Drugs / trientine
trientine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Wilson disease 1 milestone | |||||
| Filed | US (FDA) | — | Wilson disease | 2021-09-02 | “FDA has accepted for review the Company’s New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease.” orphalan.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Cuprior | — | 2017-09-05 | europa.eu ↗ |
| Approved | US (FDA) | SYPRINE | — | 1985-11-08 | fda.gov ↗ |
Trials 10
| 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| Phase 1 | NCT02068079 | Apr 2014 → Nov 2015 | melanoma | Duke University | Withdrawn | No outcome recorded |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 Stop: Enrollment |
| — | NCT01472874 | Jan 2010 → Jul 2011 | Wilson disease | Yale University | Completed | No outcome recorded |
| Comparator or background therapy4 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 3 | NCT05047523 Comparator | Sep 2021 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03403205 Comparator | Feb 2018 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | Met primary Stop: Business |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-01-18 | Orphalan | Regulatory Orphalan announces China NMPA’s approval of its trientine tetrahydrochloride product for the treatment of Wilson disease orphalan.com ↗
Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialization company, today announces the approval of its trientine tetrahydrochloride product by China’s National Medical Products Administration (NMPA). |
| 2022-09-30 | Orphalan | Results Orphalan announces publication of results from the CHELATE trial in The Lancet Gastroenterology & Hepatology orphalan.com ↗
Using this NCC measurement, TETA-4HCl was determined to be non-inferior to penicillamine at the primary endpoint of the study (24 weeks), with the same observation at the end of the extension phase of the study (one year from randomization) in patients previously receiving maintenance penicillamine therapy. |
| 2022-05-02 | Orphalan | Regulatory Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine orphalan.com ↗
today announces approval of Cuvrior™, a new salt of trientine (trientine tetrahydrochloride) by the United States Food and Drug Administration (FDA). |
| 2021-09-02 | Orphalan | Regulatory FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease orphalan.com ↗
Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease |
| 2021-06-25 | Orphalan | Results Orphalan Announces Positive Top Line Data with Trientine Tetrahydrochloride for Maintenance Patients with Wilson’s Disease orphalan.com ↗
Orphalan today announced positive top line results from a phase 3 head-to-head trial comparing d-Penicillamine with trientine tetrahydrochloride in Wilson’s Disease (WD). |
All press releases naming this drug 5 releases
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 ↗ |