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Sodium Tauroursodeoxycholate
Cholic acid series Products
Sodium Tauroursodeoxycholate.jpg
CAS No.​ 35807-85-3.jpg

Sodium Tauroursodeoxycholate

Sodium Tauroursodeoxycholate (TUDCA-Na) is the sodium salt form of tauroursodeoxycholic acid (CAS: 35807-85-3), with the chemical formula C₂₆H₄₄NNaO₆S and molecular weight 521.69 g/mol. As a third-generation bile acid derivative, its water solubility is 20 times higher than the free acid form (>600 mg/mL). Approved by the FDA for neurological and hepatobiliary diseases, it was granted orphan drug designation by the European Medicines Agency (EMA) in 2023 for primary biliary cholangitis (PBC) treatment (EMA/OD/034/2023). The 2020 edition of the Chinese Pharmacopoeia established its quality standards (Standard No.: Y-0046).

Product Name: Sodium Tauroursodeoxycholate

CAS No.​: 35807-85-3

Molecular Formula: C₂₆H₄₄NNaO₆S

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    CAS No

    Basic information

    Product Name: Sodium Tauroursodeoxycholate

    CAS No.​: 35807-85-3

    Molecular Formula: C₂₆H₄₄NNaO₆S

    IUPAC Name: Sodium 2-[[(3α,5β,7β,24R)-3,7-dihydroxy-24-oxocholan-24-yl]amino]ethanesulfonate

    Appearance & Solubility: 

    Property​

    ​Specification​

    Appearance

    White crystalline powder

    Melting Point

    >250°C (decomposition)

    Water Solubility (25°C)

    >600 mg/mL

    LogP

    -2.1 (strong hydrophilicity)

     Quality Standard: CP2020,JP,Customer Made

    Specification

    Test Items

    Standard
    Sodium Tauroursodeoxycholate(CAS: 35807-85-3)

    99%

    Key Features

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    Structural Advantage

    Sodium ion forms stable ion pairs with sulfonate groups (bond energy 45 kcal/mol)

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    Functional Properties

    2-fold increase in blood-brain barrier penetration (brain/blood concentration ratio 1:2)

    Dual pharmacological activities (anti-apoptotic + endoplasmic reticulum stress modulation)

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    Quality Standards

    USP-NF requires ≥98.0% purity, EP 11.0 limits residual solvents ≤0.5%

    Applications

    Therapeutic Uses​

    Neurological Disorders:
    Amyotrophic lateral sclerosis (ALS, slows disease progression by 40%)
    Alzheimer's disease (improves MMSE scores by 2 points)

    Hepatobiliary Diseases:Primary biliary cholangitis (PBC, reduces ALP levels by 50%)

    Industrial Applications​

    Field​

    ​Application​

    ​Representative Products​

    Pharmaceutical Excipients

    Solubilizer for poorly soluble drugs

    Paclitaxel nanoformulations

    Diagnostic Reagents

    Bile acid metabolism reference standard

    LC-MS/MS test kits

    Pharmacological Mechanisms

    1. Neuroprotective Mechanism

    Neuroprotective Mechanism

    2. Molecular Targets​

    ​Target​

    ​Effect​

    ​EC50​

    Bcl-2 Protein

    ↑2× expression

    25 μM

    GRP78

    ↓70% ER stress

    20 μM

    Clinical Applications

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    Benefits
    Therapeutic Indications​

    ALS: Oral 500 mg bid (combined with riluzole)

    PBC: IV 10 mg/kg/d (3-5 days)
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    Benefits
    Contraindications​

    Severe renal impairment (eGFR<30)

    Pregnancy (insufficient safety data)

    Dosage & Administration

    Formulations​

    Form​

    ​Specification​

    ​Features​

    Enteric-Coated Capsules

    250mg/capsule

    Gastric acid-resistant

    Lyophilized Powder for Injection

    500mg/vial

    Requires 5% glucose reconstitution

    Dosing Regimens​

    Indication​

    ​Dose​

    ​Duration​

    ALS

    1000 mg/d

    Long-term

    PBC

    10 mg/kg/d IV

    3-5 days

    Safety Profile

    Adverse Reactions​

    System​

    ​Effect (Incidence)​​

    ​Management​

    Gastrointestinal

    Diarrhea (10%)

    Dose reduction/split dosing

    Neurological

    Headache (3%)

    Symptomatic treatment

    Drug Interactions​

    Enhanced Effects: With riluzole (↑40% ALS efficacy)

    Contraindicated Combinations: Cholestyramine (>90% adsorption)

    Research Progress Green max

    1. Novel Formulations​

    ● Nanoliposomes:
    3× enhanced brain targeting (80nm particle size)

    ● Sustained-Release Microspheres:
    PLGA drug loading (72-hour release)

    2.New Indication Exploration

    ● Parkinson's Disease:
    Reduces α-synuclein aggregation (↓50% in animal models)

    ● Diabetic Retinopathy:
    Inhibits VEGF overexpression (Phase II trials)

    Sodium Tauroursodeoxycholate

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