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 |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date China (08 May 2018), |
RegulationOrphan Drug (United States), Conditional marketing approval (China), Special Review Project (China), Priority Review (China) |
Molecular FormulaC23H23ClFN3O3 |
InChIKeyGTAUHBAHFJIAQT-UHFFFAOYSA-N |
CAS Registry1360460-82-7 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Lung Non-Small Cell Squamous Carcinoma | NDA/BLA | China | 23 Apr 2025 | |
Non-small cell lung cancer stage III | NDA/BLA | China | 23 Apr 2025 | |
Hepatocellular Carcinoma | NDA/BLA | China | 21 Nov 2024 | |
Small cell lung cancer limited stage | Phase 3 | China | 01 Sep 2024 | |
Primary peritoneal carcinoma | Phase 3 | United States | 06 Apr 2022 | |
Primary peritoneal carcinoma | Phase 3 | United States | 06 Apr 2022 | |
Primary peritoneal carcinoma | Phase 3 | China | 06 Apr 2022 | |
Primary peritoneal carcinoma | Phase 3 | China | 06 Apr 2022 | |
Primary peritoneal carcinoma | Phase 3 | Italy | 06 Apr 2022 | |
Primary peritoneal carcinoma | Phase 3 | Italy | 06 Apr 2022 |
Not Applicable | 210 | yjyutjdiof(asuoifvgps) = pyvgfmuugw bpqqjwuyrg (qfxbxtgtab ) View more | Positive | 03 Jul 2025 | |||
(Other treatment methods not including anti-angiogenic TKIs) | yjyutjdiof(asuoifvgps) = ccozrqazkv bpqqjwuyrg (qfxbxtgtab ) View more | ||||||
Not Applicable | Gastrointestinal Neoplasms RGC32 | TGFβ1 pathway | 256 | Anlotinib monotherapy or combination group | ftibuyvpqo(ragszsulrp) = srqusbykhs vrvtrhkvuv (ryvluspmrh, 2.4 - 8.1) | Positive | 03 Jul 2025 | |
Other treatments without anti-angiogenic TKIs group | ftibuyvpqo(ragszsulrp) = tcqnklepci vrvtrhkvuv (ryvluspmrh, 2.8 - 4.8) | ||||||
Phase 2 | Extensive stage Small Cell Lung Cancer Second line | 37 | wydiwhuojf(zdrylhdmql) = qrxzzyifon rcvedklpth (fhrgbuvgee ) View more | Positive | 01 Jul 2025 | ||
Not Applicable | - | Anlotinib + Camrelizumab + Chemotherapy (TCAC group) | ycfmsdxflm(lbolrnhiud) = ldvaypmvxd tklrumksrl (wxhkfvudmn ) View more | - | 01 Jul 2025 | ||
Camrelizumab + Chemotherapy (TCC group) | ycfmsdxflm(lbolrnhiud) = rpxorksvus tklrumksrl (wxhkfvudmn ) View more | ||||||
Phase 2 | 46 | Anlotinib + Benmelstobart | yolvendmzy(pxbsczxiut) = inxcduifkv mzliwqhdta (cowxtqhbfv, 41.1 - 71.1) View more | Positive | 11 Jun 2025 | ||
Anlotinib + Benmelstobart (TP53+/FAT1+/NOTCH3-) | yolvendmzy(pxbsczxiut) = wtachdzqgw mzliwqhdta (cowxtqhbfv ) View more | ||||||
Phase 2 | 29 | fbyfftnnvr(vtjedldqbu) = bnsbekohdp brytmfijhe (hcguwweqxj, 49.0% - 85.0) | Positive | 01 Jun 2025 | |||
NCT04959500 (ASCO2025) Manual | Phase 2 | Glioblastoma First line | 153 | zdtxbfmeit(mlpjjvmymt) = aacnkhywsl sdriztqeos (krobkeiuvu, 9.10 - 11.56) Met View more | Positive | 30 May 2025 | |
placebo | zdtxbfmeit(mlpjjvmymt) = zvkekgxwza sdriztqeos (krobkeiuvu, 3.58 - 7.69) Met View more | ||||||
Phase 3 | Triple Negative Breast Cancer First line | 147 | wuevxwytzt(bmkhtmpqds) = wvzqxvsydf vmtcjarsrh (nwsyqdoahu ) View more | Positive | 30 May 2025 | ||
wuevxwytzt(bmkhtmpqds) = rotwyhhbtt vmtcjarsrh (nwsyqdoahu ) View more | |||||||
Phase 3 | 528 | seopybtgfg(jomcspkutg) = valrfftfvt zywbjumtlo (qrlsttxhuk, 9.2 - 12.6) Met View more | Positive | 30 May 2025 | |||
seopybtgfg(jomcspkutg) = nrbjurkbaw zywbjumtlo (qrlsttxhuk, 5.8 - 9.5) Met View more | |||||||
Not Applicable | 81 | kzpbhwayod(quhzakeomj) = iiffbaxuox hpiufnxtgy (cdvbopsxxq ) | Positive | 30 May 2025 |