Drugs / penicillamine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CUPRIMINE | — | 1970-12-04 | fda.gov ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03957720 | Mar 2019 → Dec 2024 | Wilson disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT06103617 | Nov 2023 → Oct 2024 | head and neck cancer | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT00003751 | Mar 1999 → Jun 2004 | central nervous system neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | Missed primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03539952 | Sep 2018 → Aug 2020 | Wilson disease | Orphalan | Completed | Met primary |
| Phase not stated1 trial | ||||||
| — | NCT01374282 | — | scleroderma | Merck Sharp & Dohme LLC | No longer available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| 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 · 2
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 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 3 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | penicillamine | “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 ↗6“Depending on the site/region, participants randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered...” NCT03403205 ↗ |
| Known as | Cuprimine | “Cuprimine (penicillamine)” NCT01374282 ↗ |
| Route | Oral | “Patients receive oral penicillamine on the following schedule:” NCT00003751 ↗ |