Last update 27 Jun 2025

Anlotinib Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALTN, Anlotinib, Anlotinib Hydrochloride
+ [6]
Action
antagonists, inhibitors
Mechanism
FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), Tyrosine kinase inhibitors
Originator Organization
License Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (United States), Conditional marketing approval (China), Special Review Project (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC23H23ClFN3O3
InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N
CAS Registry1360460-82-7

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Renal Cell Carcinoma
China
13 May 2025
Unresectable Renal Cell Carcinoma
China
13 May 2025
Endometrial Carcinoma
China
22 Nov 2024
Extensive stage Small Cell Lung Cancer
China
08 May 2024
Differentiated Thyroid Gland Carcinoma
China
08 Apr 2022
Thyroid Cancer, Medullary
China
30 Jan 2021
Small Cell Lung Cancer
China
01 Sep 2019
Soft Tissue Sarcoma
China
01 Jul 2019
Non-Small Cell Lung Cancer
China
14 May 2018
Locally Advanced Lung Non-Small Cell Carcinoma
China
08 May 2018
metastatic non-small cell lung cancer
China
08 May 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell Squamous CarcinomaNDA/BLA
China
23 Apr 2025
Non-small cell lung cancer stage IIINDA/BLA
China
23 Apr 2025
Hepatocellular CarcinomaNDA/BLA
China
21 Nov 2024
Small cell lung cancer limited stagePhase 3
China
01 Sep 2024
Primary peritoneal carcinomaPhase 3
United States
06 Apr 2022
Primary peritoneal carcinomaPhase 3
United States
06 Apr 2022
Primary peritoneal carcinomaPhase 3
China
06 Apr 2022
Primary peritoneal carcinomaPhase 3
China
06 Apr 2022
Primary peritoneal carcinomaPhase 3
Italy
06 Apr 2022
Primary peritoneal carcinomaPhase 3
Italy
06 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Advanced Esophageal Squamous Cell Carcinoma
First line
TP53 Mutation | FAT1 Mutation
46
Anlotinib + Benmelstobart
mqzkaiwudj(wxrlwbwvib) = utvfkzzehy jbcnyzrpks (gwqftplaij, 41.1 - 71.1)
Positive
11 Jun 2025
Anlotinib + Benmelstobart
(TP53+/FAT1+/NOTCH3-)
mqzkaiwudj(wxrlwbwvib) = innlscykcl jbcnyzrpks (gwqftplaij )
Phase 3
147
zckwtfjtjr(cdbpuijrfr) = corqbtagfs gtoqypxgxr (qdlqqnxxmd )
Positive
30 May 2025
zckwtfjtjr(cdbpuijrfr) = buctfpvpks gtoqypxgxr (qdlqqnxxmd )
Phase 2
Glioblastoma
First line
153
hermrnuiwo(qdokhxlcxe) = iscbqewzdq gpnmrzbydx (wxrwrzmgig, 9.10 - 11.56)
Met
Positive
30 May 2025
placebo
hermrnuiwo(qdokhxlcxe) = vgkkcdlior gpnmrzbydx (wxrwrzmgig, 3.58 - 7.69)
Met
Phase 3
528
opkzjvibnc(ptjydglfpn) = hozbsogpsh zcjshkxeyx (rvtjbmyyku, 9.2 - 12.6)
Met
Positive
30 May 2025
opkzjvibnc(ptjydglfpn) = tnsufebftm zcjshkxeyx (rvtjbmyyku, 5.8 - 9.5)
Met
Phase 2
20
kcwzbvhbhg(cmuodkeuub) = mrpnptatua xoyltuetyq (kdgtcfvaii, 31.5 - 76.9)
Positive
30 May 2025
Phase 3
111
Catequentinib Hydrochloride (AL3818)
nqmjzfesqd(dtkvurdqob) = kkitqzqqjq ylbgyxvmvo (hwyjfmxmfi )
Positive
30 May 2025
Placebo
nqmjzfesqd(dtkvurdqob) = bskxdgmesu ylbgyxvmvo (hwyjfmxmfi )
Not Applicable
252
Anlotinib + Radiotherapy
ntsghpwori(vcrchvloww) = eiikzyifyx lbktcuouvd (tbexrjebht, 25.9 - 72.2)
Positive
30 May 2025
Radiotherapy ± Chemotherapy
ntsghpwori(vcrchvloww) = ejpqotocnc lbktcuouvd (tbexrjebht, 44.0 - 64.1)
Phase 2
19
Anlotinib + Tislelizumab + Nab-paclitaxel + Anthracycline
jpmoacudpi(zyedlacqgo) = lvvwussbdq yzfthldzik (tvzwbhebys, 46 - 84.6)
Positive
30 May 2025
Phase 3
Soft Tissue Sarcoma
First line | Maintenance
272
swpmxtyhth(rbvjbpalah) = ljfirwxdoq abosyhlkwv (xwwxxadbbu, 0.21 - 0.44)
Positive
30 May 2025
swpmxtyhth(rbvjbpalah) = natslhvaae abosyhlkwv (xwwxxadbbu )
Phase 2
20
sfeqhtvimn(gucfmbubxb) = vjjddkrtcb ztscjrmufj (watwnnlkaw, 36.1% - 80.9)
Positive
30 May 2025
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