Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Choline Chloride for Injection
Choline Chloride · 1 trial · 2 indications
Cmax = maximum concentration
Tmax = time of maximum concentration
AUC = area under the curve, AUC(0-TAU) = AUC at end of dosing
TEAE = treatment emergent adverse event, TESAE = treatment emergent serious adverse event
Tmax = time of maximum concentration
| Arm | Type | Description |
|---|---|---|
| Open-Label, Dose-Selection: Dose 1 | EXPERIMENTAL | - |
| Open-Label, Dose-Selection: Dose 2 | EXPERIMENTAL | - |
| Open-Label, Dose-Selection: Dose 3 | EXPERIMENTAL | - |
| Double-Blind, Placebo-Controlled: High Dose | EXPERIMENTAL | - |
| Double-Blind, Placebo-Controlled: Low Dose | EXPERIMENTAL | - |
| Double-Blind, Placebo-Controlled: Placebo | PLACEBO_COMPARATOR | - |
| Open Label Extension: High Dose | EXPERIMENTAL | - |
| Open Label Extension: Low Dose | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Choline Chloride for Injection | DRUG | Intravenous use |
| Placebo | DRUG | Intravenous use |
Key Inclusion Criteria: * Male or female 12 years of age or older at the time of signing the informed consent * Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements, prior to study entry * Individuals w...
Choline Chloride is being developed for choline deficiency, including in patients with intestinal failure who receive long term parenteral support. It is an investigational small molecule being studied in a Phase 2 clinical trial. Choline deficiency in this population can be associated with liver injury, which is also listed among the conditions studied.
Choline Chloride is being developed by Protara Therapeutics, Inc., which trades under the ticker TARA. The company is sponsoring the clinical program evaluating the drug in patients with choline deficiency. It holds an orphan drug designation for this program.
Choline Chloride is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The program includes one active Phase 2 trial that is currently recruiting participants, with no completed trials to date.
Choline Chloride is being studied in the Phase 2 trial NCT06910943, titled Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support. The trial is recruiting 129 participants across the United States, Belgium, Denmark, France, Germany, and Poland, and it is randomized, double blind, and placebo controlled.
Yes, Choline Chloride for Injection is another name for Choline Chloride. Both names refer to the same investigational small molecule developed by Protara Therapeutics for choline deficiency. The Phase 2 trial NCT06910943 studies the injectable formulation in adolescent and adult patients with intestinal failure receiving long term parenteral support.
The Phase 2 trial NCT06910943 enrolls adolescent and adult patients with intestinal failure who are receiving long term parenteral support. Participants must be at least 12 years old, and both sexes are eligible. The study does not enroll healthy volunteers and is currently recruiting in the United States and several European countries.