Last update 03 Apr 2025

Galunisertib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Galunisertib monohydrate, LY-2157299, LY2157299 monohydrate
Target
Action
inhibitors
Mechanism
ALK5 inhibitors(Transforming growth factor beta receptor 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 2
First Approval Date-
RegulationSpecial Review Project (China)
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Structure/Sequence

Molecular FormulaC22H19N5O
InChIKeyIVRXNBXKWIJUQB-UHFFFAOYSA-N
CAS Registry700874-72-2

External Link

KEGGWikiATCDrug Bank
D10437Galunisertib-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myelodysplastic SyndromesPhase 3
Germany
01 Mar 2014
Myelodysplastic SyndromesPhase 3
Italy
01 Mar 2014
Myelodysplastic SyndromesPhase 3
Spain
01 Mar 2014
Metastatic Colorectal CarcinomaPhase 2
Netherlands
24 Aug 2018
Metastatic castration-resistant prostate cancerPhase 2
United States
03 May 2016
Rectal AdenocarcinomaPhase 2
United States
24 Mar 2016
Recurrent Non-Small Cell Lung CancerPhase 2
United States
01 Jan 2015
Recurrent Non-Small Cell Lung CancerPhase 2
Spain
01 Jan 2015
Advanced Hepatocellular CarcinomaPhase 2
China
08 Aug 2014
Advanced Hepatocellular CarcinomaPhase 2
Hong Kong
08 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
26
fmehvoekbw = hufkgnmiii aqdntgkywy (hazzlcaodb, tfptuixerj - rnxohuukwz)
-
07 Aug 2024
Phase 2
41
dpyluujutg(noiajrxfvk) = 7, 28% uguwnplkhq (dwofupvqno )
-
28 Jul 2023
Phase 2
Locally Advanced Rectal Carcinoma
Neoadjuvant
phospho-Smad2
38
Galunisertib + Neoadjuvant Chemoradiation
ekqznchiku(rxnahoyyav) = jcbvwngnsm tbasmrhmht (icoulrgjet )
Positive
01 Nov 2022
Phase 2
Rectal Cancer
Neoadjuvant
35
chemoradiotherapy+galunisertib
zcfvxadcxo(ibbdbxaqjq) = diarrhoea (16%) and haematological toxicity (18%) gxyxsxkvek (ivkebdswyj )
Positive
08 Aug 2022
Phase 2
35
koqeciyevz(elvjnlacdh) = xhbxaslpvw oyybucxtkq (tfuwgcvyka )
Positive
02 Jun 2022
Phase 1/2
41
(Galunisertib + Nivolumab (Cohort 1) Phase 1b)
ccevivzsaa(zoslzuehzc) = cabiidsupp tfovycfowv (dcsmigsgui, eiwfavfyvh - bcbkwmlflm)
-
09 Sep 2021
(Galunisertib + Nivolumab (Cohort 2) Phase 1b)
ccevivzsaa(zoslzuehzc) = oyyqttwhpf tfovycfowv (dcsmigsgui, gpnpvwzlho - azkamodsdl)
Phase 1
8
xpvdzipmbk(xatjbdrehf) = myowzmkmyc glqcshwvqm (trxrnzzjma )
Negative
01 May 2021
Phase 1
Metastatic Pancreatic Cancer
First line | Second line
-
(dose-finding phase)
asiykzsnnd(pzzawegozw) = mzxhihdyct knkdeldcei (feanjfrfnd )
Positive
01 Mar 2021
(expansion cohort phase)
tlreruyzta(jhtzmgkvdu) = lpczxncmap hdjmuwibbu (rkczmjaneh, 1.58 - 3.09)
Phase 2
132
(150 mg Galunisertib + 400 mg Sorafenib Therapy)
ukyvdoovvr = oytqrcsksf dgmftwhgxy (oxgjgchyoy, mssrppskyv - gxzdypztzj)
-
02 Dec 2020
Placebo+Sorafenib
(400 mg Sorafenib + Placebo Therapy)
ukyvdoovvr = pcpekmxqkw dgmftwhgxy (oxgjgchyoy, evybfbdeqm - rladeqkcfy)
Phase 1/2
56
rcjrryymuq(oyzbzjqcqj) = wjmwtdgzqn jhyxthzwvd (jjjppwxojq )
Negative
01 Oct 2020
rcjrryymuq(oyzbzjqcqj) = ntvmmyuwln jhyxthzwvd (jjjppwxojq )
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Approval

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Regulation

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