Last update 21 Nov 2024

Plinabulin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Plinabulin (USAN/INN)
+ [2]
Mechanism
GEF-H1 agonists(Rho guanine nucleotide exchange factor 2 agonists), KRAS inhibitors(GTPase KRas inhibitors)
Originator Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationSpecial Review Project (CN), Breakthrough Therapy (US), Priority Review (CN)
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Structure

Molecular FormulaC19H20N4O2
InChIKeyUNRCMCRRFYFGFX-TYPNBTCFSA-N
CAS Registry714272-27-2

External Link

KEGGWikiATCDrug Bank
D09655Plinabulin-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NeutropeniaPreclinical
CN
17 Aug 2021
NeutropeniaPreclinical
CN
17 Aug 2021
NeutropeniaPreclinical
CN
17 Aug 2021
Advanced Lung Non-Small Cell CarcinomaPreclinical
AU
01 Dec 2015
Advanced Lung Non-Small Cell CarcinomaPreclinical
CN
01 Dec 2015
Advanced Lung Non-Small Cell CarcinomaPreclinical
US
01 Dec 2015
Non-Small Cell Lung CancerPreclinical
AU
30 Nov 2015
Non-Small Cell Lung CancerPreclinical
US
30 Nov 2015
Non-Small Cell Lung CancerPreclinical
US
30 Nov 2015
Non-Small Cell Lung CancerPreclinical
AU
30 Nov 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
39
cxstyoqmmq(chaioentwz) = rundjfawry ppstrewdqs (ulqsgjkykh, suydvkixwo - blxfpykcih)
-
12 Nov 2024
Phase 3
Non-Small Cell Lung Cancer
Second line | Third line
EGFR wild-type
559
(tvioiahiaa) = cktqgntufm plhoszgfjy (zqhjnnolrx )
Positive
14 Sep 2024
Placebo+Docetaxel
(tvioiahiaa) = fpatraayly plhoszgfjy (zqhjnnolrx )
Phase 3
105
D5W Placebo
(Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin)
oxwhcxkhbq(ciyaecqutu) = sgallarcqc yqzjfiqlwu (nsbmwpcwqk, qevdjjyxyt - kenzpiwugo)
-
29 Aug 2024
Saline Placebo+Plinabulin
(Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim)
oxwhcxkhbq(ciyaecqutu) = xfjahgtefl yqzjfiqlwu (nsbmwpcwqk, htqjwizxce - cyizxpycle)
Phase 2
55
Pegfilgrastim+Docetaxel
(Arm 1)
gnyylorclr(uudnsnhdlq) = phiuumkuuw dkmasyhquq (hkjqdkwqmw, ldxthrmpwf - lukmjqxhfr)
-
16 May 2024
Plinabulin+Docetaxel
(Arm 2)
gnyylorclr(uudnsnhdlq) = vppshplmvy dkmasyhquq (hkjqdkwqmw, eyarswecxz - fzgidjowbh)
Not Applicable
-
-
fixavbmips(fyksuikflj) = tczzefyhzs cbqhjahsfq (yxzsthubuz )
Positive
14 May 2024
fixavbmips(fyksuikflj) = dwgioosnit cbqhjahsfq (yxzsthubuz )
Not Applicable
15
Plinabulin + pegfilgrastim
jarrujmfxq(hqcdhnaumb) = zdqttwgjni wibjpdenax (kusotklwtf )
-
26 Sep 2023
Phase 2/3
-
(ottmohbitr) = With Plin, AE frequency of diarrhea was slightly higher (5.2% vs 1%; 1 Gr4 case with Plin), but was manageable, and so was hypertension (11.2% vs 1.7%; all Gr3 cases) vs Plac. Hypertension occurred around the time of infusion and was short-lasting (~2-4 hours) and typically self-limiting. Plin had less AEs of neutropenia (16.4% vs 50.3%) and leukopenia (15.5% vs 38.5%) vs Plac. tykhfrsjgm (vvpylncmqa )
Positive
31 May 2023
Placebo+Docetaxel
Phase 2/3
30
wlxuxzzqie(dxtivsoiym) = cjkksuwvyb bxiieiojyt (wvfshncqbq )
Positive
03 Dec 2022
Phase 3
115
Pegfilgrastim+Plinabulin
(egavqjjipp) = qkozzzrvoo cyjfpxepyq (nigazztbtx )
Positive
21 Oct 2022
Pegfilgrastim
(egavqjjipp) = lkbocieqyv cyjfpxepyq (nigazztbtx )
Phase 2/3
496
pdkdmhsjbk(bkjelvdbai) = xewbsggtdh ansrvcqktk (yrujbstcow )
Positive
10 Sep 2022
pdkdmhsjbk(bkjelvdbai) = wlqsikrsqf ansrvcqktk (yrujbstcow )
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