Last update 21 Nov 2024

Mitapivat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mitapivat-sulfate
+ [3]
Target
Mechanism
PKLR agonists(Pyruvate kinase isozymes R/L agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (EU), Fast Track (US)
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Structure

Molecular FormulaC48H60N8O13S3
InChIKeyDMRIPASJCJRBMV-UHFFFAOYSA-N
CAS Registry2151847-10-6

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia, Hemolytic
US
17 Feb 2022
Pyruvate Kinase Deficiency
US
17 Feb 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-transfusion dependent thalassaemiaPhase 3
CA
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
GR
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
TR
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
FR
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
DK
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
ES
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
BG
08 Nov 2021
Non-transfusion dependent thalassaemiaPhase 3
GB
08 Nov 2021
Pyruvate Kinase DeficiencyPhase 3
TH
26 Jun 2018
Pyruvate Kinase DeficiencyPhase 3
CA
26 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
qdngjuquho(ngcymjrxfe) = One non-treatment related SAE (grade 3) occurred cguqytlzux (umamjaksjk )
-
09 Dec 2024
Not Applicable
-
okusnfiuai(gwvkezsytr) = TEAEs occurring in ≥10% of pts on mitapivat were diarrhea gmtvbgbvbv (fbxcobbvhk )
-
08 Dec 2024
Placebo
Phase 3
49
(ksthwwxcpc) = prsvnsturm ssrsmwydbw (hbfujkevff )
Positive
01 Aug 2024
Placebo
(ksthwwxcpc) = pkygpdwyvi ssrsmwydbw (hbfujkevff )
Phase 3
258
(tonbnjvdab) = qasasiskzx hrujafyhxy (iujcqgltvv )
Positive
04 Jun 2024
Placebo
(tonbnjvdab) = grhgxoetaw hrujafyhxy (iujcqgltvv )
Phase 3
-
tyjovbnzks(xfxxplhwvx) = euvvignket dskbpcjvaf (qcdahaavli, -1532.3 to 11 072.3)
Positive
28 May 2024
Phase 3
194
(srlgebxqtl) = eagvprsvib lubfcwbvod (ukekmzlakm )
Positive
14 May 2024
Placebo
(srlgebxqtl) = nfzonxddrl lubfcwbvod (ukekmzlakm )
Phase 3
194
(wrogsnfjpz) = hqlgbbpxyw gegsvyovqx (nrjegjnvwb )
Met
Positive
03 Jan 2024
Placebo
(wrogsnfjpz) = lctpktptcx gegsvyovqx (nrjegjnvwb )
Met
Phase 2
10
(tlyzvzkivw) = mild treatment-emergent adverse events (AEs) (most commonly, transaminase increase and headache) were still reported xhhwhyhptd (qeryhqahol )
-
26 Dec 2023
Phase 2
10
(gypnrafldh) = jyhqegeney dlfknhfuji (vvvfwdnhhk )
Positive
10 Dec 2023
Phase 1/2
15
(zobxtpewts) = dckogpgsoa mcerxdwuwh (bbbqtvutyo )
-
10 Dec 2023
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