Drugs / Nalfurafine
Nalfurafine
also known as
Nalfurafine Hydrochloride · TRK-820 · AC-820 · MT-9938 · Nalfurafina · Nalfurafine HCl · Nopicor · Remitch
Small molecule targets OPRK1 via activation
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03002233 | Nov 2016 → Jul 2017 | — | Toray Industries, Inc | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00638495 | Mar 2008 → Dec 2009 | — | Toray Industries, Inc | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04728984 | Sep 2020 → Jun 2021 | — | Shenyang Sunshine Pharmaceutical Co., LTD. | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07650851 | Jul 2026 → Dec 2028 expected | — | Chinese PLA General Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07098351 | Aug 2025 → Jun 2027 expected | chronic kidney disease | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT01248650 Comparator | Dec 2008 | chronic renal failure syndrome | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01660243 Comparator | Sep 2012 → Mar 2014 | — | Toray Industries, Inc | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00793156 Comparator | Dec 2009 → Dec 2010 | — | Acologix, Inc. | Unknown | No outcome recorded |
| Phase 3 | NCT01513161 Comparator | Apr 2008 → Oct 2009 | — | SK Chemicals Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT07380113 Comparator | Jul 2026 → Dec 2027 expected | chronic kidney disease, uremia | Zhujiang Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-09-25 | Toray Industries, Inc | Regulatory Indonesian Regulator Approves REMITCH<sup>®</sup> OD Tablets 2.5µg for Pruritus Relief toray.com ↗
Tokyo, Japan, September 26, 2024 – Toray Industries, Inc., and Meiji Seika Pharma Co., Ltd., announced today that PT. Meiji Indonesian Pharmaceutical Industries, a subsidiary of the latter company, obtained regulatory approval in August, to import and market REMITCH® OD Tablets 2.5µg (generic name: nalfurafine hydrochloride; see note below) in Indonesia. |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nalfurafine | “Nalfurafine 2.5μg daily for 2 weeks.” NCT07098351 ↗ |
| Known as | AC-820 | “A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)” NCT00793156 ↗ |
| Known as | MT-9938 | “Nalfurafine hydrochloride(MT-9938) 2.5μg” NCT01660243 ↗ |
| Known as | Nalfurafina | ChEMBL registry synonym — accepted as the source's own label CHEMBL267495 ↗ |
| Known as | Nalfurafine HCl | “A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)” NCT00793156 ↗ |
| Known as | Nalfurafine Hydrochloride | “Nalfurafine hydrochloride orally disintegrating tablets will be took at a dose of 2.5μg (1 tablet) once daily for 12 consecutive weeks.” NCT07650851 ↗3“Nalfurafine Hydrochloride Orally Disintegrating Tablets” NCT07098351 ↗ “Nalfurafine hydrochloride(MT-9938) 2.5μg” NCT01660243 ↗ “Nalfurafine Hydrochloride (TRK-820)” NCT00638495 ↗ |
| Known as | Nopicor | ChEMBL registry synonym — accepted as the source's own label CHEMBL267495 ↗ |
| Known as | Remitch | ChEMBL registry synonym — accepted as the source's own label CHEMBL267495 ↗ |
| Known as | TRK-820 | “Drug: nalfurafine hydrochloride (TRK-820)” NCT01513161 ↗ |
| Action | Activate | “Kappa opioid agonists, including nalfurafine also reduced itch in this population” PMID 33283264 ↗ Dec 20201“Kappa opioid receptor agonist” CHEMBL267495 ↗ |
| Modality | Small molecule | — CHEMBL267495 ↗ |
| Route | Oral | “administered orally once daily” NCT00638495 ↗ |
| Target | OPRK1 | “Kappa opioid receptor agonist” CHEMBL267495 ↗ |