Serabelisib (TAK-117) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 327

Clinical Trials

Several clinical trials sponsored by Millennium Pharmaceuticals Inc. and Takeda have evaluated serabelisib (TAK-117) across oncological indications, including advanced nonhematologic malignancies, non-small cell lung cancer, and metastatic solid tumors. These investigations, currently listed as completed or terminated, encompassed Phase I pharmacokinetic and dose-escalation evaluations alongside Phase I/II combination studies. Together, these clinical trials provide critical insights into the safety, pharmacokinetics, and therapeutic potential of serabelisib in solid malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02625259	Completed	Neoplasm Advanced or Metastatic	Millennium Pharmaceuticals Inc.\|Takeda	2016-01-08	Phase 1
NCT02393209	Terminated	Non-small Cell Lung Cancer	Millennium Pharmaceuticals Inc.\|Takeda	2015-06-03	Phase 1\|Phase 2
NCT01899053	Completed	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals Inc.\|Takeda	2013-06-28	Phase 1
NCT01449370	Completed	Metastatic Solid Tumors	Millennium Pharmaceuticals Inc.\|Takeda	2011-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Serabelisib (TAK-117) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Serabelisib selectively binds to and inhibits the alpha isoform of phosphoinositide 3-kinase (PI3Kα), suppressing downstream AKT phosphorylation and disrupting lipid kinase signaling required for cellular growth. This target blockade induces cell cycle arrest and apoptosis, thereby inhibiting tumor growth and disease progression in conditions such as non-small cell lung cancer and metastatic solid tumors.

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>).