Clinical Trials

Several clinical trials sponsored by Takeda are investigating TAK-861 (Oveporexton) to evaluate its safety, efficacy, and tolerability in patients with central hypersomnia conditions, specifically Narcolepsy Type 1 (including Narcolepsy With Cataplexy) and Narcolepsy Type 2. Spanning Phase 2 and Phase 3 evaluations, these studies encompass completed trials, active not recruiting studies, and actively recruiting long-term extension protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05816382 RECRUITING
Narcolepsy Type 1
Takeda
 2023-04-05 PHASE2; PHASE3
NCT07363720 ACTIVE_NOT_RECRUITING
Narcolepsy Type 1 (NT1); Narcolepsy With Cataplexy
Takeda
 2026-01-29 PHASE3
NCT06505031 COMPLETED
Narcolepsy Type 1
Takeda
 2024-10-08 PHASE3
NCT06470828 COMPLETED
Narcolepsy Type 1
Takeda
 2024-07-02 PHASE3
NCT05687903 COMPLETED
Narcolepsy Type 1
Takeda
 2023-01-09 PHASE2
NCT05687916 COMPLETED
Narcolepsy Type 2
Takeda
 2023-01-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-05)

Check the TAK-861 (Oveporexton) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-861 functions as a potent, selective agonist of orexin receptor 2 (OX2R), stimulating intracellular calcium mobilization and inducing membrane depolarization in histaminergic neurons of the tuberomammillary nucleus. By restoring downstream orexinergic signaling and promoting wakefulness-related neuronal activity, TAK-861 targets the primary pathophysiological deficits evaluated in clinical trials for Narcolepsy Type 1 and Narcolepsy Type 2.

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.