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Choline Chloride

Phase 2

Choline Deficiency | Small molecule | Gastrointestinal |Protara Therapeutics, Inc.|Last Updated: Jun 29, 2026

Target and mechanism

ModalitySmall molecule

Also known as Choline Chloride for Injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment129

FDA Designations

FAST_TRACKORPHAN_DRUG

Clinical trial landscape

Choline Chloride · 1 trial · 2 indications

Phase 2 1
NCT06910943Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral SupportCholine Deficiency
RECRUITING129 Analytics
PHASE2RECRUITING
Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral Support
Choline Deficiency
NCT06910943129
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Study Endpoints

Primary Endpoints

Open-Label Dose-Selection Phase: PK of plasma free choline (Cmax) during Week 1 and Week 8 Visits
Week 1 to Week 8

Cmax = maximum concentration

Open-Label Dose-Selection Phase: Open-Label Dose-Selection Phase: PK of plasma free choline (Tmax) during Week 1 and Week 8 Visits
Week 1 to Week 8

Tmax = time of maximum concentration

Open-Label Dose-Selection Phase: PK of plasma free choline (AUC(0-TAU)) during Week 1 and Week 8 Visits
Week 1 to Week 8

AUC = area under the curve, AUC(0-TAU) = AUC at end of dosing

Open-Label Dose-Selection Phase: Change from Baseline in plasma free choline concentrations at Week 8
Week 1 to Week 8
Open-Label Dose-Selection Phase and Double-Blind, Placebo-Controlled Phase, Open-Label Extension Phase: Incidence and severity of TEAEs Incidence of TESAEs
Week 1 to Week 64

TEAE = treatment emergent adverse event, TESAE = treatment emergent serious adverse event

Double-Blind, Placebo-Controlled Phase: Change from Baseline in peak plasma free choline concentrations (Cmax) at Week 8 in participants receiving Choline Chloride for Injection versus Placebo
Week 1 to Week 8

Tmax = time of maximum concentration

Open-Label Extension Phase: Participants from Open-Label Dose-Selection Phase: Percentage of participants with plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 64
Week 64
Open-Label Extension Phase: Percentage of participants maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8 and Week 64 (ie, both timepoints)
Week 8 to Week 64
Open-Label Extension Phase: Participants from Double-Blind, Placebo-Controlled Phase: % with plasma free choline concentrations of ≥9.5 nmol/mL at Week 64
Week 1 to Week 64
Open-Label Extension Phase: Participants from Double-Blind Placebo-Controlled Phase: % maintaining plasma free choline concentrations of ≥ 9.5 nmol/mL at Week 8, Week 24 and Week 64 for participants who previously received Choline Chloride for Injection
Week 8 to Week 64

Secondary Endpoints

Open-Label Dose-Selection Phase: Change from Baseline to Week 8 in ALP, AST, ALT, GGT, VLDL, total bilirubin, direct bilirubin levels, CPK, homocysteine and albumin levels
Week 1 to Week 8
Open-Label Dose-Selection Phase: Triplicate QTc measurements collected during Week 1 and Week 8, and changes from pre-infusion QTc at Week 1 to all post-baseline timepoints
Week 1 to Week 8
Open-Label Dose-Selection Phase: Percentage of participants achieving plasma free choline concentration Cmax ≥ 9.5 nmol/mL at Week 8
Week 1 to Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Open-Label, Dose-Selection: Dose 1EXPERIMENTAL -
Open-Label, Dose-Selection: Dose 2EXPERIMENTAL -
Open-Label, Dose-Selection: Dose 3EXPERIMENTAL -
Double-Blind, Placebo-Controlled: High DoseEXPERIMENTAL -
Double-Blind, Placebo-Controlled: Low DoseEXPERIMENTAL -
Double-Blind, Placebo-Controlled: PlaceboPLACEBO_COMPARATOR -
Open Label Extension: High DoseEXPERIMENTAL -
Open Label Extension: Low DoseEXPERIMENTAL -

Interventions

NameTypeDescription
Choline Chloride for InjectionDRUGIntravenous use
PlaceboDRUGIntravenous use
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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...

Countries:United StatesBelgiumDenmarkFranceGermanyPoland
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Recent Changes (Last 90 Days)

LOWJun 29, 2026NCT06910943lastUpdatePostDate: changed
LOWJun 29, 2026NCT06910943lastUpdatePostDate: changed
LOWMay 26, 2026NCT06910943primaryCompletionDate: changed
LOWMay 24, 2026NCT06910943studyFirstPostDate: changed

Frequently asked questions about Choline Chloride

What is Choline Chloride used for?

Choline Chloride is an investigational small molecule being developed for choline deficiency, specifically in adolescent and adult patients with intestinal failure receiving long term parenteral support. It is also being studied for liver injury associated with this condition. The drug is currently in Phase 2 clinical development.

What does Choline Chloride target?

Choline Chloride is a form of choline, an essential nutrient. It works by providing choline to patients who cannot obtain it through normal dietary intake due to intestinal failure. This helps address choline deficiency and related liver injury in patients on long term parenteral support.

Who makes Choline Chloride?

Choline Chloride is being developed by Protara Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TARA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with choline deficiency.

What phase is Choline Chloride in?

Choline Chloride is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Fast Track and Orphan Drug designations from the FDA for its intended use.

What clinical trials is Choline Chloride in?

Choline Chloride is being studied in a Phase 2 clinical trial with the identifier NCT06910943. This randomized, double-blind, placebo-controlled trial is recruiting 129 participants across the United States, Belgium, Denmark, France, Germany, and Poland. The study is evaluating the drug in patients aged 12 years and older with choline deficiency and liver injury.

Is Choline Chloride the same as Choline Chloride for Injection?

Yes, Choline Chloride is also known as Choline Chloride for Injection. Both names refer to the same investigational drug being developed by Protara Therapeutics for the treatment of choline deficiency in patients with intestinal failure receiving long term parenteral support.