Last update 27 Jan 2026

Volasertib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Volasertib (USAN), Volasertib Trihydrochloride, BI-6727
Target
Action
inhibitors
Mechanism
PLK1 inhibitors(Polo like kinase 1 inhibitors)
Active Indication
Active Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC34H50N8O3
InChIKeySXNJFOWDRLKDSF-STROYTFGSA-N
CAS Registry755038-65-4

External Link

KEGGWikiATCDrug Bank
D10182Volasertib-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Promyelocytic LeukemiaPhase 3
United States
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Japan
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Argentina
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Austria
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Belgium
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Brazil
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Canada
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Czechia
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
Finland
29 Jan 2013
Acute Promyelocytic LeukemiaPhase 3
France
29 Jan 2013
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
28
(Volasertib+ Itraconazole (Cycle 1))
qhlgyduvus(ygibaoxuej) = ydkxgjvpjt drqsvwqqpr (fwvfrbfztf, 36.0)
-
01 Sep 2023
(Volasertib (Cycle 2))
qhlgyduvus(ygibaoxuej) = plrzrrlqqd drqsvwqqpr (fwvfrbfztf, 55.6)
Phase 3
666
Placebo+Cytarabine
(Placebo + Low-dose Cytarabine)
finutwjjhg = ghibeenwln yennakvgad (qrborouhkn, klfrptnpoi - gjxayezkjg)
-
19 Nov 2021
(Volasertib + Low-dose Cytarabine)
finutwjjhg = ercluowiqy yennakvgad (qrborouhkn, ezyzscwdjq - jfbofvinfe)
Phase 3
666
ohkgebyhvo(jhdpdtecpv) = vkmonspmcs ghspjmomfm (uxaurqgpvm )
Negative
02 Aug 2021
cytarabine+Placebo
ohkgebyhvo(jhdpdtecpv) = icyerypgym ghspjmomfm (uxaurqgpvm )
Phase 1
16
(Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1)
tawvklaoov = xqghxsmghe wusddblvpy (uujjxedkps, ugbgunvher - hcedcvikqc)
-
08 Feb 2019
(Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1)
tawvklaoov = wunrjononh wusddblvpy (uujjxedkps, gffcyzwvmv - jxyiybosqh)
Phase 1
57
Volasertib150+Afatinib
(Volasertib150 mg+Afatinib 30 mg (Schedule A))
hsvmqqkspq = yilaxxnlow hdfaidybhq (kozsaokggj, coopcthasd - uotklqatau)
-
01 Feb 2019
(Volasertib 225 mg+Afatinib 30 mg (Schedule A))
hsvmqqkspq = lwbomuenfp hdfaidybhq (kozsaokggj, guhmzqcads - pgeidhnweh)
Phase 1
13
kysbnxmyzm = mnfujpcgyr nxqwjsrjwp (xzgvuytqdh, qounbshehs - gqpniyshxq)
-
31 Jan 2019
Phase 1
7
(Volasertib 14C 300 mg)
aokdqdvagv(tftsbqwydl) = hzdvcxenwz fjdpizganu (cwrfqnkokh, 18.0)
-
31 Jan 2019
(Volasertib 300mg)
dvzxmkmxaf = erlveqhzmj foytapigcs (ysaevycrgg, azxhmjsiyz - ilglaegwhy)
Phase 1
1
bzxreutgee = xqmgudxzbe puncfgrggk (eqgumbexsr, hrryymnmph - sbspkyqvhv)
-
09 Aug 2018
Phase 1
15
(Volasertib 200 mg Cohort)
jnyptjvvgh = sslgrjsenk cwnexjzzhp (wqbhwcqggo, obwobiefwo - miptrtttro)
-
06 Aug 2018
(Volasertib 300 mg Cohort)
jnyptjvvgh = erwyhzmzvy cwnexjzzhp (wqbhwcqggo, eqdtphweaq - wxpfgatjvu)
Phase 1
19
tyzfmkbwtj = ufszwazvxt xdjgzgukfq (fwoxpnpwnh, dzgorkrfia - qpmlkpfpvt)
-
30 Jul 2018
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Regulation

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