HT-2157 Clinical Trials

Size	Price	Qty
5mg	USD 347
25mg	USD 970

Clinical Trials

A clinical trial sponsored by Dart NeuroScience LLC evaluated the therapeutic potential of HT-2157 across Phase 1 and Phase 2 studies. This completed investigation assessed the safety, tolerability, and pharmacokinetics of the compound in healthy volunteers, followed by its efficacy in patients with major depressive disorder. The study provides key preliminary data on galanin-3 receptor inhibition for neuropsychiatric indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01413932	Completed	Healthy Volunteers (Part 1)\|Major Depressive Disorder (Part 2)	Dart NeuroScience LLC	2011-07	Phase 1\|Phase 2

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

Check the HT-2157 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HT-2157 acts as a selective, high-affinity competitive antagonist of the galanin-3 receptor (Gal3), effectively blocking galanin-mediated neuropeptide signaling pathways and downstream intracellular signaling cascades involved in mood regulation. By inhibiting Gal3 receptor activation within central nervous system circuits, the compound modulates stress and affective pathways, providing a mechanistic rationale for its clinical evaluation in major depressive disorder.

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>).