Taurursodiol ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis7

2. Amyotrophic lateral sclerosis


Clinical trials : 624 Drugs : 611 - (DrugBank : 160) / Drug target genes : 172 - Drug target pathways : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05286372
(ClinicalTrials.gov)
April 20229/3/2022An Intermediate Size Expanded Access Protocol of AMX0035 for ALSAn Intermediate Size, Expanded Access Protocol to Provide AMX0035, a Fixed Combination of Sodium Phenylbutyrate (PB) and Taurursodiol (TURSO), for the Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: AMX0035Amylyx Pharmaceuticals Inc.NULLAvailable18 YearsN/AAllNULL
2EUCTR2021-000250-26-PL
(EUCTR)
23/02/202222/11/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;France;Spain;Belgium;Poland;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
3EUCTR2021-000250-26-FR
(EUCTR)
22/11/202125/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;France;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
4EUCTR2021-000250-26-DE
(EUCTR)
27/10/202122/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
5EUCTR2021-000250-26-ES
(EUCTR)
05/10/202123/07/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: fenilbutirato
INN or Proposed INN: Ursodoxicoltaurina
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: Fenilbutirato
INN or Proposed INN: Ursodoxicoltaurina
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Poland;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden
6EUCTR2021-000250-26-NL
(EUCTR)
03/09/202106/07/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Sweden;Italy;United Kingdom;Netherlands;Germany;Ireland;Belgium;Poland;Spain;United States;France;Portugal
7EUCTR2021-000250-26-SE
(EUCTR)
26/08/202128/06/2021A study to investigate the safety and efficacy of AMX0035 in patients with Amyotrophic Lateral SclerosisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients with Amyotrophic Lateral Sclerosis (ALS) - Phoenix ALS (amyotrophic lateral sclerosis)
MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: AMX0035
INN or Proposed INN: phenylbutyrate
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Product Code: AMX0035
INN or Proposed INN: PHENYLBUTYRATE
INN or Proposed INN: Ursodoxicoltaurine
Other descriptive name: taurursodiol
Amylyx Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Spain;Poland;Belgium;Ireland;Netherlands;Germany;United Kingdom;Italy;Sweden