Cara Therapeutics

🇺🇸United States

Country: 🇺🇸United States

Ownership: Public

Established: 2004-07-02

Employees: 55

Market Cap: $19.6M

Website: http://www.caratherapeutics.com

Introduction: CARA Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs). Its portfolio includes opioid-based products, anesthetic-based drugs, and analgesics that targets to alleviate itch and pain. The company was founded by Derek T. Chalmers, Michael E. Lewis, and Frederique Menzaghi on July 2, 2004 and is headquartered in Stamford, CT.

Clinical Trials

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

Phase 2

Terminated

Conditions: Pruritus
Notalgia Paresthetica

Interventions: Drug: difelikefalin 2.0 mg tablets
Drug: difelikefalin 0.25 mg tablets
Drug: difelikefalin 1.0 mg tablets
Drug: Placebo tablets

First Posted Date: 2023-08-07

Last Posted Date: 2024-06-21

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 214

Registration Number: NCT05978063

Locations: 🇪🇸
Cara Therapeutics Study Site, Madrid, Spain
🇵🇱
Cara Therapeutics Study Site 2, Katowice, Poland

CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

Phase 1

Completed

Conditions: Hemodialysis

Interventions: Drug: CR845 0.5 mcg/kg
Other: Placebo

First Posted Date: 2022-09-08

Last Posted Date: 2022-09-08

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 35

Registration Number: NCT05533008

Locations: 🇺🇸
Cara Therapeutics Study Site, Minneapolis, Minnesota, United States

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Phase 3

Terminated

Conditions: Pruritus
Atopic Dermatitis

Interventions: Drug: difelikefalin 0.5 mg
Drug: difelikefalin 0.25 mg
Drug: TCS Cream
Drug: Placebo
Drug: Vehicle Cream

First Posted Date: 2022-05-24

Last Posted Date: 2024-02-22

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 287

Registration Number: NCT05387707

Locations: 🇺🇸
Cara Therapeutics Study Site, Morgantown, West Virginia, United States
🇺🇸
Cara Therapeutics Study Site 2, Santa Monica, California, United States

CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Phase 3

Terminated

Conditions: Chronic Kidney Diseases
Pruritus

Interventions: Drug: Placebo Oral Tablet
Drug: Difelikefalin 1 mg Oral Tablet

First Posted Date: 2022-05-02

Last Posted Date: 2024-05-07

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 105

Registration Number: NCT05356403

Locations: 🇪🇸
Cara Therapeutics Study Site, Vitoria, Spain
🇪🇸
Cara Therapeutics Study Site 2, Valencia, Spain

A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Phase 3

Terminated

Conditions: Chronic Kidney Diseases
Pruritus

Interventions: Drug: Difelikefalin 1 mg Oral Tablet
Drug: Placebo Oral Tablet

First Posted Date: 2022-04-22

Last Posted Date: 2024-05-07

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 286

Registration Number: NCT05342623

Locations: 🇺🇸
Cara Therapeutics Study Site 2, Houston, Texas, United States
🇺🇸
Cara Therapeutics Study Sites, Corsicana, Texas, United States
🇺🇸
Cara Therapeutics Study Site, Hampton, Virginia, United States

Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

Conditions: Uremic Pruritus

First Posted Date: 2021-09-02

Last Posted Date: 2022-05-18

Lead Sponsor: Cara Therapeutics, Inc.

Registration Number: NCT05031546

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)

Phase 2

Completed

Conditions: Notalgia Paresthetica
Pruritus

Interventions: Drug: difelikefalin 2.0 mg
Drug: Placebo

First Posted Date: 2021-01-13

Last Posted Date: 2023-05-22

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 126

Registration Number: NCT04706975

Locations: 🇨🇦
Cara Therapeutics Study Site, Winnipeg, Canada

Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: CR845 0.5 mcg/kg IV
Other: Placebo
Drug: Moxifloxacin 400 mg Oral Tablet
Drug: CR845 3 mcg/kg IV

First Posted Date: 2019-07-15

Last Posted Date: 2020-02-21

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 57

Registration Number: NCT04019574

Locations: 🇺🇸
Cara Therapeutics Study Site, Dallas, Texas, United States

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis

Phase 2

Completed

Conditions: Pruritus
Atopic Dermatitis

Interventions: Drug: difelikefalin 0.5 mg
Drug: Placebo
Drug: difelikefalin 0.25 mg
Drug: difelikefalin 1.0 mg

First Posted Date: 2019-07-12

Last Posted Date: 2022-04-04

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 401

Registration Number: NCT04018027

Locations: 🇨🇦
Cara Therapeutics Study Site, Montréal, Quebec, Canada
🇺🇸
Cara Therapeutics Study Site 2, Austin, Texas, United States

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Phase 3

Completed

Conditions: Uremic Pruritus

Interventions: Drug: CR845 0.5 mcg/kg

First Posted Date: 2019-06-26

Last Posted Date: 2021-10-15

Lead Sponsor: Cara Therapeutics, Inc.

Target Recruit Count: 222

Registration Number: NCT03998163

Locations: 🇭🇺
Cara Therapeutics Study Site 2, Budapest, Hungary
🇺🇸
Cara Therapeutics Study Site 3, San Antonio, Texas, United States
🇵🇱
Cara Therapeutics Study Site, Sochaczew, Poland

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