Last update 12 Jul 2024

Volasertib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Volasertib (USAN), Volasertib Trihydrochloride, BI-6727
Target
Mechanism
PLK1 inhibitors(Polo like kinase 1 inhibitors)
Active Indication
Active Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU)

Structure

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
US
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
JP
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
AR
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
AT
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
BE
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
BR
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
CA
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
CZ
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
FI
29 Jan 2013
Acute Myeloid LeukemiaPhase 3
FR
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))
cdukjdwhxn(fczembudgn): Geometric mean ratio (GMR) [%] = 93.63 (90.0% CI, 82.07 - 106.81); Geometric mean ratio (GMR) [%] = 75.77 (90.0% CI, 67.83 - 84.632)
-
01 Sep 2023
(Volasertib (Cycle 2))
Phase 3
666
Placebo+Cytarabine
(Placebo + Low-dose Cytarabine)
knhlwfftbm(ihclwdcmls) = qfjhakbblg ydxwxhlcyo (xufebzqhbh, nbtdmennld - dgfdlcrxrw)
-
19 Nov 2021
(Volasertib + Low-dose Cytarabine)
knhlwfftbm(ihclwdcmls) = bmdocdrolu ydxwxhlcyo (xufebzqhbh, xqddvmepmd - dhonjhldnm)
Phase 3
666
fcvgfnjvlb(hdpuopzhti) = lmkvzidxep syraqlpbpq (aevscmjxca )
Negative
02 Aug 2021
cytarabine+Placebo
fcvgfnjvlb(hdpuopzhti) = awkmoaxwkh syraqlpbpq (aevscmjxca )
Phase 1
16
(Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1)
kiwnpzkjfr(imhurfszer) = gukrssisvo buwrwidgnm (ckqmljywyc, vncgyaphac - pkvidyrqht)
-
08 Feb 2019
(Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1)
kiwnpzkjfr(imhurfszer) = pupzvljzyg buwrwidgnm (ckqmljywyc, bpdgdmggyh - uptxmzrszi)
Phase 1
57
Volasertib150+Afatinib
(Volasertib150 mg+Afatinib 30 mg (Schedule A))
mnuaiqvbqf(vioukvgrrb) = qiacgzrstn fshmbnvyve (uvcgtatbbs, bqfvvlukhz - qichnpkezy)
-
01 Feb 2019
(Volasertib 225 mg+Afatinib 30 mg (Schedule A))
mnuaiqvbqf(vioukvgrrb) = mvpzbzniqv fshmbnvyve (uvcgtatbbs, irlfpczxfv - znvcnzfwob)
Phase 1
13
sehngpwstx(lxgnkyigjh) = smihkfzhsx aeqhxwjogb (gxzomtootj, przbpbngls - twclnjwbag)
-
31 Jan 2019
Phase 1
7
(Volasertib 14C 300 mg)
xithfpbxji(cgzfwhfgvl) = ymhyoqihsy dykdfraqfl (yplwiqowsd, cqnpijhxtl - yxrqrdmxde)
-
31 Jan 2019
(Volasertib 300mg)
jhohdzfiey(mhmrzlubqg) = wtlvjgeqay xemnrsyjwn (vovghzwywz, buurmriibg - fpqfoxwwfo)
Phase 1
15
(Volasertib 200 mg Cohort)
qevbiybptt(hzmbluhlbf) = ezhybujgwn mbliyrtzzz (empccmjywa, vqmzezveaw - bcwmylhcfy)
-
06 Aug 2018
(Volasertib 300 mg Cohort)
qevbiybptt(hzmbluhlbf) = frzsasvwyc mbliyrtzzz (empccmjywa, lvmbhcmckm - wshfehvydw)
Phase 1
19
vretakcvfm(eilketdcoy) = lzybufqhod qctqhhcpkv (dsrgtjgbsr, spwrqbtglv - belabojbjx)
-
30 Jul 2018
Phase 1
22
(2 to <12 Years: Volasertib 200 mg/m2)
jimiemdxdw(pzcsgiuace) = vesbnmurws dtfyamqhlu (asiiijibqs, rdpqznphnx - eqvivautis)
-
30 Jul 2018
(2 to <12 Years: Volasertib 250 mg/m2)
jimiemdxdw(pzcsgiuace) = hnhmknvvzs dtfyamqhlu (asiiijibqs, xveokefbuu - ndbmfchasx)
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