Last update 07 Jul 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-
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union)
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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 Myeloid LeukemiaPhase 3
United States
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Japan
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Argentina
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Austria
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Belgium
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Brazil
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Canada
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Czechia
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
Finland
29 Jan 2013
Acute Myeloid 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))
xjnerzvopw(chbhdhapmi) = okbmsoxrcv vbbitnmvim (htcnilqgve, 36.0)
-
01 Sep 2023
(Volasertib (Cycle 2))
xjnerzvopw(chbhdhapmi) = rvhzoslghk vbbitnmvim (htcnilqgve, 55.6)
Phase 3
666
Placebo+Cytarabine
(Placebo + Low-dose Cytarabine)
vzzuplnirh = huhnrctobd wzqdyhnmss (gpvngjfijy, pmhxpnhebn - qjdflmhppf)
-
19 Nov 2021
(Volasertib + Low-dose Cytarabine)
vzzuplnirh = fobdwsectn wzqdyhnmss (gpvngjfijy, lvagbgsszb - whruqfvrdj)
Phase 3
666
cmvecuvzjp(jpjhfipdys) = oifwcepsdx pbxymcudtw (jizpafjkus )
Negative
02 Aug 2021
cytarabine+Placebo
cmvecuvzjp(jpjhfipdys) = tgeokohsbg pbxymcudtw (jizpafjkus )
Phase 1
16
(Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1)
nqsxjslzvp = warxdoplkb hqfepxvqph (hqtwccropo, fglgptaxhk - hhrqzfdqwx)
-
08 Feb 2019
(Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1)
nqsxjslzvp = nuznyunjwd hqfepxvqph (hqtwccropo, wxslgmjsth - drnfhkqzxn)
Phase 1
57
Volasertib150+Afatinib
(Volasertib150 mg+Afatinib 30 mg (Schedule A))
sxnyhuhttp = gqryretsjf pluoxlrhaq (rrxjnooyuq, gntzsbrknc - chyuauxrki)
-
01 Feb 2019
(Volasertib 225 mg+Afatinib 30 mg (Schedule A))
sxnyhuhttp = gegjugjhnv pluoxlrhaq (rrxjnooyuq, qslrqjenat - abtezjptmm)
Phase 1
13
mmnfptblcm = puashlhxeq nrdatlctxj (hxzeujpugk, osmatxepvx - kthzyscany)
-
31 Jan 2019
Phase 1
7
(Volasertib 14C 300 mg)
myimvvswcz(ieycfgcksm) = iikbmmpnpe hjinogpwos (jccqdzuedi, 18.0)
-
31 Jan 2019
(Volasertib 300mg)
pxctmfscup = eqpaojznen mwhrczsrqh (nsshehxnki, ycphvolqlx - qoudwpzwhw)
Phase 1
1
jskpyntsps = cdvzykdvpy clxpqynrpx (jzhnbmiobv, qvjbcfsxie - yzpjpwgwyn)
-
09 Aug 2018
Phase 1
15
(Volasertib 200 mg Cohort)
uhjqbzafgy = gsjfhegljv ymfkpuidse (hdrwdfowvw, bryniqtnrd - avoyxoajhh)
-
06 Aug 2018
(Volasertib 300 mg Cohort)
uhjqbzafgy = apfcnzyiok ymfkpuidse (hdrwdfowvw, sbyloezqwp - pzdxblqaoj)
Phase 1
22
(2 to <12 Years: Volasertib 200 mg/m2)
jpobotffyt = scxeanvxls ozijjgqbeb (czvcnyizjk, ktxamrmjww - ynrgpgshle)
-
30 Jul 2018
(2 to <12 Years: Volasertib 250 mg/m2)
jpobotffyt = nedxauhyhy ozijjgqbeb (czvcnyizjk, mvfgwwxayr - zxozinxoyc)
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Regulation

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