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Choline Chloride

Phase 2

Choline Deficiency | Small molecule | Gastrointestinal |Protara Therapeutics, Inc.|Last Updated: May 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment129
FDA Designations
FAST_TRACKORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06910943Study of Choline Chloride for Injection in Adolescent and Adult Patients With Intestinal Failure Receiving Long Term Parenteral SupportPHASE2 RECRUITING 129 — — Dec 10, 2025Jun 1, 2028May 15, 202617 United States, Belgium +4
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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 — 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)
LOWMay 26, 2026NCT06910943primaryCompletionDate: changed
LOWMay 24, 2026NCT06910943studyFirstPostDate: changed