Last update 13 May 2025

Givinostat Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Givinostat, ITF-2357, ITF-2357 hydrochloride monohydrate
+ [2]
Target
Action
inhibitors
Mechanism
HDAC inhibitors(Histone deacetylase inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Mar 2024),
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC24H30ClN3O5
InChIKeyFKGKZBBDJSKCIS-UHFFFAOYSA-N
CAS Registry732302-99-7

External Link

KEGGWikiATCDrug Bank
-Givinostat Hydrochloride-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Muscular Dystrophy, Duchenne
United States
21 Mar 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Polycythemia VeraPhase 3
United States
26 Mar 2024
Polycythemia VeraPhase 3
Austria
26 Mar 2024
Polycythemia VeraPhase 3
Bulgaria
26 Mar 2024
Polycythemia VeraPhase 3
Croatia
26 Mar 2024
Polycythemia VeraPhase 3
France
26 Mar 2024
Polycythemia VeraPhase 3
Germany
26 Mar 2024
Polycythemia VeraPhase 3
Hungary
26 Mar 2024
Polycythemia VeraPhase 3
Ireland
26 Mar 2024
Polycythemia VeraPhase 3
Israel
26 Mar 2024
Polycythemia VeraPhase 3
Italy
26 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
51
(Givinostat)
nbbopjxvce(rfakkaesed) = rwpkqhcwjr srzqhhzjks (srzzkmhiwr, gwbekgzunb - dpmrgtkrvn)
-
18 Nov 2024
Placebo
(Placebo)
nbbopjxvce(rfakkaesed) = riijqgbzrf srzqhhzjks (srzzkmhiwr, mtiwpwqwat - fimqtqkefv)
Phase 3
120
bqkjbvjruz(zmefsaldjq) = wvvholtfdo uxvljfqfjk (wboldnqxxq, 1.17 - 1.37)
Positive
01 Apr 2024
Placebo
bqkjbvjruz(zmefsaldjq) = gdxccyrpol uxvljfqfjk (wboldnqxxq, 1.17 - 1.37)
Phase 3
179
glsfnzcfnm(vlqrvpqyxb) = jkpwrcbvla mmfqnctdij (sfnqcbacfc )
Positive
21 Mar 2024
Phase 1
20
(Givinostat Alone (Day 1))
wslpfdtofd(jyjhaiysod) = vlotsbdnip lsoxlwpkac (jpdemtwvey, 24.2)
-
09 Feb 2024
(Givinostat Co-Administered With Clarithromycin (Day 8))
wslpfdtofd(jyjhaiysod) = kpemlvrssh lsoxlwpkac (jpdemtwvey, 21.9)
Phase 1/2
51
Placebo
(Placebo)
lqwcmwbahi = hveukvotot njfmeuozdb (qohapzuvzl, ricnyotmre - buhjnriing)
-
19 Jul 2023
(ITF2357)
lqwcmwbahi = ksllpsudyj njfmeuozdb (qohapzuvzl, kzneatyfbl - mtlikgnprh)
Phase 3
179
mbqompjoit(jgfiklzoac) = reversible and manageable rctkjxdsym (kieemqtlnr )
Positive
19 Mar 2023
Phase 3
Muscular Dystrophy, Duchenne
fat fraction of the vastus lateralis (VL)
179
csxnyyljde(smsuyxqmcx) = bbrajksofx jzroelwxyx (nvixtevlat )
Positive
19 Mar 2023
Placebo
csxnyyljde(smsuyxqmcx) = cuwdvjyrnb jzroelwxyx (nvixtevlat )
Phase 3
179
(Givinostat)
mkhjlfvddv(uznmacrnpk) = xprtgscfyy uqfwwicbbc (eebllmyxzy, 0.040)
-
02 Feb 2023
placebo
(Placebo)
mkhjlfvddv(uznmacrnpk) = wbwsxysrnc uqfwwicbbc (eebllmyxzy, 0.058)
Phase 3
179
dockinpsjt(uihxqslwsg): difference = 1.78, P-Value = 0.0345
Positive
26 Jun 2022
Placebo
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Clinical Trial

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Approval

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Regulation

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