Drugs / Firmonertinib
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Firmonertinib

Small molecule targets EGFR via inhibition

Developed for
non-small cell lung carcinoma · lung adenocarcinoma · lung cancer · malignant leptomeningeal tumor · malignant tumor of meninges · metastatic malignant neoplasm in the brain · neoplastic meningitis · breast cancer
+1 more · pleural neoplasm
Investigated by
Allist Pharmaceuticals, Inc. · ArriVent BioPharma, Inc. · Peking University Cancer Hospital & Institute · Sun Yat-sen University · Tianjin Medical University Cancer Institute and Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
+57 more · Shanghai Chest Hospital · Shanghai Pulmonary Hospital, Shanghai, China · First Affiliated Hospital of Zhejiang University · Fudan University · Henan Cancer Hospital · Hunan Province Tumor Hospital · Jiangsu Province Nanjing Brain Hospital · Peking Union Medical College Hospital · Second Affiliated Hospital of Nanchang University · Tang-Du Hospital · Anhui Provincial Cancer Hospital · Army Specialty Medical Center · Beijing CSCO-Allist Cancer Research Foundation · Beijing Pearl Biotechnology Limited Liability Company · Changhai Hospital · Chongqing University Cancer Hospital · Fujian Medical University Union Hospital · Fujian Provincial Hospital · Fuzhou General Hospital · GeneCast Biotechnology Co., Ltd. · Guangzhou Burning Rock Medical Examination Institute Co., Ltd. · Guangzhou University of Traditional Chinese Medicine · Hunan Cancer Hospital · InxMed (Shanghai) Co., Ltd. · Jialei Wang · Jiangmen Central Hospital · Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Juan LI, MD · Li-kun Chen · MediLink Therapeutics (Suzhou) Co., Ltd. · Minghui Pharmaceutical (Hangzhou) Ltd · Nanfang Hospital, Southern Medical University · Ningbo No. 1 Hospital · Peking Union Medical College · Peking University People's Hospital · Qiming Wang · RemeGen Co., Ltd. · Ruijin Hospital · Second Affiliated Hospital of Wannan Medical College · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Allist Pharmaceutical Technology Co., Ltd. · Shanghai Allist Pharmaceuticals Co.,Ltd. · Shanghai Changzheng Hospital · Shanghai Minhang Central Hospital · Shanghai Zhongshan Hospital · Shanghai Zhongshan Hospital Qingpu Branch · Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Taizhou Hospital · The First Affiliated Hospital of Bengbu Medical University · The First Affiliated Hospital of Henan University of Science and Technology · The First Affiliated Hospital of Nanchang University · The First People's Hospital of Changzhou · The General Hospital of Eastern Theater Command · The Second Affiliated Hospital of Chongqing Medical University · Tongji University · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Xuhui Central Hospital, Shanghai

Trials 76 · started per year

today
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20172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07458919 Mar 2026 → Oct 2030 expected lung cancer Fuzhou General Hospital Not yet recruiting No outcome recorded
Phase 17 trials
Phase 1 NCT06868732 Apr 2025 → Jun 2028 expected non-small cell lung carcinoma Jiangsu Alphamab Biopharmaceuticals Co., Ltd Recruiting No outcome recorded
Phase 1 NCT05364073 Jun 2022 → Jun 2025 overdue non-small cell lung carcinoma ArriVent BioPharma, Inc. Active not recruiting No outcome recorded
Phase 1 NCT04958967 Oct 2021 → May 2022 non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Withdrawn No outcome recorded
Phase 1 NCT04858958 Aug 2020 → Dec 2024 overdue non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 1 NCT03941340 Apr → Sep 2019 Allist Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT03926182 Feb → Apr 2019 Allist Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT02973763 Dec 2016 → Feb 2021 non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Terminated No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT07655622 Jul 2026 → Dec 2027 expected non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University Recruiting No outcome recorded
Phase 1/2 NCT07169994 Sep 2025 → Sep 2026 expected breast cancer, non-small cell lung carcinoma MediLink Therapeutics (Suzhou) Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT07229599 May 2025 → May 2029 expected lung cancer Minghui Pharmaceutical (Hangzhou) Ltd Recruiting No outcome recorded
Phase 1/2 NCT07087223 Apr 2025 → Apr 2027 expected non-small cell lung carcinoma Peking University Cancer Hospital & Institute Recruiting No outcome recorded
Phase 1/2 NCT05994131 Jul 2023 → Jul 2026 overdue non-small cell lung carcinoma InxMed (Shanghai) Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT05079022 Oct 2021 → Mar 2023 lung adenocarcinoma Peking University People's Hospital Unknown No outcome recorded
Phase 247 trials
Phase 2 NCT07622186 Jul 2026 → Dec 2028 expected non-small cell lung carcinoma Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT07482605 Jul 2026 → Oct 2027 expected non-small cell lung carcinoma, pleural neoplasm Jiangmen Central Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07314216 Jun 2026 → Dec 2030 expected non-small cell lung carcinoma Hunan Cancer Hospital Recruiting No outcome recorded
Phase 2 NCT07661173 Jun 2026 → Mar 2029 expected non-small cell lung carcinoma Anhui Provincial Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07622706 May 2026 → May 2028 expected non-small cell lung carcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07637448 May 2026 → Mar 2029 expected non-small cell lung carcinoma Nanfang Hospital, Southern Medical University Recruiting No outcome recorded
Phase 2 NCT07517640 Apr 2026 → Feb 2028 expected non-small cell lung carcinoma Shanghai Pulmonary Hospital, Shanghai, China Not yet recruiting No outcome recorded
Phase 2 NCT07548060 Feb 2026 → Jan 2028 expected non-small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 2 NCT07298148 Jan 2026 → Dec 2030 expected non-small cell lung carcinoma Peking University Cancer Hospital & Institute Not yet recruiting No outcome recorded
Phase 2 NCT07304739 Dec 2025 → Dec 2028 expected non-small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05209256 Mar 2022 → Jan 2024 non-small cell lung carcinoma The First Affiliated Hospital of Henan University of Science and Technology Unknown No outcome recorded
Phase 38 trials
Phase 3 NCT07185997 Dec 2025 → Feb 2029 expected non-small cell lung carcinoma ArriVent BioPharma, Inc. Recruiting No outcome recorded
Phase 3 NCT07010419 May 2025 → Oct 2028 expected non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT06956001 Nov 2024 → Dec 2027 expected non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT06970639 Sep 2024 → Mar 2029 expected Allist Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT06674343 Jul 2024 → Dec 2026 expected non-small cell lung carcinoma Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 3 NCT05607550 Jun 2023 → Aug 2025 overdue non-small cell lung carcinoma ArriVent BioPharma, Inc. Active not recruiting No outcome recorded
Phase 3 NCT04853342 Jun 2021 → Jan 2026 overdue non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 3 NCT03787992 May 2019 → Sep 2021 overdue Allist Pharmaceuticals, Inc. Active not recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT07092202 Apr 2025 → May 2027 expected malignant leptomeningeal tumor, non-small cell lung carcinoma Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase not applicable5 trials
NCT07348965 Mar 2026 → Sep 2028 expected malignant tumor of meninges, non-small cell lung carcinoma Guangzhou University of Traditional Chinese Medicine Recruiting No outcome recorded
NCT07398599 Feb 2026 → Dec 2027 expected malignant leptomeningeal tumor, non-small cell lung carcinoma Second Affiliated Hospital of Nanchang University Recruiting No outcome recorded
NCT06969781 May 2025 → Dec 2028 expected non-small cell lung carcinoma Shanghai Chest Hospital Not yet recruiting No outcome recorded
NCT06643000 Dec 2024 → Mar 2025 overdue malignant tumor of meninges, non-small cell lung carcinoma Henan Cancer Hospital Recruiting No outcome recorded
NCT03127449 Jun 2017 → May 2021 non-small cell lung carcinoma Allist Pharmaceuticals, Inc. Terminated No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT05821933 Background Sep 2023 → Sep 2025 overdue non-small cell lung carcinoma RemeGen Co., Ltd. Recruiting No outcome recorded
Phase 23 trials
Phase 2 NCT07365410 Comparator Jan → May 2026 overdue metastatic malignant neoplasm in the brain, non-small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06668103 Background Nov 2024 → Dec 2027 expected non-small cell lung carcinoma Abbisko Therapeutics Co, Ltd Recruiting No outcome recorded
Phase 2 NCT06452433 Background Jun 2024 → Dec 2027 expected non-small cell lung carcinoma Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT04401059 Comparator Nov 2020 → Sep 2025 adenocarcinoma, non-small cell lung carcinoma Tian Xie Unknown No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 84 sources stand behind the page.

FieldValueCited text
Known as firmonertinib “furmonertinib (firmonertinib) at 2 dose levels” NCT05607550
11

“high-dose firmonertinib (240 mg, daily)” NCT06971406

NCT06956001

NCT07661173

NCT07182708

NCT06890182

NCT07622706

NCT06668103

NCT07185997

NCT07298148

NCT07010419

NCT07314216

Known as Aifisha “Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000
Known as alflutinib “Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000
4

NCT03452592

NCT03127449

NCT02973763

NCT05209256

Known as Alflutinib mesilate ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258
Known as Alflutinib Mesylate Alflutinib Mesylate Tablets (AST2818) in Healthy Male Volunteers” NCT03926182
2

“Orally Administered \[14C\]-Alflutinib Mesylate (AST2818)” NCT03941340

NCT03787992

Known as AST-2818 MESYLATE ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258
Known as AST2818 “Furmonertinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both sensitising EGFR and EGFR Thr790Met (T790M)...” PMID 33780662 Mar 2021
6

“Furmonertinib (brand name: Aifisha, formerly known as alflutinib/AST2818) is a third-generation EGFR TKI independently developed by Shanghai Allist Pharmaceuticals.” NCT06643000

“A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo” NCT04853342

“Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution.” NCT06945705

“Alflutinib Mesylate (AST2818)” NCT03787992

NCT03926182

NCT03941340

Known as Firmonertinib Mesilate Firmonertinib Mesilate Tablets” NCT06956001
Known as Firmonertinib Mesilate Tablets Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.” NCT07182708
Known as firmonertinib mesylate “receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy” NCT06956001
Known as Furmonertinib Furmonertinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both sensitising EGFR and EGFR Thr790Met (T790M)...” PMID 33780662 Mar 2021
61

“The efficacy of Furmonertinib combined with OMMAYA lateral ventricle chemotherapy (pemetrexed) was evaluated once a week during the treatment phase.” NCT06315686

“All patients receive first-line oral therapy with standard-dose third-generation EGFR-TKIs (osimertinib, aumolertinib, or furmonertinib).” NCT07637448

“Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.” NCT04401059

Furmonertinib is a novel third-generation EGFR-TKI with excellent efficacy and a favorable safety profile.” NCT07548060

“receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles” NCT05430802

“Study Drug: Furmonertinib (Shanghai Allist Pharmaceuticals Co.,Ltd.)” NCT06969781

“RC108 plus Furmonertinib and/or Toripalimab” NCT05821933

Furmonertinib: 80 mg per dose, once daily” NCT07458919

furmonertinib 160mg once daily” NCT07398599

NCT05334277

NCT07169994

NCT06537297

NCT07087223

NCT04965831

NCT05445310

NCT04671303

NCT07517640

NCT05165355

NCT05607550

NCT04858958

NCT06483672

NCT05994131

NCT05364073

NCT04895930

NCT06652048

NCT05548348

NCT05847764

NCT06192849

NCT07193160

NCT07229599

NCT04970693

NCT06185400

NCT06970639

NCT06339242

NCT06728865

NCT06394674

NCT05465343

NCT07348965

NCT06319950

NCT04982900

NCT07622186

NCT06643000

NCT05255406

NCT06945705

NCT06585644

NCT05079022

NCT05987826

NCT04958967

NCT07482605

NCT07304739

NCT05379803

NCT04853342

NCT05503667

NCT06812871

NCT05813522

NCT07655622

NCT06452433

NCT06674343

NCT06962865

NCT05466149

NCT07365410

Known as Furmonertinib Mesilate “The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).” NCT04858958
1

Furmonertinib Mesilate Tablets” NCT06970639

Known as Furmonertinib Mesylate Furmonertinib Mesylate:The dose of Furmonertinib Mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.” NCT04671303
1

NCT06868732

Known as Furmonertinib(AST2818) Furmonertinib(AST2818)NCT05987826
Known as Ivesa ChEMBL registry synonym — accepted as the source's own label CHEMBL4297258
Action Inhibit “Alflutinib (AST2818) is a newly developed third-generation EGFR tyrosine kinase inhibitor selective for EGFR-sensitizing and T790M-resistant mutations.” PMID 32007598 Jan 2020
Modality Small molecule “irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor” PMID 35662408 Jun 2022
Route Oral “patients received alflutinib orally until disease progression, unacceptable toxicity, or subject withdrawal.” PMID 32007598 Jan 2020
Target EGFR “Alflutinib (AST2818) is a newly developed third-generation EGFR tyrosine kinase inhibitor selective for EGFR-sensitizing and T790M-resistant mutations.” PMID 32007598 Jan 2020