin; n = 114 placebo). Clinically meaningful (≥3-point) reduction in WI-NRS score was achieved by 47.9% of Black/AA patients with difelikefalin versus 24.6% with placebo (p < 0.001). More Black/AA patients achieved a ≥5-point 5-D itch total improvement (54.9% vs. 35.7%; p = 0.013) and a ≥15-point Skindex-10 score improvement with difelikefalin versus placebo (49.0% vs. 28.9%; p = 0.006) compared with White patients. Incidence of treatment-emergent adverse events (TEAEs) was higher for Black/AA patients (difelikefalin: 78.5%; placebo: 70.8%) versus White patients (difelikefalin: 64.8%; placebo: 61.8%). Conclusion: In this post hoc analysis, difelikefalin was efficacious in the Black/AA population and had an acceptable safety profile.

News (Medical) associated with Difelikefalin

12 Jun 2024

·www.biospace.com

Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

– Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo – – Company will discontinue clinical program in NP and explore strategic alternatives – STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP). Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company’s decision to discontinue the clinical program in NP. “Given our strong proof-of-concept results in NP and the significant unmet need in this sensory neuropathy, we are disappointed that oral difelikefalin did not demonstrate a meaningful improvement in pruritus compared to placebo in the KOURAGE-1 Part A study,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We are grateful for the patients and investigators who participated in this study. We will be winding down the Phase 2/3 clinical program in NP and exploring strategic alternatives focused on maximizing shareholder value.” KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. In Part A, 214 patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. The primary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety pro to prior trials. As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit and follow the company on X (Twitter), LinkedIn and Instagram. Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the winding down of the Company’s Phase 2/3 clinical program in NP, the exploration of strategic alternatives and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. MEDIA CONTACT: Annie Spinetta 6 Degrees 973-768-2170 aspinetta@6degreespr.com INVESTOR CONTACT: Iris Francesconi, Ph.D. Cara Therapeutics 203-406-3700 investor@caratherapeutics.com

Clinical ResultDrug ApprovalPhase 3

13 May 2024

·www.globenewswire.com

Cara Therapeutics Reports First Quarter 2024 Financial Results

Topline efficacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end of 2Q24STAMFORD, Conn., May 13, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2024. “Our notalgia paresthetica (NP) pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We believe the medical dermatology community’s interest in our clinical program underscores the significant unmet need for an effective and safe anti-pruritic treatment for the sizeable NP patient population. We look forward to rapidly advancing the ongoing Phase 2/3 program of our differentiated asset, oral difelikefalin, in this common but under-explored sensory neuropathy.” KOURAGE Update KOURAGE 1 Part A is the dose-finding portion of the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP. The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024. Part A is not powered for statistical significance. This readout will provide key information, specifically the dose and sample size to initiate the Phase 3 pivotal portion of the program – Part B of KOURAGE 1 and the second study KOURAGE 2. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026. In March 2024, the Company hosted a virtual event, Meet the NP Experts, featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet need in NP and the potential of oral difelikefalin. A replay of the webcast is available under “Events & Presentations” in the Investors section of the Company’s website, www.CaraTherapeutics.com. 1Q24 KORSUVA Injection U.S. Update In the first quarter of 2024, KORSUVA® (difelikefalin) injection generated net sales of approximately $1.8 million and the Company recorded collaborative revenue of approximately $800,000, which represented the Company’s share of the profit from sales of KORSUVA injection. Wholesalers shipped 111,720 vials to dialysis centers during the first quarter of 2024. On March 31, 2024, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection expired. After the TDAPA period, KORSUVA injection is reimbursed through the ESRD PPS bundle. First Quarter 2024 Financial Results Cash, cash equivalents and marketable securities at March 31, 2024 totaled $69.8 million compared to $100.8 million at December 31, 2023. The decrease in the balance primarily resulted from $30.5 million of cash used in operating activities. For the first quarter of 2024, net loss was $30.7 million, or $(0.56) per basic and diluted share, compared to net loss of $26.7 million, or ($0.49) per basic and diluted share, for the same period in 2023. Revenues: Total revenue was $2.1 million and $6.2 million for the three months ended March 31, 2024 and 2023, respectively. Revenue primarily consisted of: $0.8 million and $2.8 million of collaborative revenue related to our share of the profit from CSL Vifor’s sales of KORSUVA injection to third parties during the three months ended March 31, 2024 and 2023, respectively.$0.6 million and $3.2 million of commercial supply revenue related to sales of KORSUVA injection to CSL Vifor during the three months ended March 31, 2024 and 2023, respectively.$0.6 million of other revenue related to royalty payments earned in conjunction with ex U.S. sales of KORSUVA/Kapruvia under agreements with CSL Vifor and Maruishi Pharmaceuticals Co. Ltd., or Maruishi, during the three months ended March 31, 2024, which were sold under the Purchase and Sale agreement with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or the HCR Agreement, and considered non-cash. There was no other revenue during the three months ended March 31, 2023. Cost of Goods Sold: Cost of goods sold was $0.6 million and $2.6 million for the three months ended March 31, 2024 and 2023, respectively, related to commercial supply revenue for KORSUVA injection sales to CSL Vifor. Research and Development (R&D) Expenses: R&D expenses were $22.0 million for the three months ended March 31, 2024 compared to $24.3 million in the same period of 2023. The lower R&D expenses in 2024 were primarily due to decreases in stock-based compensation expense, payroll and related costs, travel costs and other related conference costs as well as lower costs associated with the discontinuation of our atopic dermatitis and advanced chronic kidney disease programs, partially offset by increases related to the oral difelikefalin NP program. General and Administrative (G&A) Expenses: G&A expenses were essentially flat at $6.8 million for the three months ended March 31, 2024 compared to $6.9 million in the same period of 2023. Restructuring Expenses: Restructuring expenses were $2.4 million for the three months ended March 31, 2024 which were related to our strategic prioritization of NP and the associated workforce reduction in the 2024 period. There were no restructuring expenses recorded during the three months ended March 31, 2023. Other Income, net: Other income, net was approximately $1.0 million for each of the three months ended March 31, 2024 and 2023. Non-cash interest expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $2.0 million which represented imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance costs associated with the HCR Agreement for the three months ended March 31, 2024. There was no non-cash interest expense for the three months ended March 31, 2023. Financial Guidance Cara expects that our current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund our currently anticipated operating plan into 2026. Our current operating plan assumes certain costs related to our planned pivotal trials in NP. About the KOURAGE Phase 2/3 Clinical Program in Notalgia Paresthetica KOURAGE is a Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica (NP). The program is comprised of two studies – KOURAGE 1 and KOURAGE 2 – which will likely be double-blind, placebo-controlled, 8-week studies with patients allowed to roll-over into open-label 52-week extensions. KOURAGE 1 is composed of two parts. The dose-finding portion of KOURAGE 1 (Part A) includes 214 patients who are randomized equally to four arms (0.25 mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). Part A is not powered for statistical significance. Part B and KOURAGE 2 will likely be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching placebo. The primary endpoint for both the dose-finding portion of KOURAGE 1 (Part A) and the two pivotal studies Part B and KOURAGE 2 will likely be the proportion of patients with a ≥4-point improvement at Week 8 from baseline in the worst itch numeric rating scale. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company is developing an oral formulation of difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor agonist, for the treatment of chronic pruritus associated with notalgia paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back for which there are no FDA-approved therapies. The Company is conducting a Phase 2/3 clinical program in NP with topline results of the dose-finding portion expected by the end of the second quarter of 2024. Cara Therapeutics also developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram. Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the Company’s planned future regulatory submissions and potential future regulatory approvals, future product launches, expected timing of the initiation, enrollment and data readouts from the Company’s planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company’s product candidate, the potential for the Company’s product candidate to be an alternative in the therapeutic areas investigated, including notalgia paresthetica, the size and growth of the potential markets for pruritus management such as notalgia paresthetica, the commercial potential of the Company’s product candidate, and the Company’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$46,996 $ 51,775 Marketable securities 22,777 48,983 Accounts receivable, net - related party 1,718 2,765 Inventory, net 2,741 2,821 Income tax receivable 697 697 Other receivables 506 555 Prepaid expenses 5,790 8,154 Restricted cash - 408 Total current assets 81,225 116,158 Operating lease right-of-use assets 3,826 4,864 Property and equipment, net 3,548 3,322 Restricted cash, non-current 1,500 1,500 Total assets$90,099 $125,844 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses$14,875 $25,592 Operating lease liability, current 220 - Total current liabilities 15,095 25,592 Liability related to sales of future royalties and milestones, net 38,376 37,079 Operating lease liability, non-current 6,825 6,088 Total liabilities 60,296 68,759 Commitments and contingencies - - Stockholders' equity: Preferred stock - - Common stock 54 54 Additional paid-in capital 745,381 742,036 Accumulated deficit (715,441) (684,745)Accumulated other comprehensive loss (191) (260)Total stockholders’ equity 29,803 57,085 Total liabilities and stockholders’ equity$90,099 $125,844 CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(amounts in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2024 2023 Revenue: Collaborative revenue$788 $2,750 Commercial supply revenue 640 3,191 Royalty revenue - 125 Clinical compound revenue 84 99 Other revenue 623 - Total revenue 2,135 6,165 Operating expenses: Cost of goods sold 620 2,590 Research and development 21,964 24,334 General and administrative 6,816 6,891 Restructuring 2,401 - Total operating expenses 31,801 33,815 Operating loss (29,666) (27,650) Other income, net 952 985 Non-cash interest expense on liability related to sales of future royalties and milestones (1,982) - Net loss$(30,696) $(26,665) Net loss per share: Basic and Diluted$(0.56) $(0.49) Weighted average shares: Basic and Diluted 54,588,090 53,872,038 MEDIA CONTACT:Annie Spinetta6 Degrees973-768-2170aspinetta@6degreespr.com INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara Therapeutics203-406-3700investor@caratherapeutics.com

Financial StatementDrug ApprovalPhase 3

06 May 2024

·www.biospace.com

Cara Therapeutics to Announce First Quarter 2024 Financial Results on May 13, 2024

STAMFORD, Conn., May 06, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the Company will report first quarter 2024 financial results on Monday, May 13, 2024, after the U.S. markets close. The press release will be available under “Press Releases” in the Investors section of the Company’s website at . About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company is developing an oral formulation of difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor agonist, for the treatment of chronic pruritus associated with notalgia paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back for which there are no FDA-approved therapies. The Company is conducting a Phase 2/3 clinical program in NP with topline results of the dose-finding portion expected in the third quarter of 2024. Cara Therapeutics also developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit and follow the company on X (Twitter), LinkedIn and Instagram. MEDIA CONTACT: Annie Spinetta 6 Degrees 973-768-2170 aspinetta@6degreespr.com INVESTOR CONTACT: Iris Francesconi, Ph.D. Cara Therapeutics 203-406-3700 investor@caratherapeutics.com

Drug ApprovalFinancial Statement

100 Deals associated with Difelikefalin

External Link

KEGG	Wiki	ATC	Drug Bank
D11111	Difelikefalin	-	DB11938

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pruritus	US	CARA Therapeutics, Inc.	23 Aug 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 3	US	CARA Therapeutics, Inc.	16 Aug 2022
Chronic Kidney Diseases	Phase 3	US	CARA Therapeutics, Inc.	17 May 2022
Pain	Phase 3	US	CARA Therapeutics, Inc.	30 Jan 2022
Pain	Phase 3	KR	Chong Kun Dang Pharmaceutical Corp.	30 Jan 2022
Uremic pruritus	Phase 3	US	CARA Therapeutics, Inc.	14 Aug 2017
Uremic pruritus	Phase 3	PR	CARA Therapeutics, Inc.	14 Aug 2017
Pain, Postoperative	Phase 3	US	CARA Therapeutics, Inc.	-
Pain, Postoperative	Phase 3	-	Chong Kun Dang Pharmaceutical Corp.	-
Pain, Postoperative	Phase 3	-	Ferring BV	-
Pain, Postoperative	Phase 3	-	Maruishi Pharmaceutical Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03617536 (CTgov)	Phase 2	Pruritus \| Chronic Kidney Diseases	269	CR845 0.25 mg Oral Tablet (CR845 0.25 mg Oral Tablet)	znwhshdoqu(ntniwkiprw) = dkonzhybsh gvnutquqiu (qfyrfwfmtm, odtrktduyv - pcahjjprph) View more	-	24 Jan 2024
				CR845 0.5 mg Oral Tablet (CR845 0.5 mg Oral Tablet)	znwhshdoqu(ntniwkiprw) = ewmezehkit gvnutquqiu (qfyrfwfmtm, vebjnvwfrv - pqxkuvecpy) View more
KIND 1 (Biospace) Manual	Phase 3	Dermatitis, Atopic Adjuvant	287	difelikefalin+TCS	mxyywahwjj(gkigccymyk) = Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone. fzezlyraff (usblgwrlve ) View more	Negative	18 Dec 2023
				placebo +TCS
NCT03947970 (Pubmed)	Phase 1	-	12	[14C]Difelikefalin (Healthy subjects)	awolyxdezz(ngivsnjcag) = knxzioihzl slielqhldt (rtdhpovitt ) View more	-	28 Jun 2023
				[14C]Difelikefalin (Subjects on Hemodialysis)	awolyxdezz(ngivsnjcag) = mhclmbjikp slielqhldt (rtdhpovitt ) View more
NCT04706975 (KOMFORT, Biospace) Manual	Phase 2	Pruritus	125	Difelikefalin	bhozttqojs(ucscumcxsf) = ykibkexejy bzgvnihnvl (vigbprgpjv ) View more	Positive	08 Sep 2022
				Placebo	bhozttqojs(ucscumcxsf) = cnqdjgsyxv bzgvnihnvl (vigbprgpjv ) View more
NCT03998163 (Study 3105 \| CR845-CLIN3105, Pubmed) Manual	Phase 3	Pruritus	222	Difelikefalin	xicomkgkzj(geprorqedm) = hcyojeswot jsbllbaloq (fjfnxivqwa ) View more	Positive	24 Aug 2022
NCT03281538 \| NCT03636269 \| NCT03422653 \| NCT03998163 (CR845-CLIN3105, Pubmed)	Phase 3	Uremic pruritus	-	Difelikefalin	nbdzrnphti(qaphfbqmtu) = alosqmknzp mvcvasouqc (vbrswuwuoe ) View more	Positive	01 Aug 2022
				Placebo	nbdzrnphti(qaphfbqmtu) = szxsrtaazk mvcvasouqc (vbrswuwuoe ) View more
NCT03636269 \| NCT03422653 (KALM-1 \| KALM-2, Pubmed) Manual	Phase 3	Pruritus	851	Difelikefalin	bmmdvyubkp(drbhokwvxo) = xcnqrviuza ivkjpcxdhw (ysoydoavwx ) View more	Positive	28 Jun 2022
				Placebo	bmmdvyubkp(drbhokwvxo) = kymtrfzyri ivkjpcxdhw (ysoydoavwx ) View more
NCT03422653 (KALM-1, CTgov)	Phase 3	Uremic pruritus	378	CR845 0.5 mcg/kg (CR845 0.5mcg/kg)	rnjrpsgzsf(tblcndvivf) = ejolmamtcs erhzzwcsfy (nflwnewalu, fmbpdrqqaw - rpjqcoeodk)	-	26 Apr 2022
				Placebo (Placebo)	rnjrpsgzsf(tblcndvivf) = onbfxcvjmv erhzzwcsfy (nflwnewalu, nzvtehurux - xjvaiudqbv)
NCT03636269 (KALM-2 \| CR845-CLIN3103, CTgov)	Phase 3	Uremic pruritus	473	CR845 0.5 mcg/kg (CR845 0.5mcg/kg)	frfkuhgglo(dohbqwhjrt) = dyqkttibll bbgxcezhxn (ounmtrxsey, xcwtlyidcb - ilkqktouip)	-	26 Apr 2022
				Placebo (Placebo)	frfkuhgglo(dohbqwhjrt) = dvubxhiyrc bbgxcezhxn (ounmtrxsey, ablkpzaipa - vctrutymvi)
NCT04711603 (Corporate Publications) Manual	Phase 3	Pruritus	-	Difelikefalin	ijlznpwnlj(fsrtyfcyfk) = the primary endpoint was achieved in a Japanese Phase 3 clinical study ojhlybklbk (niomfiyjfx ) Met View more	Positive	10 Jan 2022
				Placebo

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