TAK-063 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple completed clinical trials sponsored by Takeda have evaluated TAK-063 across Phase 1 and Phase 2 studies. Phase 1 trials in healthy volunteers assessed safety, pharmacokinetics, positron emission tomography target engagement, and pharmacodynamic effects on ketamine-induced brain activity and psychotic-like symptoms. Subsequent Phase 2 research evaluated the therapeutic efficacy and safety profile of TAK-063 in patients with schizophrenia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02477020	COMPLETED	Schizophrenia	Takeda	2015-07-01	PHASE2
NCT01892189	COMPLETED	Ketamine-Induced Brain Activity Changes; Psychotic-like Symptoms	Takeda	2013-08	PHASE1
NCT01879722	COMPLETED	Schizophrenia	Takeda	2013-06	PHASE1
NCT02370602	COMPLETED	Healthy Volunteers	Takeda	2013-10	PHASE1
NCT02370602	Completed	Healthy Volunteers	Takeda	2013-10	Phase 1
NCT01892189	Completed	Ketamine-Induced Brain Activity Changes\|Psychotic-like Symptoms	Takeda	2013-08	Phase 1
NCT01879722	Completed	Schizophrenia	Takeda	2013-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-05-08)

Check the TAK-063 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-063 selectively binds to and inhibits phosphodiesterase 10A (PDE10A) with subnanomolar affinity, preventing the enzymatic degradation of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). The resulting accumulation of these cyclic nucleotides in medium spiny neurons enhances striatal signaling pathways, providing the mechanistic basis for its therapeutic evaluation in schizophrenia and psychotic-like symptoms.

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>).