Drugs / trientine
trientine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cuprior | — | 2017-09-05 | europa.eu ↗ |
| Approved | US (FDA) | SYPRINE | — | 1985-11-08 | fda.gov ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06128954 | Jan → Feb 2024 | Wilson disease | Orphalan | Completed | No outcome recorded |
| Phase 1 | NCT02068079 | Apr 2014 → Nov 2015 | melanoma | Duke University | Withdrawn | No outcome recorded |
| Phase 1 | NCT01874028 | May 2013 → Mar 2014 | Wilson disease | Univar BV | Completed | No outcome recorded |
| Phase 1 | NCT01178112 | Jul 2010 → Aug 2014 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03480750 | Sep 2012 → Oct 2015 | fallopian tube cancer, ovarian cancer, peritoneal carcinoma | National Cheng-Kung University Hospital | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07010575 | Jul → Dec 2025 | Wilson disease | Orphalan | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00004339 | Jan 1994 → ? | Wilson disease | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02426905 | Jan 2016 → May 2018 | Wilson disease | Univar BV | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01213888 | Nov 2010 → Apr 2013 | diabetic retinopathy | University of British Columbia | Terminated | No outcome recorded |
| — | NCT01472874 | Jan 2010 → Jul 2011 | Wilson disease | Yale University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04706429 Comparator | Dec 2020 → Apr 2024 | hypertrophic cardiomyopathy | Manchester University NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT01295073 Comparator | — | macular retinal edema | University of British Columbia | Withdrawn | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05047523 Comparator | Sep 2021 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT03403205 Comparator | Feb 2018 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trientine | “This is a single centre, phase I, randomized, controlled trial with a crossover design to evaluate the pharmacokinetics (PK), safety, and tolerability of a new once daily TETA...” NCT06128954 ↗12“Depending on the site/region, participants randomized to receive Standard of Care treatment will receive trientine, penicillamine, zinc, or a combination of these medicines,...” NCT05047523 ↗ “Depending on the site/region, participants randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered...” NCT03403205 ↗ “Each film-coated tablet contains 300 mg of trientine base.” NCT07010575 ↗ |
| Known as | TETA-2HCl | “Trientine dihydrochloride (TETA-2HCl) is approved for the treatment of Wilson disease in patients (≥ 5 years) intolerant to D-penicillamine therapy.” PMID 40104015 ↗ Mar 2025 |
| Known as | Trientine dihydrochloride | “Trientine dihydrochloride is a copper-chelating agent licensed for Wilson disease, a genetic disorder of copper excretion, in which patients exhibit a cardiac phenotype that mimics HCM.” NCT04706429 ↗1“Trientine dihydrochloride (TETA-2HCl) is approved for the treatment of Wilson disease in patients (≥ 5 years) intolerant to D-penicillamine therapy.” PMID 40104015 ↗ Mar 2025 |
| Known as | Trientine Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01295073 ↗ |
| Route | Oral | “Starting on Day 1 of Cycle 1, you will begin taking trientine by mouth several times each day.” NCT01178112 ↗ |