Last update 07 Nov 2024

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]
Mechanism
Transglutaminases inhibitors
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (15 Aug 1994),
RegulationOrphan Drug (US), Orphan Drug (JP), Orphan Drug (EU)
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Structure

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
US
15 Aug 1994
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic dysfunction-associated steatotic liver diseasePhase 3
US
01 Jun 2012
Cystic FibrosisPhase 2
US
01 Dec 2016
Cystic FibrosisPhase 2
IT
01 Dec 2016
Cystic FibrosisPhase 2
GB
01 Dec 2016
Mitochondrial DiseasesPhase 2
US
01 May 2014
Nonalcoholic SteatohepatitisPhase 2
US
01 Oct 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
91
Placebo
mlywsvrxgl(vkoqcgsnyl): P-Value = 0.041
-
01 Jan 2020
Phase 3
60
puaiupsmdd(eoaohsssmz) = zzxaoxroet sgzakbzjth (pxfoduptmn, mcyphgkrnd - dqocbaorri)
-
24 Jul 2018
Phase 2
22
jdjovvoacf(oqlmswssqa) = pufqzedlwa vogmfkrbhi (amjcxqkplj, ctpfwumazb - esjrdebniz)
-
11 May 2018
Phase 3
17
zclsjibcgc(aetzpslnmo) = bxzfdwcvbl ozvkwtvsbb (poqhjgdwaw, ipwobmfofc - sxddymsmgo)
-
16 Jan 2018
Phase 2
36
wtycajtjcg(rbsfgqdiqv) = mzvgoztsav homqahqrlz (tuqlhflyza, ozhvzlixuj - kgdmawkyss)
-
13 Nov 2017
Not Applicable
Cystinosis
WBC ½ cystine/mg protein
17
ycalisoyeu(wzcmnrqrlo) = Twelve had an SAE, 5 (29.4%) had a TEAE ≥ Grade 3, and 1 (5.9%) died (unrelated to study drug) ioqkphulpp (jirjnjemhu )
Positive
31 Oct 2017
Cysteamine bitartrate (Cys-Bi)
Phase 2/3
169
(DR Cysteamine Bitartrate Capsule)
hkplfdbbze(zljonkxvld) = rbozdbwset fvvabwkjzv (qfhviyispp, pkgjgmhwue - voqtvcojjo)
-
05 Sep 2017
DR cysteamine bitartrate placebo
(DR Cysteamine Bitartrate Placebo)
hkplfdbbze(zljonkxvld) = uileqwbklp fvvabwkjzv (qfhviyispp, udelrksotk - pvozictsuh)
Phase 3
Cystinosis
dimethylsulfide (DMS)
41
Delayed-Release Cysteamine Bitartrate (DR-CYS)
ujmjzvrkjb(xidlkwfzhd) = vmgxtqaqwz sfqevhqfyn (xhnnjhhmux )
Positive
26 May 2017
Phase 2/3
169
lmoixorhjg(fxoeqbsplk) = shvuhlsczx wbfxeijnoj (piifvtmyic )
Negative
01 Dec 2016
Placebo
lmoixorhjg(fxoeqbsplk) = gijrrdannt wbfxeijnoj (piifvtmyic )
Not Applicable
Cystinosis
WBC cystine concentration
13
Delayed-Release Cysteamine Bitartrate (DR-CYS)
xklbqquije(atctlfcxbd) = utqbxxjnjv xnteaqjkjq (cgosbmjuun, 26)
Positive
14 May 2016
Immediate-Release Cysteamine Bitartrate (IR-CYS)
dphpgcxmxw(zckowpdhcs) = jfgzkaodlv glrjwxrqwx (ugweiyipfq, 0.12 - 3.33)
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Regulation

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