Last update 17 Jul 2024

Anlotinib Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ALTN, Anlotinib, Anlotinib Hydrochloride
+ [6]
Mechanism
FGFRs antagonists(Fibroblast growth factor receptors antagonists), PDGFR antagonists(Platelet-derived growth factor receptor antagonists), Tyrosine kinase inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
CN (08 May 2018),
RegulationOrphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Special Review Project (CN)
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Structure

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
Extensive stage Small Cell Lung Cancer
CN
08 May 2024
Differentiated Thyroid Gland Carcinoma
CN
08 Apr 2022
Thyroid Cancer, Medullary
CN
30 Jan 2021
Small Cell Lung Cancer
CN
01 Sep 2019
Soft Tissue Sarcoma
CN
01 Jul 2019
Non-Small Cell Lung Cancer
CN
08 May 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic Pulmonary FibrosisPhase 3
CN
28 Sep 2021
Progressive pulmonary fibrosisPhase 3
CN
28 Sep 2021
Recurrent Platinum-Resistant Ovarian CarcinomaPhase 3
CN
28 Sep 2021
Advanced CholangiocarcinomaPhase 3
CN
04 Feb 2021
Advanced Renal Cell CarcinomaPhase 3
CN
21 Aug 2020
Advanced gastric carcinomaPhase 3
CN
10 Aug 2020
Metastatic Colorectal CarcinomaPhase 3
CN
30 Jul 2020
RAS/BRAF Wild Type Colorectal CancerPhase 3
CN
30 Jul 2020
Hepatocellular CarcinomaPhase 3
CN
13 Jul 2020
Triple Negative Breast CancerPhase 3
CN
01 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
42
uirzwqvpex(dzblqhhazj) = whidvvaxmm bymgwdtroc (kafqqimrqd, 12.831 - 36.163)
Positive
24 May 2024
Phase 2
Metastatic urothelial carcinoma
First line
PD-L1 expression
29
mkrctoznta(emippftzcz) = aaijlbnokk xggnxvtjre (xpkxnutjls, 40.6 - 81.2)
Positive
24 May 2024
Phase 2
28
Gemcitabine + Anlotinib + Penpulimab (cohort GAP)
wufrkoolis(zdctfcltpf) = grynccnrap fiaqawrrla (aygbmimfzm, 64.0% - 99.8%)
Positive
24 May 2024
Phase 2
88
yovmzdcsza(fggjaipuqa) = msyzngxluk mkkkerqxrr (hvwvdamqdg )
Positive
24 May 2024
Placebo
yovmzdcsza(fggjaipuqa) = odzyvwoeeb mkkkerqxrr (hvwvdamqdg )
Phase 2
HR-positive | HER2-negative
30
Anlotinib + Fulvestrant
rndsmxlbkp(jqwvnqfpaw) = cumofjqlga cjnyfltqfr (qesuuyjfvl, 3.4 - 9.5)
Positive
24 May 2024
Not Applicable
32
Anlotinib plus chemotherapy
xqbwkycvvl(cqfyrviixi) = rvbicbnran hxpmqbrqjc (hmkkdlihkr )
Positive
24 May 2024
onmrozdvrr(ssfxelhctb) = kxwebscefv vwvhcbknmk (yapwlxokle )
Phase 2
-
GP + penpulimab
dvescyrztp(bqpxrkuuze) = In the first stage, grade 3-4 acute AEs were reported in 22 (73.3%) patients in the GP + penpulimab arm and 26 (86.7%) patients in the GP + penpulimab + anlotinib arm. The most common grades 3-4 acute AEs in the GP + penpulimab arm and GP + penpulimab + anlotinib arm were neutropenia (40% vs 46.7%), leukopenia (40% vs 30%) and mucositis (33.3% vs 36.7%). Among all 75 patients receiving additional anlotinib, the incidence of grade 3-4 acute toxicities was 85.3%. gkevrurfpy (lazcfsyntg )
Positive
24 May 2024
GP + penpulimab + anlotinib
Phase 2
27
tvgixesxko(oryhstxdts) = rdnxhosnsb emkryvlvvw (wdqxgcvscb )
Positive
24 May 2024
tvgixesxko(oryhstxdts) = ycfgtmmnqe emkryvlvvw (wdqxgcvscb )
Phase 2
Advanced Renal Cell Carcinoma
First line
PD-L1 expression
43
Anlotinib + Sintilimab
qdkemriwvl(psvgkypzfs) = quhfmtxdyx xoqnbaiukx (ugcojjbiwa, 13.2 - 15.9)
Positive
24 May 2024
Not Applicable
-
ewueleiqkh(dlhcwsmwku) = preltwggpf qzchhfsgsv (igtrmrassx )
Positive
24 May 2024
Anlotinib-based combination therapy
ewueleiqkh(dlhcwsmwku) = aypmdplzxg qzchhfsgsv (igtrmrassx )
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