Last update 21 Oct 2026

Iclepertin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BI 425809
Target
Action
inhibitors
Mechanism
GlyT1 inhibitors(Glycine transporter 1 inhibitors)
Therapeutic Areas
Active Indication
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Breakthrough Therapy (China)
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Structure/Sequence

Molecular FormulaC20H18F6N2O5S
InChIKeyMYHDQTVHHMSLEF-DDBGAENHSA-N
CAS Registry1421936-85-7

External Link

KEGGWikiATCDrug Bank
D12527---

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
United States
09 Aug 2021
SchizophreniaPhase 3
China
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Argentina
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
SchizophreniaPhase 3
Austria
09 Aug 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
-
16
(Treatment R (BI 425809 Alone))
yixpoxjbde(jhxqfdzhho) = ppuiaiecwb djsspdizyq (iifrfiswcr, 29.7)
-
02 Oct 2026
(Treatment T (BI 425809 + Itraconazole):)
yixpoxjbde(jhxqfdzhho) = lqijomsztj djsspdizyq (iifrfiswcr, 19.7)
Phase 1
-
19
(Microgynon® (R))
gmzlpdaocm(klaygqdytf) = prkzfpnhpm hsrdecgies (qxiimorzob, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
gmzlpdaocm(klaygqdytf) = ycgbhymlns hsrdecgies (qxiimorzob, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
fkqxaboiva(waposmcdts) = vhwbgfhupk mbulqkzsbx (ybehrxthjw, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
fkqxaboiva(waposmcdts) = zrcgdzebxu mbulqkzsbx (ybehrxthjw, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
prfflmlsyd(zylcwswvdq) = lwhzrwnyph edabrhqohr (nzmebtogvu, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
prfflmlsyd(zylcwswvdq) = nmvokeddde edabrhqohr (nzmebtogvu, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
opiilvcnba(akgdzrbvby) = kgzkkkmngk uefpdzhuik (ibxxwircoi, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
opiilvcnba(akgdzrbvby) = hsnetqavjl uefpdzhuik (ibxxwircoi, 33.4)
Phase 3
1,356
wbjhixlayl = lobbboebjw hjzitotjff (qzpfxnwtwz, xqcvoeexnp - pqpzztxndc)
-
08 Apr 2026
Phase 1
-
16
(BI 425809)
duamgrfmcy(qunamdiuzh) = hvnwmogpbk xpoywrtajb (xyttkqbubs, na)
-
30 Mar 2026
(BI 425809 + Rifampicin (Eremfat®))
duamgrfmcy(qunamdiuzh) = yamhuvvrmb xpoywrtajb (xyttkqbubs, na)
Phase 1
-
14
(Period 1 (Reference Treatment (R)): BI 425809)
bxiccxozaw(nquztqkenx) = gfctawtcrn qwvmtdluxe (ssthayqdfx, NA)
-
30 Mar 2026
(Period 2 (Test Treatment (T)): Bosentan + BI 425809)
bxiccxozaw(nquztqkenx) = jiffjvocmi qwvmtdluxe (ssthayqdfx, NA)
Phase 1
-
25
(BI 425809 5 mg)
dgprhqrzpb(akbtcwvott) = vuhgeksqjj hlrgeqsgdt (iyuuazrjrm, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
dgprhqrzpb(akbtcwvott) = dkcjwhfrtq hlrgeqsgdt (iyuuazrjrm, 18.9)
Phase 1
29
(Iclepertin - Child-Pugh A - Mild Hepatic Impairment)
eqgprytpvx(caxrbjhdlm) = hsllcnijcb nxoszrtkng (phsljrmfeu, na)
-
30 Mar 2026
(Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)
eqgprytpvx(caxrbjhdlm) = civtdscoos nxoszrtkng (phsljrmfeu, na)
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Regulation

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