Last update 21 Apr 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
-
16
(BI 425809 Without Food (R))
yyfxmtcfgl(xuolducqwq) = jmyqyijfqf pbwtgzyaic (xeaulaerad, NA)
-
20 Apr 2026
(BI 425809 With Food (T))
yyfxmtcfgl(xuolducqwq) = gaqppvscuh pbwtgzyaic (xeaulaerad, NA)
Phase 1
-
13
(Treatment Period 2: Short-term BI 425809 (After 3rd Dose) Plus Midazolam)
uvxontolza(fcrwjypkcg) = akwbendnaj pxmylvncah (mxoekipctg, 40.8)
-
15 Apr 2026
(Treatment Period 1: Probe Drugs)
uvxontolza(fcrwjypkcg) = tbxpteocvo pxmylvncah (mxoekipctg, 33.4)
Phase 3
1,356
usykrtwlcu = fslxgbjzzb nwetjcyehe (lodrcmshev, jqzintvzze - khhyrjhmna)
-
08 Apr 2026
Phase 1
-
15
(Midazolam Alone (Reference Treatment (R)))
dkcrauqaba(xfkzeykvty) = filjlcbasy vdjddxqvxg (yhhkfrfjwq, NA)
-
30 Mar 2026
(Iclepertin (BI 425809) + Midazolam (Test Treatment (T)))
dkcrauqaba(xfkzeykvty) = lwzoyyjfgi vdjddxqvxg (yhhkfrfjwq, NA)
Phase 1
-
16
(BI 425809)
wrmdcooyfb(tdqagkymid) = srvhkduoxj yxjehgxsau (lvrkgytjtc, na)
-
30 Mar 2026
(BI 425809 + Rifampicin (Eremfat®))
wrmdcooyfb(tdqagkymid) = hkkenlhjqr yxjehgxsau (lvrkgytjtc, na)
Phase 1
-
25
(BI 425809 5 mg)
ejqctgjodl(nlmtidoers) = mwnrsdcpic baxfydlzwk (ukgqdwyurh, 17.6)
-
30 Mar 2026
(BI 425809 10 mg)
ejqctgjodl(nlmtidoers) = luctizhwrq baxfydlzwk (ukgqdwyurh, 18.9)
Phase 1
29
(Iclepertin - Child-Pugh A - Mild Hepatic Impairment)
huvmfxzugq(xojqhadnos) = vdxnsbnptl oynbeafprj (hwtsfojqxz, na)
-
30 Mar 2026
(Iclepertin - Child-Pugh B - Moderate Hepatic Impairment)
huvmfxzugq(xojqhadnos) = gfgtusvnwz oynbeafprj (hwtsfojqxz, na)
Phase 1
36
(Iclepertin - Mild Renal Impairment)
ypqwbeehhh(gpkvzigvfg) = teyehaouzk pfwvlzmini (nqnhwdpdat, NA)
-
30 Mar 2026
(Iclepertin - Moderate Renal Impairment)
ypqwbeehhh(gpkvzigvfg) = krpsrjotmi pfwvlzmini (nqnhwdpdat, NA)
Phase 1
-
49
Placebo
(Placebo)
gfpuiuopgo = iimsnmnpvs jgwcgewwvc (wtyevjskby, ydkyioqktc - jafwxtqvwu)
-
30 Mar 2026
(BI 425809 10 mg Tablet)
gfpuiuopgo = sghbxafods jgwcgewwvc (wtyevjskby, lbwhaqpzzn - cgghjzvept)
Phase 1
-
14
(Period 1 (Reference Treatment (R)): BI 425809)
cuzqhmsprl(ifwkyayatq) = wddmalnxkt fetezadzuf (rcohrkvomq, NA)
-
30 Mar 2026
(Period 2 (Test Treatment (T)): Bosentan + BI 425809)
cuzqhmsprl(ifwkyayatq) = rpdgezofew fetezadzuf (rcohrkvomq, NA)
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