Drugs / Befotertinib

Trials 12 · a red edge is where a trial was stopped

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 13 trials
Phase 1 NCT06015568 Sep 2023 → Nov 2028 expected non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT04464551 Dec 2020 → Aug 2021 non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Unknown No outcome recorded
Phase 1 NCT03452150 Jan 2018 → Aug 2020 non-small cell lung carcinoma InventisBio Co., Ltd Completed No outcome recorded
Phase 26 trials
Phase 2 NCT07410611 Feb 2026 → Feb 2030 expected non-small cell lung carcinoma Hebei Medical University Fourth Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07181499 Sep 2025 → Nov 2028 expected non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06863506 Oct 2024 → Jun 2027 expected non-small cell lung carcinoma Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
Phase 2 NCT06517953 Jul 2024 → Jul 2026 overdue non-small cell lung carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 2 NCT05007938 Aug 2021 → Dec 2024 overdue non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Active not recruiting No outcome recorded
Phase 2 NCT03861156 Feb 2019 → Aug 2021 non-small cell lung carcinoma InventisBio Co., Ltd Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04206072 Dec 2019 → Jul 2022 non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Completed No outcome recorded
Phase 31 trial
Phase 3 NCT06041776 Mar 2023 → Apr 2028 expected non-small cell lung carcinoma Betta Pharmaceuticals Co., Ltd. Recruiting No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT06755684 Background Nov 2024 → Dec 2025 overdue non-small cell lung carcinoma Peng Zhang Recruiting No outcome recorded
Phase 41 trial
Phase 4 NCT06561620 Comparator May 2024 → May 2027 expected Fudan University Recruiting No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Befotertinib Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 May 2023
11

Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 Jun 2022

Befotertinib: Oral administration, taken on an empty stomach or with food.” NCT07458919

NCT06755684

NCT05007938

NCT06041776

NCT06517953

NCT06863506

NCT07410611

NCT06561620

NCT07181499

NCT06015568

Known as D-0316 “Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 May 2023
4

“Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 Jun 2022

“Drug:Befotertinib (75 mg or 100 mg orally, once daily) Other name:D-0316NCT06015568

NCT03452150

NCT04464551

Action Inhibit “EGFR mutant-selective inhibitor” PMID 35274722 Mar 2022
Modality Small molecule “Befotertinib (D-0316) is a novel, selective oral third-generation epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor.” PMID 37244266 May 2023
Route Oral “daily oral D-0316 administration” PMID 35274722 Mar 2022
Target EGFR “Befotertinib (D-0316) is a novel, third-generation EGFR tyrosine kinase inhibitor (TKI).” PMID 35724798 Jun 2022