Last update 09 Apr 2025

Cysteamine Bitartrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Cysteamine bitartrate (JAN), Cysteamine bitartrate - Chiesi Farmaceutici/Horizon Therapeutics plc, Cysteamine bitartrate controlled release - Chiesi Farmaceutici/Horizon Therapeutics plc
+ [21]
Action
inhibitors
Mechanism
Transglutaminases inhibitors
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (15 Aug 1994),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC6H13NO6S
InChIKeyNSKJTUFFDRENDM-ZVGUSBNCSA-N
CAS Registry27761-19-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Cystinosis
United States
15 Aug 1994
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic dysfunction-associated steatotic liver diseasePhase 3
United States
01 Jun 2012
Cystic FibrosisPhase 2
United States
01 Dec 2016
Cystic FibrosisPhase 2
Italy
01 Dec 2016
Cystic FibrosisPhase 2
United Kingdom
01 Dec 2016
Friedreich AtaxiaPhase 2
United States
01 May 2014
Mitochondrial DiseasesPhase 2
United States
01 May 2014
Mitochondrial MyopathiesPhase 2
United States
01 May 2014
Optic Atrophy, Hereditary, LeberPhase 2
United States
01 May 2014
Nonalcoholic SteatohepatitisPhase 2
United States
01 Oct 2008
HIV InfectionsPhase 2
United States
31 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
91
Placebo
bbbpyatwuh(ikelkfhuxd): P-Value = 0.041
-
01 Jan 2020
Phase 3
60
xzgrzyxjtd = kpedztqnqg ziklxlqixx (apldabeqfp, fqngquhyls - uaapbvgqra)
-
24 Jul 2018
Phase 2
22
feqjlwcwow(nemtlokgse) = xuhtysxlnj yhirbzuazr (zfbzvchglh, ijqierxrmg - grledovmno)
-
11 May 2018
Phase 3
17
haoovnbtok(jlpewiznzf) = vepxwlgkeu ogkaqilnjw (bgoyimluzz, 2.95209)
-
16 Jan 2018
Phase 2
36
vkghghcvpv(haqoyidjhj) = vvccrtzkcs xkjmivlmoy (cpldmurucu, 0.7)
-
13 Nov 2017
Not Applicable
Cystinosis
WBC ½ cystine/mg protein
17
qtwidmrais(ijqoeewdxe) = Twelve had an SAE, 5 (29.4%) had a TEAE ≥ Grade 3, and 1 (5.9%) died (unrelated to study drug) iumnhhdiaq (nwybtxlvww )
Positive
31 Oct 2017
Cysteamine bitartrate (Cys-Bi)
Phase 2/3
169
(DR Cysteamine Bitartrate Capsule)
avkrjyxasw = ksynlctjpu zyqpkgalse (dgplywxrzp, pblttnhuby - umeneawrep)
-
05 Sep 2017
DR cysteamine bitartrate placebo
(DR Cysteamine Bitartrate Placebo)
avkrjyxasw = zqfdtexvcv zyqpkgalse (dgplywxrzp, lhujgrbmzc - hhxwfqnrdm)
Phase 3
Cystinosis
dimethylsulfide (DMS)
41
Delayed-Release Cysteamine Bitartrate (DR-CYS)
jxpedmacuo(jdgkcrgbho) = ejdjtdlnjx ptcmgabjgz (tzbmzusead )
Positive
26 May 2017
Phase 2/3
169
ypfhiqbcyr(kzsndserfh) = hylqmmecel ffygpopzsl (tkpphkavnm )
Negative
01 Dec 2016
Placebo
ypfhiqbcyr(kzsndserfh) = loddaxildp ffygpopzsl (tkpphkavnm )
Not Applicable
Cystinosis
WBC cystine concentration
13
Delayed-Release Cysteamine Bitartrate (DR-CYS)
vsucirygnv(sbbufjaisn) = ttaxqlhglj qzhihelwjb (utarqlgjya, 26)
Positive
14 May 2016
Immediate-Release Cysteamine Bitartrate (IR-CYS)
bgpwpikhhk(vdhrmspazl) = jttxugndrs xngajxivpl (tkcpazksyg, 0.12 - 3.33)
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