Mercaptamine ( DrugBank: Mercaptamine )


1 disease
IDDisease name (Link within this page)Number of trials
19Lysosomal storage disease15

19. Lysosomal storage disease


Clinical trials : 854 Drugs : 716 - (DrugBank : 105) / Drug target genes : 70 - Drug target pathways : 191
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1NCT04125927
(ClinicalTrials.gov)
September 1, 20203/10/2019Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients From 6 Months to Less Than 2 Years OldCystinosisDrug: MercaptamineRecordati Rare DiseasesNULLRecruiting6 Months2 YearsAll5Phase 3France
2EUCTR2018-002984-24-GB
(EUCTR)
25/10/201915/07/2019Open-label, Single-arm, Multicenter Study to Assess the Safety of, Cystadrops® in Pediatric Cystinosis Patients,from 6 Months to Less Than 2 Years Old [SCOB2 Study]Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Than 2 Years Old [SCOB2 Study] - SCOB2 Corneal cystine crystal deposits in pediatric patients withnephropathic cystinosis from 6 months to less than 2 years old;Therapeutic area: Diseases [C] - Eye Diseases [C11]Trade Name: Cystadrops
Product Name: Cystadrops
INN or Proposed INN: Mercaptamine hydrochloride
Other descriptive name: Cysteamine hydrochloride
RECORDATI Rare Diseases SARLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 3United Kingdom;France
3EUCTR2013-003228-35-ES
(EUCTR)
16/07/201412/11/2013Study of the preliminary efficacy and safety of topical cysteamine formulated in viscous solution in cystinosis patientsStudy of the preliminary efficacy and safety of topical cysteamine formulated in viscous solution in cystinosis patients - Viscou solution cysteamina Cystinosis
MedDRA version: 16.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: cysteamine (mercaptamine) viscous solution
INN or Proposed INN: Mercaptamine
Other descriptive name: MERCAPTAMINE HYDROCHLORIDE
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)NULLNot RecruitingFemale: yes
Male: yes
Spain
4EUCTR2012-002773-64-IT
(EUCTR)
12/02/201421/11/2013A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosis - RP103-07 Cystinosis
MedDRA version: 16.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: CYSTAGON
Product Name: Cystagon
INN or Proposed INN: Cystagon
Other descriptive name: Cysteamine bitartrate
Trade Name: CYSTAGON
Product Name: Cystagon
INN or Proposed INN: Cystagon
Other descriptive name: Cysteamine bitartrate
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy
5EUCTR2012-002773-64-GB
(EUCTR)
22/01/201426/02/2013Study comparing the effectiveness of cysteamine bitartrate delayed release capsules (RP103) to Cystagon in Patients with Cystinosis(Adults and Children 12 years and older).A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - Superiority, Safety and Efficacy Study of RP103 in Cystinosis Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 50mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 150mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Netherlands;Germany;Italy;United Kingdom
6EUCTR2012-002773-64-BE
(EUCTR)
21/01/201419/04/2013A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with CystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - RP103-07 Cystinosis
MedDRA version: 14.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 50mg
Product Name: Cystagon
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Trade Name: Cystagon 150mg
Product Name: Cystagon
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Belgium;Netherlands;Germany;United Kingdom;Italy
7EUCTR2012-002773-64-NL
(EUCTR)
15/08/201301/11/2013Study comparing the effectiveness of cysteamine bitartrate delayed-release capsules (RP103) in Patients with Cystinosis (Adult and Children 12 years and older)A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis - Superiority, Safety and Efficacy Study of RP103 in Cystinosis Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate)
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate)
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 50mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon 150mg
Product Name: Cystagon
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Belgium;Germany;Netherlands;Italy;United Kingdom
8EUCTR2012-002773-64-FR
(EUCTR)
03/06/201328/09/2015A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosisA Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-release Capsules (RP103) in Patients withCystinosis - RP103-07 Cystinosis
MedDRA version: 18.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Product Name: Cystagon
INN or Proposed INN: MERCAPTAMINE bitartrate
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Belgium;Netherlands;Italy;United Kingdom
9EUCTR2009-012564-13-FR
(EUCTR)
03/01/201319/06/2013Cysteamine Hydrochloride for nephrOpathic Cystinosis, open-label Phase III pivotal studyCysteamine Hydrochloride for nephropathic Cystinosis, open-label Phase III pivotal study - CYSTADROPS CHOC study Nephropatic cystinosis patients with cystine corneal deposits
MedDRA version: 16.0;Level: LLT;Classification code 10071112;Term: Nephropathic cystinosis;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: CYSTADROPS 0.55% eye drops, solution
INN or Proposed INN: CYSTEAMINE HYDROCHLORIDE
Other descriptive name: Mercaptamine hydrochloride
Orphan Europe SARLNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
10EUCTR2010-018365-34-NL
(EUCTR)
14/12/201006/07/2010A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic CystinosisA Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04 Cystinosis
MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: PROCYSBI
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Horizon Pharma USA, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Netherlands
11EUCTR2009-017882-42-NL
(EUCTR)
19/10/201025/06/2010A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisA Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis Cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
20Netherlands;France
12EUCTR2010-020098-18-FR
(EUCTR)
09/09/201012/07/2010CrYSTobs A cohort of patients with cystinosis : compliance to cysteamine and neurological complicationsAn auxiliary study to Raptor RP103 03 and RP103 04 - CrYSTobsCrYSTobs A cohort of patients with cystinosis : compliance to cysteamine and neurological complicationsAn auxiliary study to Raptor RP103 03 and RP103 04 - CrYSTobs nephropatic cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Trade Name: CYSTAGON
Product Name: CYSTAGON
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
Product Name: RP 103
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
Product Name: RP 103
INN or Proposed INN: MERCAPTAMINE BITARTRATE
Other descriptive name: CYSTEAMINE
HOSPICES CIVILS DE LYONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
13EUCTR2009-017882-42-FR
(EUCTR)
12/08/201014/06/2010A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisA Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic Cystinosis Cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
INN or Proposed INN: mercaptamine bitartrate
Trade Name: Cystagon
Raptor Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
Phase 3France;Netherlands
14EUCTR2007-006024-35-FR
(EUCTR)
04/02/200812/12/2007Adaptive dose regimen of Cystadrops for cOrneal Crystal deposiTs and ocular manifestations in nephropathic cystinosis : an open label, dose-response pilot study - CYSTADROPS OCT-1 pilot studyAdaptive dose regimen of Cystadrops for cOrneal Crystal deposiTs and ocular manifestations in nephropathic cystinosis : an open label, dose-response pilot study - CYSTADROPS OCT-1 pilot study Nephropathic cystinotic patients with cystine crystals corneal deposits
MedDRA version: 9.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders
Product Name: CYSTADROPS
INN or Proposed INN: cysteamine hydrochloride
Other descriptive name: mercaptamine, mercamine, 2-aminoethanethiol
Orphan Europe SARLNULLNot RecruitingFemale: yes
Male: yes
France
15EUCTR2010-018365-34-FR
(EUCTR)
18/06/2010A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis - RP103-04 Cystinosis
MedDRA version: 12.1;Level: LLT;Classification code 10011777;Term: Cystinosis
Product Name: Cysteamine bitartrate (INN: mercaptamine bitartrate )
Product Code: RP103
INN or Proposed INN: mercaptamine bitartrate
Raptor Therapeutics Inc.NULLNAFemale: yes
Male: yes
20Phase 3France;Netherlands