Drugs / Mobocertinib
Mobocertinib
also known as
TAK-788 · AP-32788 · AP-32788 SUCCINATE · Exkivity · MOBOCERTINIB SUCCINATE · TAK-788 SUCCINATE
Small molecule targets EGFR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | EXKIVITY | — | 2021-09-15 | fda.gov ↗ |
| Filed | US (FDA) | — | EGFR exon 20 insertion-positive metastatic non-small cell lung cancer | — | “FDA has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788)” takeda.com ↗ “Mobocertinib (TAK-788) filing under review in US, China, and other countries.” takeda.com ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT04056468 | Oct 2020 → Feb 2022 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04441255 | Jul → Aug 2020 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04056455 | Mar 2020 → Apr 2022 | impaired renal function disease | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04051827 | Dec 2019 → Dec 2020 | non-small cell lung carcinoma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03928327 | May → Aug 2019 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03807778 | Feb 2019 → Nov 2021 overdue | non-small cell lung carcinoma | Takeda | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03811834 | Jan → Mar 2019 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03482453 | Mar → Dec 2018 | — | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02716116 | Jun 2016 → Oct 2026 expected | non-small cell lung carcinoma | Takeda | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04576208 | Nov 2020 → Jul 2022 | non-small cell lung carcinoma | Takeda | Withdrawn | No outcome recorded Stop: Business |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT04129502 | Jan 2020 → Oct 2026 expected | non-small cell lung carcinoma | Takeda | Active not recruiting | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04535557 | — | non-small cell lung carcinoma | Millennium Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-10-02 | Takeda | Regulatory Takeda Provides Update on EXKIVITY® (mobocertinib) takeda.com ↗
Takeda intends to similarly initiate voluntary withdrawal globally where EXKIVITY is approved and is working with regulators in other countries where it is currently available on next steps. |
| 2023-01-11 | Takeda | Regulatory Takeda’s EXKIVITY ® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC takeda.com ↗ |
| 2021-09-15 | Takeda | Regulatory Takeda’s EXKIVITY™ (mobocertinib) Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC takeda.com ↗
This indication is approved under Accelerated Approval based on overall response rate (ORR) and DoR. |
| 2021-05-19 | Takeda | Results Takeda Presents Updated Results for Mobocertinib, Further Substantiating the Clinical Benefit in Patients with EGFR Exon20 Insertion+ mNSCLC takeda.com ↗
The results showed mobocertinib continued to demonstrate clinically meaningful benefit after over a year of follow up and will be presented at the virtual 57 th American Society of Clinical Oncology (ASCO) Annual Meeting on June 4. |
| 2021-04-27 | Takeda | Regulatory Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer takeda.com ↗
the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for mobocertinib (TAK-788) |
| 2021-01-28 | Takeda | Results Takeda Presents Positive Results for Mobocertinib in Patients with EGFR Exon20 Insertion+ mNSCLC who Received Prior Platinum-Based Chemotherapy takeda.com ↗
Mobocertinib, an oral targeted therapy, demonstrated clinically meaningful responses, with a confirmed objective response rate of 35% as assessed by investigator and 28% as assessed by an independent review committee (IRC) |
| 2020-09-18 | Takeda | Results Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress takeda.com ↗
Positive 10-Month Follow-Up Data from Phase 1/2 Trial Reaffirm Mobocertinib’s Previously Reported Results in Patients with EGFR Exon20 Insertion+ Metastatic NSCLC |
| 2020-04-27 | Takeda | Regulatory Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug mobocertinib (TAK-788) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. |
| 2019-06-03 | Takeda | Results Takeda Presents Results from Lung Portfolio Including Phase 1/2 Study of TAK-788 in a Rare Form of NSCLC and New Data on Overall Health-Related Quality of Life for ALUNBRIG ® (brigatinib) takeda.com ↗
Results from a Phase 1/2 first-in-human, open-label, multicenter study showed TAK-788 yielded a median progression-free survival (PFS) of 7.3 months and a confirmed objective response rate (ORR) of 43% in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor ( EGFR ) exon 20 insertion mutations. |
All press releases naming this drug 9 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mobocertinib | “Mobocertinib is a kinase inhibitor designed to selectively target epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations in non-small cell lung cancer.” PMID 39815458 ↗ Jan 20256“This study is about a medicine called TAK-788, also known as mobocertinib, given to adults with non-small cell lung cancer.” NCT02716116 ↗ |
| Known as | AP-32788 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650319 ↗ |
| Known as | AP-32788 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650319 ↗ |
| Known as | Exkivity | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650319 ↗ |
| Known as | MOBOCERTINIB SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650319 ↗ |
| Known as | TAK-788 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03928327 ↗ |
| Known as | TAK-788 SUCCINATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650319 ↗ |
| Action | Inhibit | “oral inhibitor of EGFR exon 20 insertion mutations” PMID 38789848 ↗ May 2024 |
| Modality | Small molecule | “Mobocertinib (TAK-788) is a first-in-class oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor” PMID 38789848 ↗ May 2024 |
| Route | Oral | “This phase 1/2 study will evaluate the safety, pharmacokinetics, and anti-tumor activity of oral EGFR/HER2 Inhibitor TAK-788” NCT02716116 ↗ |
| Target | EGFR | “Mobocertinib, an oral epidermal growth factor receptor (EGFR) inhibitor targeting EGFR gene mutations” PMID 33632775 ↗ Feb 2021 |