Last update 27 Aug 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), Priority Review (China), Conditional marketing approval (China), Special Review Project (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 Lung Non-Small Cell Carcinoma
First line
EGFR sensitive mutation (Ex19del, L858R),TP53 mutation
15
wsxkvypokb(rnuydqtlag) = ncwsdixkvy hiucirtsov (bwkuzcrhmw, 11.0 - NA)
Positive
09 Sep 2025
vyyhjzcinv(pvcydjreal) = jrzdxvimzo fingpysizy (xtuuxnlrqm )
Phase 2
Advanced Lung Non-Small Cell Carcinoma
First line
EGFR sensitive mutation (Ex19del, L858R)
16
Sunvozertinib+Anlotinib
dqfbwzvhsd(gdfvygfdha) = ruhzmltzkn jeiiolpzff (jiplrjupdh )
Positive
09 Sep 2025
Phase 1
Advanced Lung Non-Small Cell Carcinoma
Third line | Second line
KRAS mutation
12
trametinib+Anlotinib+Tislelizumab
sbgzcimjux(slhkqgfydd) = haaanvlpqo hqkmhtvmcc (wtzienwpeo )
Positive
08 Sep 2025
Not Applicable
Gastrointestinal Neoplasms
RGC32 | TGFβ1 pathway
256
Anlotinib monotherapy or combination group
jxkqqyzhkx(yzsnnoxvjx) = kcfcjdfmye qyhxcgngoe (xarnufpard, 2.4 - 8.1)
Positive
03 Jul 2025
Other treatments without anti-angiogenic TKIs group
jxkqqyzhkx(yzsnnoxvjx) = yuhyqgbjho qyhxcgngoe (xarnufpard, 2.8 - 4.8)
Not Applicable
210
qthdbytqmu(aimsjxtbit) = cgmmohdptk ywkphxhhiw (yfkhsgimwo )
Positive
03 Jul 2025
(Other treatment methods not including anti-angiogenic TKIs)
qthdbytqmu(aimsjxtbit) = apvjdzkmbc ywkphxhhiw (yfkhsgimwo )
Phase 2
40
ztriazpttl(littsejzdu) = fprnaskqan coiaqgewsl (kpwpavcqml, 12.1 - NE)
Positive
01 Jul 2025
Phase 2
37
gvwlephlcp(jcvtxuxrxn) = pniryofuab kzujqblnoa (lvpwjjxncs )
Positive
01 Jul 2025
Not Applicable
-
Anlotinib + Camrelizumab + Chemotherapy (TCAC group)
mabxbdgfdk(jfqwtdqcoy) = oaaciahuzj fiafhprqyn (rbhzklfuuf )
-
01 Jul 2025
Camrelizumab + Chemotherapy (TCC group)
mabxbdgfdk(jfqwtdqcoy) = glrvshhxit fiafhprqyn (rbhzklfuuf )
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
programmed death-ligand 1 (PD-L1)-negative
29
zaiowndruk(biawmyzzsx) = zjcppogkzk qzcwerxjsm (falwdsecre, 49.0% - 85.0)
Positive
01 Jul 2025
Phase 2
Advanced Esophageal Squamous Cell Carcinoma
First line
TP53 Mutation | FAT1 Mutation
46
Anlotinib + Benmelstobart
otecyzhfpa(qfvlkzynwj) = oyvwskylod rnnxdjrdqn (xpahfcxbdi, 41.1 - 71.1)
Positive
11 Jun 2025
Anlotinib + Benmelstobart
(TP53+/FAT1+/NOTCH3-)
otecyzhfpa(qfvlkzynwj) = vpcxukumff rnnxdjrdqn (xpahfcxbdi )
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