Drugs / Limertinib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | First-line treatment of EGFR exon 19 deletion or exon 21 L858R NSCLC | 2024-10-08 | “Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China’s National Drug Administration (NMPA):” innoventbio.com ↗ “Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China’s National Drug Administration (NMPA)” innoventbio.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05631678 | Jun → Aug 2022 | — | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07612137 | Jun 2026 → Jun 2027 expected | cancer | Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT03502850 | Nov 2017 → Jan 2021 | — | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07001995 | May 2026 → Dec 2027 expected | non-small cell lung carcinoma, small cell lung carcinoma | Hunan Province Tumor Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07413952 | Apr 2026 → Dec 2027 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07323056 | Jan → Jun 2026 overdue | non-small cell lung carcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT07038460 | Jul 2025 → Dec 2027 expected | non-small cell lung carcinoma | Wen-zhao ZHONG | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07109531 | Aug 2025 → Oct 2027 expected | — | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06982924 Comparator | Jun 2025 → Dec 2026 expected | lung cancer | Shanghai Chest Hospital | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-12-07 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces Inclusion of Seven Innovative Drugs including TYVYT New Indication and SYCUME in China's National Reimbursement Drug List innoventbio.com ↗
We are pleased with the NRDL inclusion of our seven innovative therapies this year. |
| 2025-04-26 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharma, for the First-line Treatment of Lung Cancer innoventbio.com ↗
China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations. |
| 2025-01-20 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announce NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharm, for the Treatment of Lung Cancer innoventbio.com ↗ |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Limertinib | “Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth...” PMID 37811634 ↗ Oct 20238“Limertinib (ASK120067) is a newly developed third-generation EGFR tyrosine kinase inhibitor targeting both sensitizing EGFR and EGFR Thr790Met (T790M) mutations.” PMID 35659581 ↗ Jun 2022 |
| Known as | ASK120067 | “Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth...” PMID 37811634 ↗ Oct 20232“Limertinib (ASK120067) is a novel third-generation EGFR tyrosine kinase inhibitor with favorable central nervous system penetration and encouraging intracranial antitumor activity.” NCT07413952 ↗ “Limertinib (ASK120067) is a newly developed third-generation EGFR tyrosine kinase inhibitor targeting both sensitizing EGFR and EGFR Thr790Met (T790M) mutations.” PMID 35659581 ↗ Jun 2022 |
| Action | Inhibit | “Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell” NCT03502850 ↗ |
| Modality | Small molecule | “Limertinib (ASK120067) is a newly developed third-generation EGFR tyrosine kinase inhibitor targeting both sensitizing EGFR and EGFR Thr790Met (T790M) mutations.” PMID 35659581 ↗ Jun 2022 |
| Route | Oral | “Patients received limertinib 160 mg orally twice daily until disease progression or unacceptable toxicity.” PMID 35659581 ↗ Jun 2022 |
| Target | EGFR | “targeting both sensitizing EGFR and EGFR Thr790Met (T790M) mutations” PMID 35659581 ↗ Jun 2022 |