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Copper Histidine

Phase 3

Menkes Disease | Small molecule | Other |Fortress Biotech, Inc.|Last Updated: Nov 19, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

Copper Histidine · 1 trial · 3 indications

Phase 3 1
NCT00811785Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper DeficiencyMenkes Disease
COMPLETED93 Analytics
PHASE3COMPLETED
Molecular Bases of Response to Copper Treatment in Menkes Disease, Related Phenotypes, and Unexplained Copper Deficiency
Menkes DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess neurological improvement in patients with OHS or unexplained copper deficiency treated with subcutaneous CuHis injections.
Three years

Neurological Improvement: reduction in dysautonomia symptoms in OHS, and improved nerve conduction tests in unexplained copper deficiency

Secondary Endpoints

To assess survival in classic Menkes disease subjects treated with subcutaneous CuHis injections in comparison with classic Menkes patients who did not receive any type of copper treatment.
Continuously
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Copper HistidineDRUGDaily subcutaneous injections for three years
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Eligibility Criteria

Age RangeN/A to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision of signed and dated informed consent form by parent or legal guardian, or the subject himself/herself. 2. Male or female, aged 0 to 80 years. 3. Diagnosed...

Countries:United States
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Frequently asked questions about Copper Histidine

What is Copper Histidine used for?

Copper Histidine is an investigational small molecule being studied for the treatment of Menkes Disease, a genetic disorder that affects copper levels in the body. It is also being researched in related conditions such as Occipital Horn Syndrome and unexplained copper deficiency.

Who makes Copper Histidine?

Copper Histidine is being developed by Fortress Biotech, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FBIO. The company is advancing this investigational therapy for Menkes Disease.

What phase is Copper Histidine in?

Copper Histidine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial has been completed, and the drug remains under clinical investigation for Menkes Disease.

What clinical trials is Copper Histidine in?

Copper Histidine has been studied in one completed Phase 3 clinical trial with the identifier NCT00811785. This trial enrolled 93 participants and investigated the molecular bases of response to copper treatment in Menkes Disease, related phenotypes, and unexplained copper deficiency.

Is Copper Histidine the same as copper histidinate?

Copper Histidine is also known as copper histidinate. Both names refer to the same investigational compound being developed by Fortress Biotech for the treatment of Menkes Disease.