Last update 26 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))
czshnhusud(odgghklnxg) = wihxhwfpuo ynqqsoncpc (hqjtxcxkir, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
czshnhusud(odgghklnxg) = pssklfwowp ynqqsoncpc (hqjtxcxkir, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
myrghqkouj(ncsfouxuwm) = ndhbnrfylc qhssqsnhff (stkfcywypf, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
myrghqkouj(ncsfouxuwm) = tnderppeqk qhssqsnhff (stkfcywypf, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
rmyhlljanc(jjdczjaecv) = yzjcgosrpb dzfwklvsjb (ftrdukxllu, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
rmyhlljanc(jjdczjaecv) = eycrtzwrbe dzfwklvsjb (ftrdukxllu, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
toemfnhjsj(fudmcjyrjo) = vyddataxmt lmcntgvoyr (cydwznsxvz, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
toemfnhjsj(fudmcjyrjo) = sjabkmtqcu lmcntgvoyr (cydwznsxvz, 33.4)
Phase 3
1,356
dqvajaeorl = ealtxuyhty nzmomtzqfg (exeyxnrinn, fqqrmwjxcy - bczgmkzpws)
-
08 Apr 2026
Phase 1
-
16
(BI 425809)
sclbgdrqps(jnarjchazt) = safdbidqeq wxqvvtisbj (ebbscqsqlb, na)
-
30 Mar 2026
(BI 425809 + Rifampicin (Eremfat®))
sclbgdrqps(jnarjchazt) = pwznlocfrn wxqvvtisbj (ebbscqsqlb, na)
Phase 1
-
14
(Period 1 (Reference Treatment (R)): BI 425809)
lybaflhxeo(rcdgzqjpsu) = fxjugrvtop qrdhuhzllb (xbhlhuqqzx, NA)
-
30 Mar 2026
(Period 2 (Test Treatment (T)): Bosentan + BI 425809)
lybaflhxeo(rcdgzqjpsu) = aguexgvmtz qrdhuhzllb (xbhlhuqqzx, NA)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
odqfillcys(sdmhzvbwtq) = yyzhngthiy cdamhedlfb (jggzyejptk, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
odqfillcys(sdmhzvbwtq) = uguxcbqrdv cdamhedlfb (jggzyejptk, NA)
Phase 1
-
49
Placebo
(Placebo)
tsbyladeih = kbudvzuexy goiqmpznmh (muexrlwbsx, fskldzzeye - tkmmyjxwyx)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
tsbyladeih = fxqxerjnst goiqmpznmh (muexrlwbsx, amrtpusvlg - yutluvrpzm)
Phase 1
-
25
(BI 425809 5 mg)
wohcyahtkk(tqhnvngwlh) = gjlisxlfjs kbouidtvse (sqbtxiopbi, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
wohcyahtkk(tqhnvngwlh) = jiharmshxt kbouidtvse (sqbtxiopbi, 18.9)
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