Cysteamine Bitartrate

( DrugBank: Cysteamine / KEGG DRUG: Cysteamine )

4 diseases

ID	Disease name (Link within this page)	Number of trials
8	Huntington disease	1
19	Lysosomal storage disease	16

ID	Disease name (Link within this page)	Number of trials
21	Mitochondrial disease	2
299	Cystic fibrosis	5

8. Huntington disease

Clinical trials : 242 / Drugs : 205 - (DrugBank : 62) / Drug target genes : 85 - Drug target pathways : 159

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2010-019444-39-FR (EUCTR)	18/06/2010	04/05/2010	Essai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HD	Essai multicentrique de traitement de la maladie de Huntington par la cystéamine - CYST-HD	Maladie de Huntington. MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington ...	Product Name: Cysteamine Bitartrate Product Code: RP 103	Centre Hospitalier Universitaire d'Angers	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 2;Phase 3	France

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19. Lysosomal storage disease

Clinical trials : 899 / Drugs : 684 - (DrugBank : 99) / Drug target genes : 51 - Drug target pathways : 182

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04246060 (ClinicalTrials.gov)	July 31, 2020	27/1/2020	Observational Study to Assess the Quality of Life in Nephropathic Cystinosis Patients	Multicentre, Ambispective, Observational, Real Life Study to Assess the Quality of Life Effectivenes ...	Nephropathic Cystinosis	Drug: Cysteamine Bitartrate	Chiesi SA/NV	NULL	Enrolling by invitation	N/A	N/A	All	31		Belgium
2	EUCTR2012-002773-64-IT (EUCTR)	12/02/2014	21/11/2013	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 16.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy
3	EUCTR2012-002773-64-GB (EUCTR)	22/01/2014	26/02/2013	Study comparing the effectiveness of cysteamine bitartratedelayed release capsules (RP103) to Cystag ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Trade Name: PROCYSBI Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate ) Product Code: ...	Horizon Pharma USA, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Netherlands;Germany;Italy;United Kingdom
4	EUCTR2012-002773-64-BE (EUCTR)	21/01/2014	19/04/2013	A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine BitartrateDelayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine BitartrateDelayed-rele ...	Cystinosis MedDRA version: 14.1;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;France;Belgium;Netherlands;Germany;United Kingdom;Italy
5	EUCTR2012-002773-64-NL (EUCTR)	15/08/2013	01/11/2013	Study comparing the effectiveness of cysteamine bitartratedelayed-release capsules (RP103) in Patien ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine BitartrateDelayed-rele ...	Cystinosis MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Trade Name: PROCYSBI Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate) Product Code: R ...	Horizon Pharma USA, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Belgium;Germany;Netherlands;Italy;United Kingdom
6	EUCTR2012-002773-64-FR (EUCTR)	03/06/2013	28/09/2015	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	A Long-Term Open-Label, Safety and Superior Effectiveness Study ofCysteamine Bitartrate Delayed-rele ...	Cystinosis MedDRA version: 18.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate ) Product Code: RP103 INN or Proposed ...	Raptor Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	United States;France;Belgium;Netherlands;Italy;United Kingdom
7	NCT01733316 (ClinicalTrials.gov)	January 31, 2013	16/11/2012	Open-Label, Safety and Superior Effectiveness Study of Cysteamine BitartrateDelayed-Release Capsules ...	A Long-Term, Open-Label, Safety, Tolerability and Superior Effectiveness Study of Cysteamine Bitartr ...	Cystinosis	Drug: RP103;Drug: Cystagon®	Horizon Pharma USA, Inc.	NULL	Completed	12 Years	N/A	All	41	Phase 3	United States;Belgium;France;Italy;Netherlands;United Kingdom
8	NCT01744782 (ClinicalTrials.gov)	December 20, 2012	5/12/2012	Safety/Effectiveness Study of Cysteamine BitartrateDelayed-release Capsules (RP103) in Cysteamine Tr ...	An Open-Label, Safety and Effectiveness Study of Cysteamine BitartrateDelayed-release Capsules (RP10 ...	Cystinosis	Drug: RP103	Horizon Pharma USA, Inc.	NULL	Completed	N/A	6 Years	All	17	Phase 3	United States;Brazil
9	NCT01432561 (ClinicalTrials.gov)	September 2011	9/9/2011	Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the ...	Food-Effect on Bioavailability of Cystagon™ in Normal, Healthy Adults	Cystinosis;Nephropathic Cystinosis	Drug: Cysteamine bitartrate	University of California, San Diego	Raptor Pharmaceuticals Corp.	Completed	18 Years	N/A	All	8	N/A	United States
10	EUCTR2010-018365-34-NL (EUCTR)	14/12/2010	06/07/2010	A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine BitartrateDelayed-release Capsules ...	A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine BitartrateDelayed-release Capsules ...	Cystinosis MedDRA version: 20.0;Level: PT;Classification code 10011777;Term: Cystinosis;System Organ ...	Trade Name: PROCYSBI Product Name: Cysteamine bitartrate(INN: mercaptamine bitartrate ) Product Code: ...	Horizon Pharma USA, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	France;United States;Netherlands

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21. Mitochondrial disease

Clinical trials : 39 / Drugs : 42 - (DrugBank : 32) / Drug target genes : 47 - Drug target pathways : 67

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02473445 (ClinicalTrials.gov)	May 19, 2015	10/6/2015	A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine BitartrateDelayed-r ...	A Long-Term Open-Label Extension Study of RP103-MITO-001 to Assess the Safety, Tolerability and Effi ...	Mitochondrial Diseases	Drug: Cysteamine Bitartrate	Horizon Pharma USA, Inc.	NULL	Terminated	6 Years	17 Years	All	22	Phase 2	United States
2	NCT02023866 (ClinicalTrials.gov)	May 2014	17/12/2013	Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondria ...	An Open-Label, Dose-Escalating Study to Assess the Safety, Tolerability, Efficacy, Pharmacokinetics ...	Inherited Mitochondrial Disease, Including Leigh Syndrome	Drug: Cysteamine Bitartrate	Horizon Pharma USA, Inc.	NULL	Completed	6 Years	17 Years	All	36	Phase 2	United States

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299. Cystic fibrosis

Clinical trials : 1,695 / Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2017-001259-29-GB (EUCTR)	12/03/2019	21/12/2018	A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibr ...	A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) I ...	DeltaF508 Homozygous Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Ter ...	Trade Name: Cystagon Product Name: Cystagon INN or Proposed INN: cysteamine bitartrate Other descriptiv ...	University of LIverpool	NULL	Not Recruiting	Female: yes Male: yes	44	Phase 1;Phase 2	United Kingdom
2	EUCTR2015-004986-99-IT (EUCTR)	11/01/2017	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamine should be ...	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose ...	exacerbation of Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10070608;Term: In ...	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Phase 2	United States;Netherlands;United Kingdom;Italy
3	EUCTR2015-004986-99-GB (EUCTR)	31/10/2016	06/09/2016	A study to identify whether it is safe, if it works, and how much and how often cysteamine should be ...	A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose ...	exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C ...	Product Name: cysteamine bitartrate	NovaBiotics, Ltd	NULL	Not Recruiting	Female: yes Male: yes	120	Phase 2	United States;Netherlands;Italy;United Kingdom
4	EUCTR2014-000284-40-GB (EUCTR)	05/06/2014	29/04/2014	Cysteamine in Cystic Fibrosis	An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults wi ...	Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ...	Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules Product Name: Cystagon (cyste ...	University of Aberdeen	NHS Grampian	Not Recruiting	Female: yes Male: yes	12	Phase 1;Phase 2	United Kingdom
5	EUCTR2013-001258-82-IT (EUCTR)	12/09/2013	29/07/2013	Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutation	A phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR pr ...	Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II ...	Trade Name: Cystagon Product Name: Cysteamine bitartrate (Cystagon) Product Code: EMEA/H/C/000125	European Institute for Cystic Fibrosis Research (IERFC)	NULL	Not Recruiting	Female: yes Male: yes		Phase 2	Italy

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