EMPA Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 357

Clinical Trials

Multiple clinical trials are currently evaluating this compound across diverse therapeutic indications, including liver failure associated with cirrhosis, heart failure, metabolic deficits induced by antipsychotic medications, and glycogen storage disease type IB. Spanning Phase 1, Phase 2, Phase 3, and unclassified phases, these studies are sponsored by academic and pharmaceutical entities such as Yale University, Boehringer Ingelheim, Tanta University, and Hong Kong Children's Hospital. Across the portfolio, recruitment statuses range from actively recruiting and not yet recruiting to unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05726032	Recruiting	Cirrhosis\|Liver Failure	Yale University\|Boehringer Ingelheim	2023-09-11	Phase 2
NCT05553938	Recruiting	Heart Failure	Yale University	2023-08-04	Phase 1
NCT05669742	Not yet recruiting	Sodium-glucose Transport Protein Two Inhibitor (SGLT2)Metabolic Deficits Caused by Antipsychotics	Tanta University	2023-01	Phase 3
NCT04986735	Unknown status	Glycogen Storage Disease Type IB	Hong Kong Children''s Hospital	2021-08-08	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

EMPA selectively binds to the orexin 2 (OX2) receptor with high affinity, thereby inhibiting downstream intracellular G-protein signaling cascades and suppressing orexin-dependent cell activation. By disrupting OX2 receptor signaling, the compound modulates physiological processes relevant to metabolic and cardiovascular regulation, connecting to clinical evaluations in metabolic deficits and heart failure.

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>).