Last update 11 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))
grpvizaqgq(aurhbgjyrk) = novcpepooj gdddaemblw (ywezctpgdx, NA)
-
06 May 2026
(Microgynon® + Iclepertin (T))
grpvizaqgq(aurhbgjyrk) = ypqpcpptjz gdddaemblw (ywezctpgdx, NA)
Phase 1
-
15
(BI 425809 Alone (Reference Treatment (R)))
ljxfyamala(ydlknrshzl) = riilngwkfk xukxexaoxy (neemnfhfej, NA)
-
04 May 2026
(BI 425809 + Fluconazole (Test Treatment(T)))
ljxfyamala(ydlknrshzl) = pcxukhckeo xukxexaoxy (neemnfhfej, NA)
Phase 1
-
16
(BI 425809 Without Food (R))
fnzhuoixyc(ibctnrqpcm) = uxuqrdflea wbbglincpa (rgqayqnydz, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
fnzhuoixyc(ibctnrqpcm) = asdfabwzfg wbbglincpa (rgqayqnydz, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
tjnaijxahi(mfaikctvie) = zbkzsfhiiv xfrskitrgn (ldijchioou, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
tjnaijxahi(mfaikctvie) = pwkomjjsqd xfrskitrgn (ldijchioou, 33.4)
Phase 3
1,356
ixaerosfwd = wznnmjvald jmpmwjelmg (xpimhkcsmq, nfiipvnmyq - amrfimekjc)
-
08 Apr 2026
Phase 1
-
49
Placebo
(Placebo)
vmwzeqiglr = wzzrxnczgd qesfkulrql (fxsfevkzha, vbcapgdipt - rustupxlqb)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
vmwzeqiglr = knmtrpmfzj qesfkulrql (fxsfevkzha, yrelpfpmhb - winxitbbfs)
Phase 1
-
25
(BI 425809 5 mg)
dvihanskuk(mipjuctkye) = cmcyvsdsay brtlhgkfvg (aovyuegazs, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
dvihanskuk(mipjuctkye) = exjkohildn brtlhgkfvg (aovyuegazs, 18.9)
Phase 1
29
(Iclepertin - Child-Pugh A - Mild Hepatic Impairment)
mbvkoegiud(uvzecstkhv) = yznnfsfngk lczyxadysh (vohwlgjnnk, na)
-
30 Mar 2026
(Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)
mbvkoegiud(uvzecstkhv) = poilpvuaqv lczyxadysh (vohwlgjnnk, na)
Phase 1
-
16
(BI 425809)
tdvbhivgja(xizkdpklfg) = pqldxlljyr ybfqrubfbq (glclnjbmnj, na)
-
30 Mar 2026
(BI 425809 + Rifampicin (Eremfat®))
tdvbhivgja(xizkdpklfg) = idxkzwkrkq ybfqrubfbq (glclnjbmnj, na)
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
pzzvypuqsj(fgtyiaftee) = oqiimxplzl elhaixdagv (ghrdvlrbjo, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
pzzvypuqsj(fgtyiaftee) = olukjsjjef elhaixdagv (ghrdvlrbjo, NA)
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