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ORPHALAN

🇫🇷France
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

8

Active:4
Completed:2

Trial Phases

3 Phases

Phase 1:4
Phase 2:1
Phase 3:1

Drug Approvals

2

NMPA:1
EMA:1

Drug Approvals

Trientine Hydrochloride Tablets

Product Name
盐酸曲恩汀片
Approval Number
国药准字HJ20230149
Approval Date
Dec 29, 2023
NMPA

Clinical Trials

Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials

Phase 1
4 (66.7%)
Phase 2
1 (16.7%)
Phase 3
1 (16.7%)

Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride

Phase 2
Not yet recruiting
Conditions
Wilson's Disease
Interventions
Drug: New TETA 4HCl Formulation
Drug: Standard of Care
First Posted Date
2025-06-08
Last Posted Date
2025-07-03
Lead Sponsor
Orphalan
Target Recruit Count
10
Registration Number
NCT07010575

Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).

Phase 1
Completed
Conditions
Wilson's Disease
Interventions
Drug: 900mg TETA 4HCl Once Daily Formulation
Drug: 900mg TETA 4HCl Cuprior®
First Posted Date
2023-11-13
Last Posted Date
2024-06-25
Lead Sponsor
Orphalan
Target Recruit Count
24
Registration Number
NCT06128954
Locations
🇬🇧

Richmond Pharmacology Ltd, London, United Kingdom

Real World Evidence Study in Subjects With Wilson's Disease

Active, not recruiting
Conditions
Wilson Disease
First Posted Date
2023-03-24
Last Posted Date
2025-07-03
Lead Sponsor
Orphalan
Target Recruit Count
50
Registration Number
NCT05783687
Locations
🇺🇸

UC Davis Midtown Ambulatory Care Centre, Sacramento, California, United States

🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

🇺🇸

University of Miami, Miami, Florida, United States

and more 6 locations

International Wilson's Disease Patient Registry (iWilson Registry)

Recruiting
Conditions
Wilson's Disease
First Posted Date
2022-02-15
Last Posted Date
2025-07-03
Lead Sponsor
Orphalan
Target Recruit Count
500
Registration Number
NCT05239858
Locations
🇧🇪

University Hospital Leuven, Leuven, Belgium

🇫🇷

Hospices Civils de Lyon, Bron, Auvergne-Rhone-Alpes, France

🇫🇷

HF Adolphe de Rothschild, Paris, Île-de-France, France

and more 13 locations

Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease

First Posted Date
2018-05-30
Last Posted Date
2025-07-02
Lead Sponsor
Orphalan
Target Recruit Count
77
Registration Number
NCT03539952
Locations
🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

🇧🇪

KU Leuven, Department of Clinical and Experimental Medicine, Leuven, Belgium

🇧🇷

Hospital Nossa Senhora das Graças (HNSG), Curitiba, Brazil

and more 12 locations

News

Orphalan Makes History as First European Company to Enter China's Wilson Disease Market with "Ke Pei Ou"

• Orphalan has launched trientine tetrahydrochloride ("Ke Pei Ou") in China through a strategic partnership with SPH Kyuan Trade, becoming the first European company to introduce an orphan drug for Wilson disease in this market. • The treatment addresses a critical unmet need for Chinese Wilson disease patients who cannot tolerate penicillamine, the previous standard therapy, offering an alternative that is already available in over 20 countries globally. • Orphalan has established a local entity in Shanghai led by Grace Li as General Manager, demonstrating its commitment to ensuring Chinese patients and healthcare providers have access to advanced Wilson disease treatment options.

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