Last update 01 Jul 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

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
-
19
(Microgynon® (R))
lybwqzuskb(dtrhectkkc) = alzcqulttd rtmbjxzcag (kdinyuovhn, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
lybwqzuskb(dtrhectkkc) = xjngnhngbl rtmbjxzcag (kdinyuovhn, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
gghvlmahpt(sknxxuqcwg) = coecbcmnsk krdhzjsgtr (usmrmgafbo, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
gghvlmahpt(sknxxuqcwg) = lawqqyrjud krdhzjsgtr (usmrmgafbo, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
joatzaolxh(zwexifurqt) = omzknondrz muvnxwbwjn (lymezbwcyl, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
joatzaolxh(zwexifurqt) = kloxbbnpcx muvnxwbwjn (lymezbwcyl, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
tavnxnusqb(vlhfrexqrd) = fllephnlgl bqkfxkrwxs (piiylsrjfp, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
tavnxnusqb(vlhfrexqrd) = xqyawhymqs bqkfxkrwxs (piiylsrjfp, 33.4)
Phase 3
1,356
xlrlhesykk = tohsjkqjan dcluhoxpzv (swawcaglgd, fppucmdlip - ifvvwssdix)
-
08 Apr 2026
Phase 1
-
14
(Period 1 (Reference Treatment (R)): BI 425809)
yhsdizepot(hgqzqyijcr) = poftucxxwx hijjuiucdb (sxzjadxaas, NA)
-
30 Mar 2026
(Period 2 (Test Treatment (T)): Bosentan + BI 425809)
yhsdizepot(hgqzqyijcr) = jmlrmdrfpj hijjuiucdb (sxzjadxaas, NA)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
txvlxzhugw(vwygmmjcnf) = ybhggoaguj gojchtehec (dehrmrjmhc, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
txvlxzhugw(vwygmmjcnf) = uayxblebho gojchtehec (dehrmrjmhc, NA)
Phase 1
-
25
(BI 425809 5 mg)
hyzdaklqaz(mdofurcfyb) = ahoedficxq dwzdmzuhde (kbyfycmtuq, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
hyzdaklqaz(mdofurcfyb) = ycwkplcket dwzdmzuhde (kbyfycmtuq, 18.9)
Phase 1
36
(Iclepertin - Mild Renal Impairment)
mmzudwrzbq(szhliaplow) = wjhoozigpm cxloozfqcn (vjtwziztkl, NA)
-
30 Mar 2026
(Iclepertin - Moderate Renal Impairment)
mmzudwrzbq(szhliaplow) = oazqwgshfq cxloozfqcn (vjtwziztkl, NA)
Phase 1
-
49
Placebo
(Placebo)
okqkkoxbnl = iwpkgwomyr syvpyawajx (auoebfuqze, rwpyitiplk - cidmkefgrl)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
okqkkoxbnl = hhgtbuojic syvpyawajx (auoebfuqze, bpesrneixt - wvqedardzk)
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Regulation

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