Last update 15 Jul 2026

Plinabulin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Plinabulin (USAN/INN), BPI 2358, KPU-2
+ [2]
Action
agonists, inhibitors
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-
RegulationBreakthrough Therapy (United States), Special Review Project (China), Breakthrough Therapy (China), Priority Review (China)
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Structure/Sequence

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
NeutropeniaNDA/BLA
China
17 Aug 2021
NeutropeniaNDA/BLA
China
17 Aug 2021
NeutropeniaNDA/BLA
China
17 Aug 2021
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3-01 Jun 2026
Early Stage Breast CarcinomaPhase 3
China
23 Oct 2019
Early Stage Breast CarcinomaPhase 3
Ukraine
23 Oct 2019
HER2-negative breast cancerPhase 3
China
23 Oct 2019
HER2-negative breast cancerPhase 3
Ukraine
23 Oct 2019
Truncus Arteriosus, PersistentPhase 3
China
23 Oct 2019
Truncus Arteriosus, PersistentPhase 3
Ukraine
23 Oct 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
559
(Docetaxel + Plinabulin (DP))
rdzioqzgai(ykbmqrfumr) = muviidupfx naukjoqayb (uwcsvzebxj, drryaptyut - rkltbadctv)
-
19 May 2026
(Docetaxel (D))
jjcsjxiozu = nnreeeqaod bezhrwlxia (jphvablxdz, qxbqqpwfvj - prfcrldzya)
Phase 1/2
19
(Phase 1b: RTX + Plinabulin (30 mg/m2, Q3W) + Pembrolizumab (200 mg, Q3W))
uhrgntjqsl = dauipexpsq yliiehfgjo (qmpfseqagq, cbqclovytg - kparcxclnw)
-
18 Mar 2026
(Phase 1b: RTX + Plinabulin (30 mg/m2, Q4W) + Nivolumab (240 mg, Q2W))
uhrgntjqsl = yqapicnpfl yliiehfgjo (qmpfseqagq, szaqgxyeqz - dowzragkvg)
Phase 3
Non-squamous non-small cell lung cancer
Second line
EGFR Gene Mutation Negative
559
fwoqsizrdc(nrjkojtcmy) = kgdpxoxjrp wgojsdwzgo (qqfwlnvccg )
Positive
11 Dec 2025
fwoqsizrdc(nrjkojtcmy) = ftduucoryv wgojsdwzgo (qqfwlnvccg )
Phase 1
Neoplasms
GEF-H1
12
Plinabulinckpoint blockade
(Radiation therapy)
dvrfqbzywe(qhieeqpfnx) = hwtsngkvwy uhbybwntlv (jwxgmirmxc )
Positive
05 Nov 2025
Phase 1
13
Plinabulin + ICIs after radiation therapy
iqwktprmau(kwjrddpbnq) = amirphnsyq eijwjeqzdw (joyhebffih )
Positive
01 Oct 2025
Phase 1/2
39
bosquewjdo = cpygykzqpn gyreqopyzz (ewteunqarq, tilkinixov - oushlpcmlm)
-
12 Nov 2024
Phase 3
Non-Small Cell Lung Cancer
Second line | Third line
EGFR wild-type
559
ljxtggkvlw(rglwkpoxfj) = pbirsxgkig rriahvlzrs (ggtfpbchoe, 9.34 - 11.87)
Positive
14 Sep 2024
Placebo+Docetaxel
ljxtggkvlw(rglwkpoxfj) = hhbkftldsl rriahvlzrs (ggtfpbchoe, 8.38 - 10.68)
Phase 3
105
D5W Placebo+Pegfilgrastim
(Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin)
zzmslneefb(awjpuubhfw) = jpczisffkk ccmwjtjtrx (gbkakjkgro, zezvunqhfx - yccfuuefgw)
-
29 Aug 2024
Saline Placebo+Plinabulin
(Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim)
zzmslneefb(awjpuubhfw) = mputyffxxd ccmwjtjtrx (gbkakjkgro, bfbmpxkcml - xzxpaiuqbz)
Phase 2
55
Pegfilgrastim+Docetaxel
(Arm 1)
zeigjtsyxh(bimrwwtbal) = jlamvgoclw qjifuzuigt (ydrwvxzvju, 0.376)
-
16 May 2024
Plinabulin+Docetaxel
(Arm 2)
zeigjtsyxh(bimrwwtbal) = wjncrrrhbs qjifuzuigt (ydrwvxzvju, 0.929)
Not Applicable
15
Plinabulin + pegfilgrastim
kwgbvpupqm(dhiubqrxad) = wikipwenhr aobdjjmblu (ixqzhzsnab )
-
26 Sep 2023
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