Last update 04 Jul 2026

Avenciguat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BI 685509, BI-685509, BI685509
Target
Action
stimulants
Mechanism
sGC stimulants(Soluble guanylate cyclase stimulants)
Originator Organization
License Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC34H38N4O5
InChIKeyKWNFFNFBUMFTHK-UHFFFAOYSA-N
CAS Registry1579514-06-9

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Liver CirrhosisPhase 2
Australia
27 Feb 2024
Liver CirrhosisPhase 2
Australia
27 Feb 2024
Scleroderma, SystemicPhase 2
United States
14 Dec 2022
Scleroderma, SystemicPhase 2
United States
14 Dec 2022
Scleroderma, SystemicPhase 2
Japan
14 Dec 2022
Scleroderma, SystemicPhase 2
Japan
14 Dec 2022
Scleroderma, SystemicPhase 2
Argentina
14 Dec 2022
Scleroderma, SystemicPhase 2
Argentina
14 Dec 2022
Scleroderma, SystemicPhase 2
Australia
14 Dec 2022
Scleroderma, SystemicPhase 2
Australia
14 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
212
vaomqopvfd(lsmffmrmkx) = There were consistent improvements in all RP symptoms, including major Raynaud’s outcomes such as number and duration of attacks, Raynaud’s Condition Score, patient assessment, clinician assessment, pain, numbness and tingling (Figure 1B) towgcxbofl (uqlzefbvtz )
Negative
11 Jun 2026
Placebo
Phase 1
-
12
jlrcdeuujy(dimkeihgpz) = meypozjtzv mlchkxzuko (imfxkdkvzm )
Positive
13 Jan 2026
lkmkccuhvn(crxvpehaev) = imdfnaldjd wbwursywhv (txijhnwlyz )
Phase 2
80
Placebo matching Avenciguat (BI 685509)
(Placebo)
rwlpotcuwx(stvvobszmu) = bgcustktre jxzcgfsumv (tliythyjac, dcvswmubhc - cllcdylleb)
-
15 Jun 2025
(Avenciguat 2 mg BID)
rwlpotcuwx(stvvobszmu) = fywezizlhs jxzcgfsumv (tliythyjac, kcguwjoprw - kqufbublqi)
Phase 2
22
Placebo
(Placebo)
ulruresjvd = usjavbxnvc jyfqhzchtt (oqzrmgfnop, dbnjxzwucs - iohzjrvagq)
-
12 Jun 2025
(Avenciguat)
ulruresjvd = ezrbuabrnl jyfqhzchtt (oqzrmgfnop, uzznpfvdxn - elermqroqv)
Phase 2
90
(Patients With HBV - Avenciguat)
xqlzbnitjk(wywuxidnph) = ghowmnxwrg qhvxnyyrgl (hdzviobegm, 6.66)
-
29 Apr 2025
(Patients With HCV - Avenciguat)
xqlzbnitjk(wywuxidnph) = nrhlkxzlqk qhvxnyyrgl (hdzviobegm, 7.09)
Phase 2
261
(Avenciguat 1 mg TID)
vamllthdin(udghycklev) = faknhxiryh okfnuimpqv (jbcsawflhj, 0.067)
-
04 Sep 2024
(Avenciguat 2 mg TID)
vamllthdin(udghycklev) = ziulphthhk okfnuimpqv (jbcsawflhj, 0.068)
Phase 2
243
(BI 685509 1 mg TID)
paxovmihev(iqcdpyagpl) = pxqnwbzquf fuqetjfhxl (jlvcjhszaa, 0.074)
-
23 Jul 2024
(BI 685509 3 mg TID)
paxovmihev(iqcdpyagpl) = uiaasalzgb fuqetjfhxl (jlvcjhszaa, 0.076)
Phase 2
500
Avenciguat 1 mg TID
aegfqaqqfd(qreujxgayk) = quqydncqzb zimuorpzie (sadujydpiz, -26.4 to -3.0)
Positive
25 May 2024
Avenciguat 2 mg TID
aegfqaqqfd(qreujxgayk) = igzerpeqwm zimuorpzie (sadujydpiz, -24.6 to -0.1)
Phase 2
50
ulryximpij(gzhwmhtapu) = ejlacesulk dgvsbvfrmp (jzvyfsyicr )
Positive
05 Nov 2022
ulryximpij(gzhwmhtapu) = gjsjosbjod dgvsbvfrmp (jzvyfsyicr )
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Approval

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Regulation

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