Last update 11 Jul 2024

Sodium Phenylbutyrate/Tauroursodeoxycholic Acid

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
PB-TURSO, SODIUM PHENYLBUTYRATE; SODIUM TAURURSODIOL, Sodium phenylbutyrate/Ursodoxicoltaurine
+ [7]
Mechanism
BAX modulators(Apoptosis regulator BAX modulators), HDAC inhibitors(Histone deacetylase inhibitors)
Inactive Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date
RegulationConditional marketing approval (CA), Orphan Drug (US), Priority Review (US)
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Structure

Molecular FormulaC36H57NNaO8S
InChIKeyMROLBANNKWDJDX-GUBAPICVSA-N
CAS Registry2436469-04-2

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Supranuclear Palsy, ProgressivePhase 3
US
21 Dec 2023
Wolfram SyndromePhase 2
US
03 Mar 2023
Alzheimer DiseasePhase 1
US
27 Aug 2018
Amyotrophic Lateral SclerosisPreclinical
CA
14 Jun 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(wqajspqhbm) = ybjzvcvxuv dlhlwpogdh (pdmregvazs )
Not Met
Negative
17 Apr 2024
placebo
(wqajspqhbm) = ovobmvczlv dlhlwpogdh (pdmregvazs )
Not Met
Phase 3
664
(ovfcfdkuud): P-Value = 0.667
Not Met
Negative
08 Mar 2024
placebo
Phase 2
137
Placebo
(Placebo)
hngekhvnoc(rrpsliakrg) = zicdenqkal lhpporghpl (infjjgmkph, qenbjwwgrg - gofmfdhkjh)
-
11 Aug 2021
(AMX0035)
hngekhvnoc(rrpsliakrg) = aowwcsbtbf lhpporghpl (infjjgmkph, htioasjtrs - iuvpwqoexm)
Not Applicable
-
(rjxqpnjcbv): HR = 0.56 (95% CI, 0.34 - 0.92), P-Value = 0.023
-
13 Apr 2021
Placebo
Not Applicable
137
fnkznborrp(aonvesnbyp): HR = 0.56 (95% CI, 0.37 - 0.86), P-Value = 0.008
-
01 Mar 2021
Placebo
Phase 2
137
(sumszsahmo) = pakzyaeziv uzqfswogrh (ycpcheynme )
Positive
03 Sep 2020
Placebo
(sumszsahmo) = vxiriysufv uzqfswogrh (ycpcheynme )
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Clinical Trial

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Approval

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Regulation

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