Clinical Trials

Multiple clinical trials, primarily sponsored by Takeda and Millennium Pharmaceuticals, evaluate mobocertinib (TAK788) across Phase 1 through Phase 3. These studies investigate non-small cell lung cancer (NSCLC) alongside pharmacokinetic assessments in healthy volunteers and subjects with hepatic or renal impairment. Across these studies, recruitment statuses encompass completed, active not recruiting, approved for marketing, and withdrawn categories.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04129502 ACTIVE_NOT_RECRUITING
Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Takeda
 2020-01-10 PHASE3
NCT02716116 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Takeda
 2016-06-16 PHASE1; PHASE2
NCT05863819 Withdrawn
Non-small Cell Lung Cancer (NSCLC)
Takeda
 2024-03-30 --
NCT04576208 WITHDRAWN
Non-Small Cell Lung Cancer (NSCLC)
Takeda
 2020-11-30 PHASE2
NCT04056455 COMPLETED
Renal Impairment; Healthy Volunteers
Millennium Pharmaceuticals, Inc.
 2020-03-04 PHASE1
NCT04056468 COMPLETED
Hepatic Impairment; Healthy Volunteers
Millennium Pharmaceuticals, Inc.
 2020-10-09 PHASE1
NCT03807778 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
Takeda
 2019-02-04 PHASE1
NCT04051827 COMPLETED
Carcinoma, Non-Small-Cell Lung; Lung Neoplasms
Millennium Pharmaceuticals, Inc.
 2019-12-23 PHASE1
NCT04576208 Withdrawn
Non-Small Cell Lung Cancer (NSCLC)
Takeda
 2020-11-30 Phase 2
NCT04056468 Completed
Hepatic Impairment|Healthy Volunteers
Millennium Pharmaceuticals Inc.|Takeda
 2020-10-09 Phase 1
NCT04441255 COMPLETED
Healthy Volunteers
Takeda
 2020-07-01 PHASE1
NCT04441255 Completed
Healthy Volunteers
Takeda
 2020-07-01 Phase 1
NCT04056455 Completed
Renal Impairment|Healthy Volunteers
Millennium Pharmaceuticals Inc.|Takeda
 2020-03-04 Phase 1
NCT04051827 Completed
Carcinoma Non-Small-Cell Lung|Lung Neoplasms
Millennium Pharmaceuticals Inc.|Takeda
 2019-12-23 Phase 1
NCT03928327 COMPLETED
Healthy Volunteers
Millennium Pharmaceuticals, Inc.
 2019-05-02 PHASE1
NCT03811834 COMPLETED
Healthy Volunteers
Millennium Pharmaceuticals, Inc.
 2019-01-22 PHASE1
NCT03482453 COMPLETED
Healthy Volunteers
Millennium Pharmaceuticals, Inc.
 2018-03-28 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-30)

Check the Mobocertinib (TAK788) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mobocertinib is a potent, small-molecule kinase inhibitor that selectively binds to epidermal growth factor receptor (EGFR) and HER2 target mutations, thereby inhibiting downstream receptor autophosphorylation and intracellular signaling cascades. This targeted inhibition suppresses tumor cell proliferation and survival, providing therapeutic efficacy in patients with non-small cell lung cancer harboring EGFR mutations.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.