Drugs / TETA 4HCL
TETA 4HCL
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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)” orphalan.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07465718 | Sep 2026 → Feb 2028 expected | Wilson disease | Orphalan | Recruiting | No outcome recorded |
| Phase 3 | NCT03539952 | Sep 2018 → Aug 2020 | Wilson disease | Orphalan | Completed | Met primary |
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 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TETA 4HCL | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03539952 ↗ |
| Known as | TETA4 | “We aimed to compare penicillamine with trientine tetrahydrochloride (TETA4) for maintenance therapy in patients with Wilson disease.” PMID 36183738 ↗ Sep 2022 |
| Known as | trientine tetrahydrochloride | “A new formulation of trientine tetrahydrochloride (TETA 4HCl) has been developed to be administered once a day.” NCT07465718 ↗ |
| Route | Oral | “switched mg-for-mg to oral TETA4” PMID 36183738 ↗ Sep 2022 |