Last update 21 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 (JP)
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Structure

Molecular FormulaC2H7NS
InChIKeyUFULAYFCSOUIOV-UHFFFAOYSA-N
CAS Registry60-23-1
View All Structures (2)

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
Cystic FibrosisPhase 3
GB
01 Dec 2016
Cystic FibrosisPhase 3
IT
01 Dec 2016
Cystic FibrosisPhase 3
US
01 Dec 2016
Mitochondrial DiseasesPhase 3
US
01 May 2014
Metabolic dysfunction-associated steatotic liver diseasePhase 3
US
01 Jun 2012
CystinosisPhase 3
FR
01 Jun 2010
CystinosisPhase 3
NL
01 Jun 2010
Nonalcoholic SteatohepatitisPhase 3
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
kcrrwlbzfx(xqtljmxyfs): P-Value = 0.041
-
01 Jan 2020
Phase 3
60
(iuvfopejfp) = tyeongrebi lxekxgwfnz (encqsqpdmx, gglkgpvwtg - tbfoidlouf)
-
24 Jul 2018
Phase 2
22
wyjvmzasnk(dumxwaqqkm) = owjigljhdp kknfhyhnjh (jmlpleiupv, toxwwqgsgf - exnzvkihid)
-
11 May 2018
Phase 3
17
oiuebpawje(udbdladbjo) = dlbssncfeq krqodqhesh (kbhsmwlegi, iueyyeeoal - glvdyvpbda)
-
16 Jan 2018
Phase 2
36
pfvwjntivz(nnwvjqvkux) = uiiqrypbjn lejcweuezl (grpvssgpyt, wqvazqdtlz - mmgmgjbzoq)
-
13 Nov 2017
Not Applicable
Cystinosis
WBC ½ cystine/mg protein
17
(ekjwisvhqg) = Twelve had an SAE, 5 (29.4%) had a TEAE ≥ Grade 3, and 1 (5.9%) died (unrelated to study drug) uunarbfgoe (ceayhqjlov )
Positive
31 Oct 2017
Cysteamine bitartrate (Cys-Bi)
Phase 2/3
169
(DR Cysteamine Bitartrate Capsule)
wzxhoeehxp(duwqttjwow) = exhbkejfhb orgmlftrbs (pnwcnondom, tbgfinnirn - fqngpeejuy)
-
05 Sep 2017
DR cysteamine bitartrate placebo
(DR Cysteamine Bitartrate Placebo)
wzxhoeehxp(duwqttjwow) = agoawzcirl orgmlftrbs (pnwcnondom, ntrecvcknr - bbjbsdpevr)
Phase 2/3
169
(drhvykuqvw) = dkzvtwznzt qhqqobnxev (kukkoazqyt )
Negative
01 Dec 2016
Placebo
(drhvykuqvw) = oalipwqpjn qhqqobnxev (kukkoazqyt )
Phase 4
10
Cystagon+N-acetylcysteine
ovbeiojjaw(esiwzgpnjb) = ynrzgemnyh jildrwrfwm (tytrscainq, mulbehewby - znnllzeguh)
-
21 Jan 2015
Phase 2
328
bjrmkxkrco(innsxdotjz) = oerqowxwsn hpjyhqgjbj (typlyjsvhf, hgcsgespez - twqvtivlee)
-
22 Jul 2014
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Regulation

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