difelikefalin
Trade name: Korsuva
Small moleculeapprovedBreakthrough Therapy FDA
Approved
Aug 23, 2021
Difelikefalin, sold under the brand name Korsuva, is an opioid peptide used for the treatment of moderate to severe itch. It acts as a peripherally-restricted, highly selective agonist of the κ-opioid receptor (KOR). — Wikipedia
Clinical trial activity
29 trials · 8 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
21
Phase 3
12
Phase 4
0
Earliest trial started Mar 1, 2009 (NCT00877799)
Timeline
2000s
- Jan 1, 2009
Cara Therapeutics — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2017
Cara Therapeutics — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2019
Cara Therapeutics — Earliest Phase 1 Sponsor(trial)
2020s
- Aug 23, 2021
Cara Therapeutics — Earliest FDA Approval
- Aug 23, 2021
Cara Therapeutics — Marketing Organization
- Aug 23, 2021
Cara Therapeutics — NDA Secondary Org
- Aug 23, 2021
Cara Therapeutics — NDA Organization
Indications
Studied for
- Abdominal Pain · Phase 2/Phase 3
- Acute Pain · Phase 2
- Arthritis · Phase 2
- Dermatitis, Atopic · Phase 3
- Healthy Volunteers · Phase 1
- Joint Diseases · Phase 2
- Kidney Failure, Chronic · Phase 1
- Musculoskeletal Diseases · Phase 2
- Osteoarthritis · Phase 2
- Osteoarthritis, Hip · Phase 2
- Osteoarthritis, Knee · Phase 2
- Paresthesia · Phase 2/Phase 3
- Postoperative Pain · Phase 2
- Pruritus · Phase 3
- Renal Dialysis · Phase 1
- Renal Insufficiency, Chronic · Phase 3
- Rheumatic Diseases · Phase 2
Mechanism of action
- Kappa opioid receptorAGONIST
OPRK1 agonist
Approval history
- approvedPriority reviewBreakthroughAug 23, 2021
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H](N)Cc1ccccc1)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(C(=O)O)CC1- Mol. weight
- 679.86 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaDifelikefalin ↗
- ChEMBLCHEMBL5315123 ↗
- ChEMBLCHEMBL3989915 ↗
Also known as
- cr845
- cr845
- difelikefalin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06593392 | Phase 2 | Jan 31, 2025 | Fresenius |
| NCT05978063 | Phase 2/Phase 3 (Phase 3) | Aug 1, 2023 | Cara Therapeutics |
| NCT05885763 | Phase 1 | Jun 26, 2023 | Fresenius, Tigermed Consulting Co., Ltd, Vifor Inc. |
| NCT05885737 | Phase 3 | May 30, 2023 | Fresenius, Tigermed Consulting Co., Ltd, Vifor Inc. |
| NCT05356403 | Phase 3 | Aug 26, 2022 | Cara Therapeutics |
| NCT05387707 | Phase 3 | Aug 16, 2022 | Cara Therapeutics |
| NCT05342623 | Phase 3 | May 17, 2022 | Cara Therapeutics |
| NCT04711603 | Phase 3 | Jan 16, 2021 | Kissei Pharmaceuticals |
| NCT04706975 | Phase 2 | Jan 11, 2021 | Cara Therapeutics |
| NCT05533008 | Phase 1 | Dec 31, 2019 | Cara Therapeutics |
| NCT04018027 | Phase 2 | Jul 31, 2019 | Cara Therapeutics |
| NCT03995212 | Phase 2 | Jun 30, 2019 | Cara Therapeutics |
| NCT04019574 | Phase 1 | Jun 20, 2019 | Cara Therapeutics |
| NCT03998163 | Phase 3 | May 6, 2019 | Cara Therapeutics |
| NCT03802617 | Phase 2 | Feb 28, 2019 | Kissei Pharmaceuticals, Maruishi Pharmaceutical |
| NCT03947970 | Phase 1 | Jan 17, 2019 | Cara Therapeutics |
| NCT03636269 | Phase 3 | Jul 17, 2018 | Cara Therapeutics |
| NCT03617536 | Phase 2 | Jul 5, 2018 | Cara Therapeutics |
| NCT03422653 | Phase 3 | Feb 20, 2018 | Cara Therapeutics |
| NCT03281538 | Phase 3 | Aug 14, 2017 | Cara Therapeutics |
Showing 20 of 29 trials
Page 1 / 2
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Cara Therapeutics | For profit | 24 | 24 | 4 | 2009 |
| Fresenius | For profit | 3 | 3 | 3 | 2023 |
| Kissei Pharmaceuticals | For profit | 2 | 2 | 2 | 2019 |
| Tigermed Consulting Co., Ltd | For profit | 2 | 0 | 2 | 2023 |
| Vifor Inc. | For profit | 2 | 0 | 2 | 2023 |
| Duke University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Jean Brown Research | For profit | 1 | 0 | 1 | 2013 |
| Maruishi Pharmaceutical | For profit | 1 | 0 | 1 | 2019 |
8 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Cara Therapeutics | For profit | MKTG | Aug 23, 2021 |
| Cara Therapeutics | For profit | NDA2 | Aug 23, 2021 |
| Cara Therapeutics | For profit | NDA | Aug 23, 2021 |