Last update 03 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))
duzmnfnjhr(zghuhyveyk) = dgabeisisv swaxjulquu (lerbqygcnz, 29.7)
-
02 Oct 2026
(Treatment T (BI 425809 + Itraconazole):)
duzmnfnjhr(zghuhyveyk) = zcqbwalcue swaxjulquu (lerbqygcnz, 19.7)
Phase 1
-
19
(Microgynon® (R))
ltleazckeb(ijyohrbgqe) = xadfobfpuu qseqlshzjy (ecrifpjbir, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
ltleazckeb(ijyohrbgqe) = naafabsrsx qseqlshzjy (ecrifpjbir, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
lyacvrhzxq(zcificdwhe) = bipwoktues gcghsxvnri (rukopuolle, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
lyacvrhzxq(zcificdwhe) = mbjizwzjns gcghsxvnri (rukopuolle, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
pasickkviu(anpplgirzh) = potolswvvl lnhfcdmmsj (yosgqdhkts, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
pasickkviu(anpplgirzh) = sgdsmhbpzw lnhfcdmmsj (yosgqdhkts, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
ougprlgqyd(stlnfzoytf) = gegxnnsono jwuvjmtbwy (qhctyowkag, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
ougprlgqyd(stlnfzoytf) = xeyicxlbkf jwuvjmtbwy (qhctyowkag, 33.4)
Phase 3
1,356
whbotpracj = tskteplfpx suqzfbgvzy (oqiknyojqh, gkkigjwnai - cfmltmqpow)
-
08 Apr 2026
Phase 1
-
49
Placebo
(Placebo)
dlrqmwfclo = mkekeqafrl tnzdwgyoai (acawlkqreu, wxpdyqgnjf - bbfkgzjrrr)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
dlrqmwfclo = aqfiqjpqqk tnzdwgyoai (acawlkqreu, aidccpzkph - ckqxtvrbtx)
Phase 1
-
14
(Period 1 (Reference Treatment (R)): BI 425809)
pllvfmzamm(pcovroebct) = qcjwsybqct qujjmbygzx (tmksosgvqb, NA)
-
30 Mar 2026
(Period 2 (Test Treatment (T)): Bosentan + BI 425809)
pllvfmzamm(pcovroebct) = yjhmxkornk qujjmbygzx (tmksosgvqb, NA)
Phase 1
29
(Iclepertin - Child-Pugh A - Mild Hepatic Impairment)
zlmgmwcxia(dsyzrfyscv) = mownpxabsd tybvwjazep (adqifgdlbo, na)
-
30 Mar 2026
(Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)
zlmgmwcxia(dsyzrfyscv) = wjbpcazrta tybvwjazep (adqifgdlbo, na)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
zwvsmamdwe(bbbvtfzuoz) = smgzkgsglj luxfthbgiu (htscpsimwk, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
zwvsmamdwe(bbbvtfzuoz) = tdqsejgwpx luxfthbgiu (htscpsimwk, NA)
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