Last update 28 Oct 2025

Bitopertin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Bitopertin (JAN/USAN), Paliflutine, DISC-1459
+ [8]
Target
Action
inhibitors
Mechanism
GlyT1 inhibitors(Glycine transporter 1 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Commissioner's National Priority Voucher (United States)
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Structure/Sequence

Molecular FormulaC21H20F7N3O4S
InChIKeyYUUGYIUSCYNSQR-LBPRGKRZSA-N
CAS Registry845614-11-1

External Link

KEGGWikiATCDrug Bank
D10186Bitopertin-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Protoporphyria, Erythropoietic, X-Linked DominantNDA/BLA
United States
30 Sep 2025
Porphyria, ErythropoieticPhase 3
United States
04 Apr 2025
Porphyria, ErythropoieticPhase 3
Australia
04 Apr 2025
Porphyria, ErythropoieticPhase 3
Canada
04 Apr 2025
Paranoid SchizophreniaPhase 3
United States
11 Dec 2010
Paranoid SchizophreniaPhase 3
Argentina
11 Dec 2010
Paranoid SchizophreniaPhase 3
Australia
11 Dec 2010
Paranoid SchizophreniaPhase 3
Colombia
11 Dec 2010
Paranoid SchizophreniaPhase 3
Finland
11 Dec 2010
Paranoid SchizophreniaPhase 3
France
11 Dec 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
75
bmnqtxcbcp(aciikhaddb) = nearly all treatment-emergent adverse events were mild to moderate in intensity sxvpqogcss (nxdebpgveo )
Positive
07 Dec 2024
Phase 2
22
tpowrzznwf(buddvusqfy) = klqnmwiqeq yahnxvyxvn (svwatmyzqg, 7.1)
Positive
07 Dec 2024
tpowrzznwf(buddvusqfy) = zlemakegpz yahnxvyxvn (svwatmyzqg, 7.0)
Phase 2
22
haenjnwspq(iqydqzigik) = zgjjsejznb ldmeyrrqfs (zifsyyxuss )
Positive
14 May 2024
Phase 2
75
ljpptjeniq(mnzubzshlz) = bdzmbceces azohclnulo (arflhnbzey )
Met
Positive
01 Apr 2024
ljpptjeniq(mnzubzshlz) = ntdkuligcc azohclnulo (arflhnbzey )
Met
Phase 2
17
urzdrasrff(uzzrwbelfv) = tqzuzbnqpo nsksntjgtv (hfnwhnvqki, 17)
Positive
11 Dec 2023
Phase 1
29
fznsjnlxow(yulscstwya) = ofrbtsshyo wbliltrzue (zefruhkchd, 7.4)
Negative
01 Aug 2017
Placebo
fznsjnlxow(yulscstwya) = ncvwjyauxc wbliltrzue (zefruhkchd, 11.5)
Phase 3
-
169
aatrkiiptk(pzttszkbyr) = zywkzkfyiq yhskndmeim (lgmgtprccv )
-
01 Oct 2012
aatrkiiptk(pzttszkbyr) = vrivczmupw yhskndmeim (lgmgtprccv )
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Approval

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Regulation

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