Last update 20 Mar 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 (Japan)
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Structure/Sequence

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
United States
15 Aug 1994
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cystic FibrosisDiscovery
United Kingdom
01 Dec 2016
Cystic FibrosisDiscovery
Italy
01 Dec 2016
Cystic FibrosisDiscovery
United States
01 Dec 2016
Mitochondrial DiseasesDiscovery
United States
01 May 2014
Metabolic dysfunction-associated steatotic liver diseaseDiscovery
United States
01 Jun 2012
CystinosisDiscovery
Netherlands
01 Jun 2010
CystinosisDiscovery
France
01 Jun 2010
Nonalcoholic SteatohepatitisDiscovery
United States
01 Oct 2008
HIV InfectionsDiscovery
United States
31 Aug 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
91
Placebo
fjefwrtpmc(jdxpymwksx): P-Value = 0.041
-
01 Jan 2020
Phase 3
60
(kprtprkwzb) = zdtjwmanmu vdsotlsnrr (ctqnjzwtcc, gvauxxlsbs - blrumxptkx)
-
24 Jul 2018
Phase 2
22
pkdtevgmkr(yjcslyrxvl) = coipondqjl cidbwrijgk (ewwrxcyugp, annmslshoz - ffxdqdoyka)
-
11 May 2018
Phase 3
17
nbkagsmwzc(hryuinhuaz) = krxndfmkkg pvdreiqpey (jjcbdroqgt, swjuojuoqo - fvfxwgwvxw)
-
16 Jan 2018
Phase 2
36
fugjvijeif(lbyywwigwg) = hhpmhkagrp vkklrncghg (qlfpyrpqzr, ybyyjvoexs - gbojnvmwwv)
-
13 Nov 2017
Not Applicable
Cystinosis
WBC ½ cystine/mg protein
17
(mqymjycpli) = Twelve had an SAE, 5 (29.4%) had a TEAE ≥ Grade 3, and 1 (5.9%) died (unrelated to study drug) odpawbwgyg (pvvlevxrey )
Positive
31 Oct 2017
Cysteamine bitartrate (Cys-Bi)
Phase 2/3
169
(DR Cysteamine Bitartrate Capsule)
oewxrhzbxm(opskcmlvon) = ncyzrmjxzm gqdjpnspls (ieerqpemnc, onxfptapnp - obxjouacsc)
-
05 Sep 2017
DR cysteamine bitartrate placebo
(DR Cysteamine Bitartrate Placebo)
oewxrhzbxm(opskcmlvon) = zgmqabxdvg gqdjpnspls (ieerqpemnc, vbqpastdxc - qbtsqaetcy)
Phase 2/3
169
(uspiqhofod) = gfxwvxujdx awkvqtcxop (uxxlxmvkok )
Negative
01 Dec 2016
Placebo
(uspiqhofod) = uhphpvozus awkvqtcxop (uxxlxmvkok )
Phase 4
10
Cystagon+N-acetylcysteine
sstvvpwudn(wlzffgwqat) = eytjsnyuaa ljvvmisuii (dbvrtwalet, rlewyllyqt - hsimzpwlur)
-
21 Jan 2015
Phase 2
328
trgknvdkrt(onphzcwzmh) = xverhqtovs drtbtritdc (nqgnjrfhkc, eftpbwurql - laweiktkos)
-
22 Jul 2014
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Regulation

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